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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01168856
Registration number
NCT01168856
Ethics application status
Date submitted
15/07/2010
Date registered
23/07/2010
Date last updated
11/03/2016
Titles & IDs
Public title
An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens
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Scientific title
A Long-term Monitoring Study to Evaluate the Persistence of Direct Antiviral (DAA) Treatment Resistant Mutations or the Durability of Sustained Virological Response (SVR) in Patients Treated With DAA Containing Regimens for Chronic Hepatitis C Infections (CHC)
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Secondary ID [1]
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0
2009-016560-36
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Secondary ID [2]
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NV22688
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic
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Condition category
Condition code
Infection
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0
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Other infectious diseases
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Oral and Gastrointestinal
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0
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Cohort -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3
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Assessment method [1]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter [IU/mL]).
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Timepoint [1]
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Month 3
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Primary outcome [2]
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Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6
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Assessment method [2]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [2]
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Month 6
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Primary outcome [3]
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Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9
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Assessment method [3]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [3]
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Month 9
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Primary outcome [4]
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Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12
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Assessment method [4]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [4]
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Month 12
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Primary outcome [5]
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Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18
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Assessment method [5]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [5]
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Month 18
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Primary outcome [6]
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HCV RNA Levels in Resistance Monitoring Arm at Month 3
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Assessment method [6]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [6]
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Month 3
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Primary outcome [7]
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HCV RNA Levels in Resistance Monitoring Arm at Month 6
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Assessment method [7]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [7]
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Month 6
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Primary outcome [8]
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HCV RNA Levels in Resistance Monitoring Arm at Month 9
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Assessment method [8]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [8]
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Month 9
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Primary outcome [9]
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HCV RNA Levels in Resistance Monitoring Arm at Month 12
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Assessment method [9]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [9]
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Month 12
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Primary outcome [10]
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HCV RNA Levels in Resistance Monitoring Arm at Month 18
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Assessment method [10]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [10]
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Month 18
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Primary outcome [11]
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Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3
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Assessment method [11]
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Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator.
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Timepoint [11]
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Month 3
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Primary outcome [12]
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Systolic Blood Pressure in Resistance Monitoring Arm at Month 6
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Assessment method [12]
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Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [12]
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Month 6
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Primary outcome [13]
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Systolic Blood Pressure in Resistance Monitoring Arm at Month 9
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Assessment method [13]
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Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [13]
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Month 9
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Primary outcome [14]
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Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12
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Assessment method [14]
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Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [14]
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Month 12
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Primary outcome [15]
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Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18
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Assessment method [15]
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Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [15]
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Month 18
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Primary outcome [16]
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Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3
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Assessment method [16]
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Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [16]
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Month 3
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Primary outcome [17]
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Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6
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Assessment method [17]
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Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [17]
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Month 6
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Primary outcome [18]
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Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9
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Assessment method [18]
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Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [18]
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Month 9
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Primary outcome [19]
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Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12
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Assessment method [19]
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Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [19]
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Month 12
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Primary outcome [20]
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Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18
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Assessment method [20]
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Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [20]
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Month 18
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Primary outcome [21]
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Mean Pulse Rate in Resistance Monitoring Arm at Month 3
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Assessment method [21]
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Any abnormalities in pulse rate were reported at the discretion of principal investigator.
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Timepoint [21]
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Month 3
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Primary outcome [22]
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Mean Pulse Rate in Resistance Monitoring Arm at Month 6
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Assessment method [22]
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Any abnormalities in pulse rate were reported at the discretion of principal investigator.
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Timepoint [22]
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Month 6
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Primary outcome [23]
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Mean Pulse Rate in Resistance Monitoring Arm at Month 9
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Assessment method [23]
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Any abnormalities in pulse rate were reported at the discretion of principal investigator.
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Timepoint [23]
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Month 9
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Primary outcome [24]
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Mean Pulse Rate in Resistance Monitoring Arm at Month 12
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Assessment method [24]
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Any abnormalities in pulse rate were reported at the discretion of principal investigator.
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Timepoint [24]
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Month 12
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Primary outcome [25]
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Mean Pulse Rate in Resistance Monitoring Arm at Month 18
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Assessment method [25]
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Any abnormalities in pulse rate were reported at the discretion of principal investigator.
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Timepoint [25]
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Month 18
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Primary outcome [26]
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Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm
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Assessment method [26]
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Percentage of participants who received any anti-HCV medication during the monitoring period was reported.
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Timepoint [26]
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Up to 18 months
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Primary outcome [27]
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Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6
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Assessment method [27]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [27]
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Month 6
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Primary outcome [28]
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Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12
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Assessment method [28]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [28]
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Month 12
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Primary outcome [29]
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Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24
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Assessment method [29]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [29]
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Month 24
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Primary outcome [30]
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Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36
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Assessment method [30]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [30]
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Month 36
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Primary outcome [31]
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Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6
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Assessment method [31]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [31]
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Month 6
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Primary outcome [32]
0
0
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12
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Assessment method [32]
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0
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [32]
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0
Month 12
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Primary outcome [33]
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0
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24
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Assessment method [33]
0
0
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [33]
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Month 24
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Primary outcome [34]
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0
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36
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Assessment method [34]
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Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
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Timepoint [34]
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Month 36
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Primary outcome [35]
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0
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6
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Assessment method [35]
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0
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [35]
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Month 6
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Primary outcome [36]
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0
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12
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Assessment method [36]
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Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [36]
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Month 12
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Primary outcome [37]
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0
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24
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Assessment method [37]
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Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [37]
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Month 24
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Primary outcome [38]
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0
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36
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Assessment method [38]
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Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [38]
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Month 36
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Primary outcome [39]
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0
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6
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Assessment method [39]
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Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [39]
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Month 6
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Primary outcome [40]
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0
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12
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Assessment method [40]
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Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [40]
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Month 12
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Primary outcome [41]
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0
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24
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Assessment method [41]
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Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [41]
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Month 24
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Primary outcome [42]
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0
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36
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Assessment method [42]
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Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
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Timepoint [42]
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Month 36
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Primary outcome [43]
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Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6
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Assessment method [43]
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Any abnormalities in pulse rate were reported at the discretion of principal investigator.
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Timepoint [43]
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Month 6
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Primary outcome [44]
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Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12
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Assessment method [44]
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Any abnormalities in pulse rate were reported at the discretion of principal investigator.
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Timepoint [44]
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Month 12
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Primary outcome [45]
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Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24
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Assessment method [45]
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Any abnormalities in pulse rate were reported at the discretion of principal investigator.
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Timepoint [45]
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Month 24
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Primary outcome [46]
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Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36
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Assessment method [46]
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Any abnormalities in pulse rate were reported at the discretion of principal investigator.
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Timepoint [46]
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Month 36
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Primary outcome [47]
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Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing
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Assessment method [47]
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Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.
Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis.
Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis.
Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.
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Timepoint [47]
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Month 3-18
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Primary outcome [48]
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Number of Participants With DNV Resistance Status-Clonal Sequencing
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Assessment method [48]
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Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.
Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis.
Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis.
Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study.
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Timepoint [48]
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Month 3-18
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Primary outcome [49]
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0
Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing
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Assessment method [49]
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Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.
Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis.
Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis.
Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.
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Timepoint [49]
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Month 3-18
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Primary outcome [50]
0
0
Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing
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Assessment method [50]
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0
Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.
Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis.
Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis.
Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688.
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Timepoint [50]
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0
Month 3-18
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Primary outcome [51]
0
0
Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing
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Assessment method [51]
0
0
Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.
Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis.
Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis.
Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.
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Timepoint [51]
0
0
Month 3-18
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Primary outcome [52]
0
0
Number of Participants With STV Resistance Status-Clonal Sequencing
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Assessment method [52]
0
0
Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.
Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis.
Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis.
Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688.
Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688.
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Timepoint [52]
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Month 3-18
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Primary outcome [53]
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0
Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688
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Assessment method [53]
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Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.
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Timepoint [53]
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Month 18
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Eligibility
Key inclusion criteria
- adult patients, >/=18 years of age
- chronic hepatitis C
- participation in Roche DAA treatment protocol for CHC infection
- DAA-associated resistant mutations persisting through to last evaluation in donor
protocol , or partial viral response or viral load rebound while on RO5024048
treatment, or sustained virological response >/= 20 weeks after last dose of study
medication in donor study
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- For patients participating in DAA resistance monitoring: Initiation of treatment after
participation in the donor protocol for which there is evidence of cross-resistance to
donor protocol DAA
- For patients participating in DAA SVR durability: Treatment with any anti-HVC therapy
since establishing SVR in the donor study
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2015
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Sample size
Target
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Accrual to date
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Final
734
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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0
- Darlinghurst
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Recruitment hospital [2]
0
0
- Kingswood
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Recruitment hospital [3]
0
0
- Sydney
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Recruitment hospital [4]
0
0
- Westmead
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Recruitment hospital [5]
0
0
- Greenslopes
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Recruitment hospital [6]
0
0
- Herston
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Recruitment hospital [7]
0
0
- Woolloongabba
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Recruitment hospital [8]
0
0
- Adelaide
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Recruitment hospital [9]
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0
- Melbourne
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Recruitment postcode(s) [1]
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0
2010 - Darlinghurst
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Recruitment postcode(s) [2]
0
0
2747 - Kingswood
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Recruitment postcode(s) [3]
0
0
2050 - Sydney
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Recruitment postcode(s) [4]
0
0
2145 - Westmead
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Recruitment postcode(s) [5]
0
0
4120 - Greenslopes
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Recruitment postcode(s) [6]
0
0
4029 - Herston
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Recruitment postcode(s) [7]
0
0
4102 - Woolloongabba
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Recruitment postcode(s) [8]
0
0
5000 - Adelaide
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Recruitment postcode(s) [9]
0
0
3181 - Melbourne
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Recruitment postcode(s) [10]
0
0
3186 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Hawaii
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Illinois
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Indiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Kansas
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Louisiana
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Michigan
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Missouri
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Country [12]
0
0
United States of America
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State/province [12]
0
0
New Hampshire
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Country [13]
0
0
United States of America
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State/province [13]
0
0
New Jersey
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Nottingham
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Funding & Sponsors
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Name
Hoffmann-La Roche
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Summary
Brief summary
This observational long-term follow-up study will assess the persistence of direct acting
antiviral (DAA) resistant mutations and the durability of sustained virological response in
patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up
to 5 scheduled monitoring visits for blood sampling during an observational period of up to
36 months.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01168856
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Clinical Trials
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01168856
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