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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01741545
Registration number
NCT01741545
Ethics application status
Date submitted
3/12/2012
Date registered
5/12/2012
Date last updated
11/08/2020
Titles & IDs
Public title
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
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Scientific title
A Phase 3 Study Evaluating the Safety and Efficacy of Lambda/Ribavirin/Daclatasvir in Subjects With Chronic HCV Infection and Underlying Hemophilia Who Are Treatment Naïve or Are Prior Relapsers to Peginterferon Alfa-2a/Ribavirin
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Secondary ID [1]
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2012-003463-22
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Secondary ID [2]
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AI452-030
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Universal Trial Number (UTN)
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Trial acronym
MAGNITUDE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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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
Interventional
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Description of intervention(s) / exposure
Experimental: Cohort A: Genotype-2,-3 (Lambda/RBV/DCV) - Lambda 180 µg solution for subcutaneous (SC) injection, once weekly for 12 weeks
Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks
Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
Experimental: Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV) - Lambda 180 µg solution for subcutaneous (SC) injection, once weekly for 24 weeks
Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks
Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
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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 Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12
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Assessment method [1]
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SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.
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Timepoint [1]
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Follow-up Week 12
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Secondary outcome [1]
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Percentage of Participants With Rapid Virologic Response (RVR)
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Assessment method [1]
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RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4.
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Timepoint [1]
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Treatment Week 4
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Secondary outcome [2]
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Percentage of Participants With Complete Early Virologic Response (cEVR)
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Assessment method [2]
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cEVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 12.
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Timepoint [2]
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Treatment Week 12
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Secondary outcome [3]
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Percentage of Participants With End of the Treatment Response (EOTR)
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Assessment method [3]
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EOTR was defined as HCV RNA less than the lower limit of quantitation, target not detected at end of treatment.
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Timepoint [3]
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End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)
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Secondary outcome [4]
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Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)
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Assessment method [4]
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SVR24 was defined as HCV RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.
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Timepoint [4]
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Follow-up Week 24
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Secondary outcome [5]
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Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment
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Assessment method [5]
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Cytopenic abnormalities were defined as anemia: Hemoglobin (Hb) \<10 g/dL, and/or neutropenia: absolute neutrophils and bands (ANC) \<750 mm\^3, and/or thrombocytopenia: platelets \<50,000 mm\^3.
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Timepoint [5]
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After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
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Secondary outcome [6]
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Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment
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Assessment method [6]
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Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain.
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Timepoint [6]
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After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
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Secondary outcome [7]
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Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death
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Assessment method [7]
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AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug.
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Timepoint [7]
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From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
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Secondary outcome [8]
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Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities
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Assessment method [8]
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Laboratory abnormalities were determined and graded using the Division of acquired immunodeficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): \>2.0\*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : \>5\*ULN; Aspartate aminotransferase (AST): \>5\*ULN; Prothrombin Time (PT): \>1.50\*ULN; Bilirubin (Total): \>2.5\*ULN; Triglycerides (fasting): \>750 mg/dL.
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Timepoint [8]
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After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
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Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
* Severe hemophilia (defined as < 1% factor activity level)
* Infection with the hepatitis C virus (HCV) with underlying hemophilia
* Males 18 years of age and above
* Have not been previously treated with an interferon
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Chronic liver disease caused by any disease other than chronic HCV infection
* Presence of Bethesda inhibitor
* Current evidence of or history of portal hypertension
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
31/03/2013
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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
31/01/2015
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Sample size
Target
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Accrual to date
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Final
71
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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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Local Institution - Camperdown
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Recruitment hospital [2]
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Local Institution - Herston
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Recruitment hospital [3]
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Local Institution - Adelaide
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Recruitment hospital [4]
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Local Institution - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Illinois
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Country [3]
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United States of America
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State/province [3]
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Pennsylvania
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Country [4]
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United States of America
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Utah
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Country [5]
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France
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State/province [5]
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Grenoble
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Country [6]
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France
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State/province [6]
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Lyon Cedex 04
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Country [7]
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France
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State/province [7]
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Montpellier Cedex 5
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Country [8]
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France
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State/province [8]
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Paris Cedex 13
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Country [9]
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France
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State/province [9]
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Paris Cedex 14
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France
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State/province [10]
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Vandoeuvre Les Nancy
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Italy
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Firenze
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Italy
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Milan
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Italy
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State/province [13]
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Roma
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Italy
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State/province [14]
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Torino
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Netherlands
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Amsterdam
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Country [16]
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Netherlands
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State/province [16]
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Nijmegen
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Netherlands
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State/province [17]
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Rotterdam
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Netherlands
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State/province [18]
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Utrecht
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Romania
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State/province [19]
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Bucuresti
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Romania
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State/province [20]
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Constanta
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Romania
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State/province [21]
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Iasi
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Country [22]
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Russian Federation
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Moscow
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Russian Federation
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State/province [23]
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Saint Petersburg
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Country [24]
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Spain
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State/province [24]
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Barcelona
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Country [25]
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Spain
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State/province [25]
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Madrid
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Country [26]
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Spain
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State/province [26]
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA \< LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3
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Trial website
https://clinicaltrials.gov/study/NCT01741545
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01741545
Download to PDF