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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01257204
Registration number
NCT01257204
Ethics application status
Date submitted
1/12/2010
Date registered
9/12/2010
Date last updated
14/12/2015
Titles & IDs
Public title
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
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Scientific title
A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection
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Secondary ID [1]
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2010-022408-28
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Secondary ID [2]
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AI444-031
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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 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
Treatment: Drugs - Placebo
Treatment: Drugs - Daclatasvir
Treatment: Drugs - Pegylated interferon alfa-2a
Treatment: Drugs - Ribavirin
Active comparator: Control - Placebo + Pegylated interferon alfa-2a + Ribavirin
Experimental: 12 Week Cohort - Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
Experimental: 16 Week Cohort - Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
Treatment: Drugs: Placebo
Tablets, oral, 0 mg, once daily, for 24 weeks
Treatment: Drugs: Daclatasvir
Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
Treatment: Drugs: Pegylated interferon alfa-2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
Treatment: Drugs: Ribavirin
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
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Intervention code [1]
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Treatment: Drugs
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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 Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
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Assessment method [1]
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SVR24 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [1]
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Follow-up Week 24
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Primary outcome [2]
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Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3
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Assessment method [2]
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SVR24 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [2]
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Follow-up Week 24
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Secondary outcome [1]
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Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2
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Assessment method [1]
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RVR was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at Week 4. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [1]
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Week 4
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Secondary outcome [2]
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Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3
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Assessment method [2]
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RVR was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at Week 4. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [2]
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Week 4
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Secondary outcome [3]
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Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2
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Assessment method [3]
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cEVR was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at Week 12. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3
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Assessment method [4]
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cEVR was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at Week 12. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2
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Assessment method [5]
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SVR12 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 12. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [5]
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Follow-up Week 12
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Secondary outcome [6]
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Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3
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Assessment method [6]
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SVR12 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 12. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [6]
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Follow-up Week 12
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Secondary outcome [7]
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Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
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Assessment method [7]
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Virologic failure was defined as:
1. Virologic breakthrough: confirmed \>1 log10 increase in HCV RNA over nadir or confirmed RNA =lower limit of quantitation (LLOQ) after confirmed HCV RNA \<LLOQ, target not detected (TND) while on treatment
2. \<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment
3. Failure to achieve early virologic response: \<2 log10 decrease in HCV RNA from baseline and HCV RNA =LLOQ at Week 12 of treatment
4. HCV RNA =LLOQ or \<LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
5. Relapse, defined as HCV RNA =LLOQ or \<LLOQ, TD during follow-up, after HCV RNA \<LLOQ, TND at EOT.
The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [7]
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Baseline up to Week 48
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Secondary outcome [8]
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Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
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Assessment method [8]
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Virologic failure was defined as:
1. Virologic breakthrough: confirmed \>1 log10 increase in HCV RNA over nadir or confirmed RNA =lower limit of quantitation (LLOQ) after confirmed HCV RNA \<LLOQ, target not detected (TND) while on treatment
2. \<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment
3. Failure to achieve early virologic response: \<2 log10 decrease in HCV RNA from baseline and HCV RNA =LLOQ at Week 12 of treatment
4. HCV RNA =LLOQ or \<LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
5. Relapse, defined as HCV RNA =LLOQ or \<LLOQ, TD during follow-up, after HCV RNA \<LLOQ, TND at EOT.
The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Timepoint [8]
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Baseline up to Week 48
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Secondary outcome [9]
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
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Assessment method [9]
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AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.
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Timepoint [9]
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Baseline (Day 1) up to 24 weeks (treatment period)
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Secondary outcome [10]
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period
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Assessment method [10]
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AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
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Timepoint [10]
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From end of treatment period up to Week 48 (follow-up period)
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Eligibility
Key inclusion criteria
Key
* Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3
* No previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin
* Body mass index (BMI) of 18 to 35 kg/m^2, inclusive. BMI=weight (kg)/height (m)^2
* Males and females, 18 - 70 years of age
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Minimum age
18
Years
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Maximum age
70
Years
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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
* Liver transplant recipients
* Documented or suspected hepatocellular carcinoma
* Evidence of decompensated cirrhosis
* History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate
* Current or known history of cancer
* Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug
* Inability to tolerate oral medication
* Poor venous access
* Severe psychiatric disease
* History of chronic pulmonary disease
* History of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant cardiac disease
* History of or current electrocardiogram findings indicative of cardiovascular instability
* Preexisting ophthalmologic disorders considered clinically significant on eye
* History of uncontrolled diabetes mellitus
* Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise specified.
* Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab
* Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase, previous nonstructural protein 5A inhibitors)
* Exposure to any investigational drug or placebo
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
1/12/2010
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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
1/09/2012
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Sample size
Target
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Accrual to date
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Final
196
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - Darlinghurst
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Recruitment hospital [2]
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Local Institution - Westmead Nsw
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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 - Clayton Vic
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Recruitment hospital [5]
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Local Institution - Fremantle
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Recruitment hospital [6]
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Local Institution - Camperdown
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2145 - Westmead Nsw
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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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3168 - Clayton Vic
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Recruitment postcode(s) [5]
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6160 - Fremantle
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Recruitment postcode(s) [6]
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NSW 2050 - Camperdown
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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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Maryland
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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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Oklahoma
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Canada
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State/province [5]
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Alberta
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Country [6]
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Canada
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State/province [6]
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British Columbia
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Country [7]
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Canada
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State/province [7]
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Manitoba
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Country [8]
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Canada
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State/province [8]
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Ontario
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Country [9]
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Denmark
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State/province [9]
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Hvidovre
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Country [10]
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France
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State/province [10]
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Creteil
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Country [11]
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France
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State/province [11]
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Lille Cedex
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Country [12]
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France
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State/province [12]
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Montpellier Cedex 5
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Country [13]
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France
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State/province [13]
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Nice Cedex 03
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Country [14]
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France
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State/province [14]
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Paris Cedex 14
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Country [15]
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France
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State/province [15]
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Pessac
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Country [16]
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Italy
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State/province [16]
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Brescia
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Country [17]
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Italy
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State/province [17]
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Cisanello (pisa)
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Country [18]
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Italy
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State/province [18]
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Viale Del Policlinico, 155
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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
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.
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Trial website
https://clinicaltrials.gov/study/NCT01257204
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Trial related presentations / publications
Dore GJ, Lawitz E, Hezode C, Shafran SD, Ramji A, Tatum HA, Taliani G, Tran A, Brunetto MR, Zaltron S, Strasser SI, Weis N, Ghesquiere W, Lee SS, Larrey D, Pol S, Harley H, George J, Fung SK, de Ledinghen V, Hagens P, McPhee F, Hernandez D, Cohen D, Cooney E, Noviello S, Hughes EA. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. Gastroenterology. 2015 Feb;148(2):355-366.e1. doi: 10.1053/j.gastro.2014.10.007. Epub 2014 Oct 13.
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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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Country
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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/NCT01257204
Download to PDF