Study comparing BMS-790052 (daclatasvir) to telaprevir combined with peginterferon-alfa-2a and ribavirin in untreated hepatitis C patients
Phase 1
- Conditions
- Chronic Hepatitis CMedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-004237-14-GB
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 793
Inclusion Criteria
- Subjects chronically infected with HCV genotype 1a or 1b
-HCV RNA viral load =10,000 IU/mL
- No prior treatment including but not limited to interferon, ribavirin and direct-acting antivirals
- if no prior history of cirrhosis
liver biopsy within 3 years or Fibroscan® within 1 year
-Body Mass Index (BMI) of 18 to 35 kg/m2
-Negative for HIV and Hepatitis B
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 810
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
Exclusion Criteria
- Evidence of decompensated liver disease
- Evidence of medical condition contributing to chronic liver disease other than HCV
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to compare the effectiveness of BMS-790052 (daclatasvir) and telaprevir when given in combination with peginterferon-alfa 2a and ribavirin in genotype 1b patients;<br> Secondary Objective: Proportion of genotype1 b patients with :<br> 1) hemoglobin value less than 10 g/dL<br> 2) rash events<br> 3) HCV RNA undetectable Week 12<br> 4) HCV RNA undetectable Week 4<br> 5) HCV RNA undetectable Weeks 4 & 12<br> 6) SVR24 <br> 7) SVR12 based on IL28B genotype<br> 8) genotype1a patients with SVR12<br> ;Primary end point(s): Proportion of genotype 1b patients with SVR12, defined as HCV RNA less than limit of quantitation at follow-up Week 12 in each group;Timepoint(s) of evaluation of this end point: Follow-up Week 12
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Proportion of genotype1 b patients with<br> 1) hemoglobin value less than 10 g/dL<br> 2) rash events<br> 3) HCV RNA undetectable Week 12<br> 4) HCV RNA undetectable Week 4<br> 5) HCV RNA undetectable Weeks 4 & 12<br> 6) SVR24 <br> 7) SVR12 based on IL28B genotype<br> 8) genotype1a patients with SVR12<br> ;<br> Timepoint(s) of evaluation of this end point: 1) Up to Week 12<br> 2) Up to Week 12<br> 3) Week 12<br> 4) Week 4<br> 5) Week 4 and 12<br> 6) Follow-up Week 24<br> 7) Follow-up Week 12<br> 8) Follow-up Week 12<br>