Study comparing BMS-790052 (daclatasvir) to telaprevir combined with peginterferon-alfa-2a and ribavirin in untreated hepatitis C patients

Conditions: Chronic Hepatitis C
MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-004237-14-DK

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 900

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
Timepoint(s) of evaluation of this end point: Follow-up Week 12;Main Objective: The purpose of this study is to compare the effectiveness of BMS-790052 (daclatasvir) and telaprevir when given in combination with peginterferon-alpha 2a and ribavirin in genotype 1b patients<br>;Secondary Objective: Proportion of genotype 1b patients with :<br>• hemoglobin value < 10 g/dL;<br>• rash events;<br>• HCV RNA undetectable at Week 12;<br>• HCV RNA undetectable at Week 4;<br>• HCV RNA undetectable at Weeks 4 and 12;<br>• SVR24;<br>• SVR12 based on IL28B genotype.;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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Proportion of genotuype 1b 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 and 12<br>6) SVR24 <br>7) SVR12 based on IL28B genotype<br>8) Genotype 1a patients with SVR12.<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