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

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

Registration Number: EUCTR2011-004237-14-IT

Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

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 1
- 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: 0
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: To compare rates of SVR12, defined as HCV RNA < LOQ (detectable or<br>undetectable) at follow-up Week 12, for genotype 1 patients treated<br>with either BMS-790052 or TVR in combination with pegIFNa-2a/RBV;Secondary Objective: To compare the proportion of patients with :<br>• hemoglobin laboratory value < 10 g/dL during the first 12 weeks of<br>treatment;<br>• rash-related dermatologic events of special interest reported during<br>the first 12 weeks of treatment;<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, defined as HCV RNA < LOQ (detectable or undetectable) at<br>follow-up Week 24;<br>• SVR12 by IL28B rs12979860 SNP genotype.;Primary end point(s): Proportion of patients with SVR12, defined as HCV RNA less than limit of<br>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
Secondary end point(s): Proportion of 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;Timepoint(s) of evaluation of this end point: Proportion of 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