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: 16.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-004237-14-AT
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-29
• Last Update Posted: 22 July 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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