EUCTR2011-004237-14-GB
Active, not recruiting
Phase 1
A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared with Telaprevir in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis-C Revised Protocol 02 incorporating protocol amendment 03 (version 1.0 dated 22-Jan-13). + Pharmacogenetics Blood Sample Amendment 01 (version 1.0 dated 23-Nov-11) + Administrative Letter 01 Site Specific dated 27-Mar-2012 - COMMAND-3
ConditionsChronic 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]
DrugsIncivo
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis C
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 793
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •\- Evidence of decompensated liver disease
- •\- Evidence of medical condition contributing to chronic liver disease other than HCV
Outcomes
Primary Outcomes
Not specified
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