Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection (COMMAND-3)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Peginterferon alfa-2a; Drug: Daclatasvir; Drug: Ribavirin; Drug: Telaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01492426

AI444-052

2011-004237-14 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Allocation: Randomized Stratified

Enrollment: 605 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participants chronically infected with hepatitis C virus (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
• No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
• Body mass index of 18 to 35 kg/m^2
• Negative for HIV and hepatitis B virus

Key Exclusion Criteria:

• Evidence of decompensated liver disease
• Evidence of medical condition other than HCV contributing to chronic liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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605 participants in 2 patient groups

Daclatasvir + Peginterferon alfa-2a + Ribavirin

Experimental group

Treatment:

Drug: Ribavirin

Drug: Daclatasvir

Drug: Peginterferon alfa-2a

Telaprevir + Peginterferon alfa-2a + Ribavirin

Experimental group

Treatment:

Drug: Telaprevir

Drug: Ribavirin

Drug: Peginterferon alfa-2a