Efficacy and Safety Evaluation of a Treatment Consisting of Peg Interferon Alfa + Ribavirin + Daclatasvir in HCV Genotype 1 and 4 Treatment naïve Patients (COMMAND-Asia)

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Placebo matching Daclatasvir; Drug: Daclatasvir; Drug: Ribavirin; Drug: Peginterferon alfa 2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT01797848

AI444-047

Details and patient eligibility

About

The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients chronically infected with Hepatitis C virus (HCV) GT 1 or 4
• HCV RNA viral load ≥ 10,000 IU/mL
• Naïve to prior treatment with any interferon formulation, Ribavirin (RBV) or HCV direct antiviral agent
• Patients with compensated cirrhosis are permitted

Exclusion criteria

• Infected with HCV other than GT 1 or 4

• Evidence of decompensated liver disease

• Documented or suspected Hepatocellular carcinoma (HCC) as evidenced by previously obtained imaging studies or liver biopsy

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

• History of chronic Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)

• Current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment

• Laboratory values:

  1. Hemoglobin < 12 g/dL (females) or < 13 g/dL (males)
  2. Platelets < 90 x 1000000000 cells/L
  3. Absolute neutrophil count (ANC) < 1.5 × 1000000000 cells/L
  4. Total bilirubin ≥ 34 µmol/L (unless due to Gilbert's disease)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

pegIFNα 2a + Ribavirin + Placebo

Experimental group

Description:

pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 48 weeks Ribavirin 200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 48 weeks Placebo 0 mg Tablets, by mouth, Once daily, 24 weeks

Treatment:

Drug: Peginterferon alfa 2a

Drug: Ribavirin

Drug: Placebo matching Daclatasvir

pegIFNα 2a + Ribavirin + Daclatasvir

Experimental group

Description:

pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 24 or 48 weeks depending on response Ribavirin 1000-1200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 24 or 48 weeks depending on response Daclatasvir 60 mg Tablets, by mouth, Once daily, 24 weeks

Treatment:

Drug: Peginterferon alfa 2a

Drug: Ribavirin

Drug: Daclatasvir