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)

November 21, 2013 updated by: Bristol-Myers Squibb

A Phase 3 Randomized, Double Blind, Multi-National Evaluation of Daclatasvir in Combination With Peg Interferon Alfa-2a and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotypes 1 and 4

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pegIFNα 2a + Ribavirin + Placebo

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
Drug: Ribavirin
Other Names:
  • Copegus® (Taiwan, Korea and Singapore)
  • Wei Lining (China)
Drug: Peginterferon alfa 2a
Other Names:
  • Pegasys®
Drug: Placebo matching Daclatasvir
Experimental: pegIFNα 2a + Ribavirin + Daclatasvir

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
Drug: Ribavirin
Other Names:
  • Copegus® (Taiwan, Korea and Singapore)
  • Wei Lining (China)
Drug: Daclatasvir
Other Names:
  • BMS-790052-05
Drug: Peginterferon alfa 2a
Other Names:
  • Pegasys®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort
Time Frame: Week 24 post treatment follow up
Week 24 post treatment follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Genotype (GT) 4 subjects with SVR24
Time Frame: Week 24 post treatment follow up visit
Week 24 post treatment follow up visit
Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable
Time Frame: Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12)
Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12)
Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs)
Time Frame: Up to 48 weeks plus 30 days
Up to 48 weeks plus 30 days
Discontinuations due to Adverse Events (AEs)
Time Frame: Up to 48 weeks plus 7 days
Up to 48 weeks plus 7 days
Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene
Time Frame: Up to 72 weeks
Up to 72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI444-047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Clinical Trials on Ribavirin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe