Skip to main content
OpenTrials
Completed

NCT Number: NCT01492426

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Ciudad de Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

About this study

Allocation: Randomized Stratified

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daclatasvir

Drug

Film-coated tablet, oral, 60 mg, once daily, 24 weeks

Other names: BMS-790052

Telaprevir

Drug

Film-coated tablet, oral, 750 mg, 3 times daily

Other names: Incivek®

Peginterferon alfa-2a

Drug

Solution for injection, subcutaneous injection, 180 μg, weekly

Other names: Pegasys®

Ribavirin

Drug

Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day

Other names: Copegus®

Primary outcomes

  1. Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

    Time frame: Week 12 (Follow-up period)

    SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.

Secondary outcomes

  1. Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4

    Time frame: Week 4

    RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.

  2. Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12

    Time frame: Week 4, Week 12

    eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.

  3. Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)

    Time frame: Week 12

    cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.

  4. Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)

    Time frame: Week 24 (Follow-up period)

    SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.

  5. Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

    Time frame: Week 12 (Follow-up period)

    SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

Acronym: COMMAND-3

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Dec 15, 2011
Registry last updated
Jun 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.