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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01492426
First received: December 13, 2011
Last updated: April 28, 2016
Last verified: April 2016
  Purpose
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

Condition Intervention Phase
Hepatitis C
Drug: Daclatasvir
Drug: Telaprevir
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) [ Time Frame: Week 12 (Follow-up period) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12 [ Time Frame: Week 4, Week 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24) [ Time Frame: Week 24 (Follow-up period) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) [ Time Frame: Week 12 (Follow-up period) ] [ Designated as safety issue: No ]
    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.


Enrollment: 605
Study Start Date: January 2012
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daclatasvir + Peginterferon alfa-2a + Ribavirin Drug: Daclatasvir
Film-coated tablet, oral, 60 mg, once daily, 24 weeks
Other Name: BMS-790052
Drug: Peginterferon alfa-2a
Solution for injection, subcutaneous injection, 180 μg, weekly
Other Name: Pegasys®
Drug: Ribavirin
Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
Other Name: Copegus®
Experimental: Telaprevir + Peginterferon alfa-2a + Ribavirin Drug: Telaprevir
Film-coated tablet, oral, 750 mg, 3 times daily
Other Name: Incivek®
Drug: Peginterferon alfa-2a
Solution for injection, subcutaneous injection, 180 μg, weekly
Other Name: Pegasys®
Drug: Ribavirin
Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
Other Name: Copegus®

Detailed Description:
Allocation: Randomized Stratified
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492426

  Show 91 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01492426     History of Changes
Other Study ID Numbers: AI444-052  2011-004237-14 
Study First Received: December 13, 2011
Results First Received: August 17, 2015
Last Updated: April 28, 2016
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal Office for Safety in Health Care
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
Brazil: National Health Surveillance Agency
Brazil: National Committee of Ethics in Research
Canada: Health Canada
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Poland: National Institute of Medicines
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:
Hepatitis C Virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016