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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01492426
First received: December 13, 2011
Last updated: March 28, 2013
Last verified: December 2012
History of Changes
  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: BMS-790052 (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:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of genotype 1b patients with SVR12, defined as HCV RNA less than limit of quantitation at follow-up Week 12 in each group [ Time Frame: Follow up Week 12 ] [ Designated as safety issue: No ]
    • HCV - Hepatitis C virus
    • RNA - Ribonucleic Acid
    • SVR - Sustained Virologic Response


Secondary Outcome Measures:
  • Proportion of genotype 1b patients with hemoglobin value less than 10 g/dL [ Time Frame: Up to Week 12 ] [ Designated as safety issue: Yes ]
  • Proportion of genotype 1b patients with rash events [ Time Frame: Up to Week 12 ] [ Designated as safety issue: Yes ]
  • Proportion of genotype1b patients with HCV RNA undetectable Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of genotype 1b patients with HCV RNA undetectable Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Proportion of genotype 1b patients with HCV RNA undetectable Weeks 4 and 12 [ Time Frame: Week 4 and 12 ] [ Designated as safety issue: No ]
  • Proportion of genotype 1b patients with SVR24, defined as HCV RNA < Limit of Quantification (LOQ) at follow-up Week 24 for each cohort [ Time Frame: Follow up Week 24 ] [ Designated as safety issue: No ]
  • Proportion of genotype 1b patients with SVR12 based on IL28B rs12979860 Single nucleotide polymorphism (SNP) genotype (CC or non-CC) [ Time Frame: Follow up Week 12 ] [ Designated as safety issue: No ]
  • Proportion of genotype 1a patients with SVR12 defined as HCV RNA < LOQ at follow-up Week 12 for each cohort [ Time Frame: Follow up Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: August 1971
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: BMS-790052 + Peginterferon alfa-2a + Ribavirin Drug: BMS-790052 (Daclatasvir)
Film coated Tablet, Oral, 60 mg, Once daily, 24 weeks
Drug: Peginterferon alfa-2a
Solution for Injection, Subcutaneous injection, 180 μg, Weekly, 24 or 48 weeks
Other Name: Pegasys®
Drug: Ribavirin
Film coated Tablet, Oral, 1000 mg or 1200 mg based on weight, twice daily, 24 or 48 weeks
Other Name: Copegus®
Experimental: Telaprevir + Peginterferon alfa-2a + Ribavirin Drug: Telaprevir
Film coated Tablet, Oral, 750 mg, three times daily, 12 weeks
Other Name: Incivek®
Drug: Peginterferon alfa-2a
Solution for Injection, Subcutaneous injection, 180 μg, Weekly, 24 or 48 weeks
Other Name: Pegasys®
Drug: Ribavirin
Film coated Tablet, Oral, 1000 mg or 1200 mg based on weight, twice daily, 24 or 48 weeks
Other Name: Copegus®

Detailed Description:

Allocation: Randomized Stratified

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects chronically infected with 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
  • if no prior history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
  • Body Mass Index (BMI) of 18 to 35 kg/m2
  • Negative for Human immunodeficiency virus (HIV) and Hepatitis B

Exclusion Criteria:

  • Evidence of decompensated liver disease
  • Evidence of medical condition contributing to chronic liver disease other than HCV
  Contacts and Locations
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:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

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
Last Updated: March 28, 2013
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
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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013