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: May 31, 2013
Last verified: May 2013
  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:


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: January 2012
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:
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: May 31, 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 April 15, 2014