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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)

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ClinicalTrials.gov Identifier: NCT01492426
Recruitment Status : Completed
First Posted : December 15, 2011
Results First Posted : June 3, 2016
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Drug: Daclatasvir Drug: Telaprevir Drug: Peginterferon alfa-2a Drug: Ribavirin Phase 3

Detailed Description:
Allocation: Randomized Stratified
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2014

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Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492426


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

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01492426    
Other Study ID Numbers: AI444-052
2011-004237-14 ( EudraCT Number )
First Posted: December 15, 2011    Key Record Dates
Results First Posted: June 3, 2016
Last Update Posted: June 3, 2016
Last Verified: April 2016
Keywords provided by Bristol-Myers Squibb:
Hepatitis C Virus
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents