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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C | Drug: Daclatasvir Drug: Telaprevir Drug: Peginterferon alfa-2a Drug: Ribavirin | Phase 3 |
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 |

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® |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
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 |
Hepatitis C Virus |
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 |