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Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01428063
First received: September 1, 2011
Last updated: April 21, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.

Condition Intervention Phase
Hepatitis C Virus Infection Drug: Daclatasvir Drug: Asunaprevir Drug: Pegylated interferon alfa-2a Drug: Ribavirin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV) [ Time Frame: Week 12 (Follow-up period) ]
    SVR12 defined as HCV RNA<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.


Secondary Outcome Measures:
  • Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12) [ Time Frame: Week 12 (Follow-up period) ]
    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.

  • Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4 [ Time Frame: Week 4 ]
    RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4.

  • Percentage of Participants With Extended Rapid Virologic Response (eRVR) [ Time Frame: Week 4 and 12 ]
    eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12.

  • Percentage of Participants With Complete Early Virologic Response (cEVR) [ Time Frame: Week 12 ]
    cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12.

  • Percentage of Participants With End of the Treatment Response (EOTR) [ Time Frame: End of the study (Week 24) ]
    EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment.

  • Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) [ Time Frame: Week 24 (Follow-up) ]
    SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.

  • Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study [ Time Frame: For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation ]
    AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.


Enrollment: 276
Study Start Date: September 2011
Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin
Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Asunaprevir
Other Name: BMS-650032
Drug: Pegylated interferon alfa-2a
Other Name: pegIFNα-2a, Pegasys®
Drug: Ribavirin
Other Name: Copegus®
Experimental: Daclatasvir + PegIFNα-2a + Ribavirin
Patients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Pegylated interferon alfa-2a
Other Name: pegIFNα-2a, Pegasys®
Drug: Ribavirin
Other Name: Copegus®
Experimental: Daclatasvir + Asunaprevir
Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
Drug: Daclatasvir
Other Name: BMS-790052
Drug: Asunaprevir
Other Name: BMS-650032

Detailed Description:
  • Intervention Model:

    • Parallel: for all patients entering the trial
    • Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial treatment in this study
  • Peginterferon alfa-2a
  • Ribavirin
  • Daclatasvir
  • Asunaprevir
  Eligibility

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

Key Inclusion Criteria:

  • Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to control arm (pegIFNα-2a/ribavirin + placebo) during the trial
  • Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
  • HCV RNA viral load detectable

Key Exclusion Criteria:

  • Discontinuation from a prior BMS HCV clinical trial due to a pegIFNα-2a/ribavirin-related event
  • Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or BMS-791325
  • Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2 antibody at screening
  • Evidence of medical condition associated with chronic liver disease other than HCV infection
  • Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
  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: NCT01428063

  Show 107 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: NCT01428063     History of Changes
Other Study ID Numbers: AI444-026
2011-000836-27 ( EudraCT Number )
Study First Received: September 1, 2011
Results First Received: August 19, 2015
Last Updated: April 21, 2016

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

ClinicalTrials.gov processed this record on September 21, 2017