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NCT Number: NCT01428063

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

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.

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Key information

Conditions

Hepatitis C Virus Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Buenos Aires, Argentina

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About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daclatasvir

Drug

Other names: BMS-790052

Asunaprevir

Drug

Other names: BMS-650032

Pegylated interferon alfa-2a

Drug

Other names: pegIFNα-2a, Pegasys®

Ribavirin

Drug

Other names: Copegus®

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2011
Registry last updated
May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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