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Interferon

Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin for Hepatitis C (HEPCAT Trial)

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 8 post last dose of treatment up-to week 72
Awards & highlights

Summary

The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

Eligible Conditions
  • Hepatitis C

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 8 post last dose of treatment up-to week 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 8 post last dose of treatment up-to week 72 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
+1 more
Secondary study objectives
Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Percentage of Participants With Complete Early Virologic Response (cEVR)
+2 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Arm 5: Placebo plus peginterferon alfa-2a and ribavirinExperimental Treatment3 Interventions
(prior partial responders only)
Group II: Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirinExperimental Treatment3 Interventions
(prior partial responders)
Group III: Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirinExperimental Treatment3 Interventions
(prior partial responders)
Group IV: Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirinExperimental Treatment3 Interventions
(prior null responders)
Group V: Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirinExperimental Treatment3 Interventions
(prior null responders)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daclatasvir
FDA approved
Placebo
1995
Completed Phase 3
~2670
Peginterferon alfa-2a
FDA approved
Ribavirin
FDA approved

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,678 Previous Clinical Trials
4,125,133 Total Patients Enrolled
108 Trials studying Hepatitis C
47,402 Patients Enrolled for Hepatitis C
~34 spots leftby Sep 2025
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