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Antiviral

Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin for Hepatitis C

Phase 3
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 weeks 1, 2, 4, 6, 8, 12; both weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment weeks 12 and 24
Awards & highlights

Summary

The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.

Eligible Conditions
  • Hepatitis C

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, 4, 6, 8, 12; both weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment weeks 12 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 4, 6, 8, 12; both weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment weeks 12 and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)
Secondary study objectives
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died
Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene
Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + RibavirinExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribavirin
FDA approved
Daclatasvir
FDA approved
Peginterferon alfa-2a
FDA approved

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,680 Previous Clinical Trials
4,124,981 Total Patients Enrolled
108 Trials studying Hepatitis C
47,466 Patients Enrolled for Hepatitis C
~32 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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