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Clinical Trials/NCT01616524
NCT01616524
Completed
Phase 3

A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects

Bristol-Myers Squibb19 sites in 2 countries880 target enrollmentStarted: July 2012Last updated:
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ConditionsHepatitis C Virus (HCV)
InterventionsPegylated interferon lambda (pegIFNλ)RibavirinPlacebo matching DaclatasvirDaclatasvirPegylated interferon alfa-2a (pegIFNα-2a)
DrugsRibavirinDaclatasvirPlacebo matching Daclatasvir

Overview

Phase
Phase 3
Status
Completed
Enrollment
880
Locations
19
Primary Endpoint
Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Chronic hepatitis C, Genotype 2 or 3
  • •Naïve to prior anti-HCV therapy

Exclusion Criteria

  • •Infected with HCV other than Genotype 2 or 3
  • •Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
  • •Evidence of liver disease other than HCV
  • •Active substance abuse
  • •Evidence of decompensated cirrhosis

Arms & Interventions

Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir

Experimental

Intervention: Pegylated interferon lambda (pegIFNλ) (Biological)

Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir

Experimental

Intervention: Ribavirin (Drug)

Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir

Experimental

Intervention: Placebo matching Daclatasvir (Drug)

Arm 2: pegIFNλ + Ribavirin + Daclatasvir

Experimental

Intervention: Pegylated interferon lambda (pegIFNλ) (Biological)

Arm 2: pegIFNλ + Ribavirin + Daclatasvir

Experimental

Intervention: Ribavirin (Drug)

Arm 2: pegIFNλ + Ribavirin + Daclatasvir

Experimental

Intervention: Daclatasvir (Drug)

Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir

Experimental

Intervention: Pegylated interferon alfa-2a (pegIFNα-2a) (Biological)

Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir

Experimental

Intervention: Ribavirin (Drug)

Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir

Experimental

Intervention: Placebo matching Daclatasvir (Drug)

Outcomes

Primary Outcomes

Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)

Time Frame: Post-treatment follow-up week 12

Secondary Outcomes

  • Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3)(Up to week 12 or week 24)
  • Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection(Post-treatment follow-up week 12)
  • Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)(Up to week 12 or week 24)
  • Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group(Post-treatment week 24)
  • Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)](On-treatment Week 4)
  • Proportion of subjects with on-treatment Serious adverse events (SAEs)(Up to week 12 or week 24)
  • Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia)(Up to week 12 or week 24)
  • Proportion of subjects who discontinue due to Adverse events (AEs)(Up to week 12 or week 24)
  • Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain)(Up to week 12 or week 24)
  • Proportion of subjects with dose reductions(Up to week 12 or week 24)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (19)

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