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Clinical Trials/NCT01492426
NCT01492426
Completed
Phase 3

A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

Bristol-Myers Squibb26 sites in 2 countries605 target enrollmentJanuary 2012
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ConditionsHepatitis C
InterventionsDaclatasvirPeginterferon alfa-2aRibavirinTelaprevir
DrugsDaclatasvirTelaprevirPeginterferon alfa-2aRibavirin

Overview

Phase
Phase 3
Intervention
Daclatasvir
Conditions
Hepatitis C
Sponsor
Bristol-Myers Squibb
Enrollment
605
Locations
26
Primary Endpoint
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

Detailed Description

Allocation: Randomized Stratified

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
March 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Participants chronically infected with hepatitis C virus (HCV) genotype 1a or 1b
  • •HCV RNA viral load ≥10,000 IU/mL
  • •No prior treatment including but not limited to interferon, ribavirin, and direct-acting antivirals
  • •No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
  • •Body mass index of 18 to 35 kg/m\^2
  • •Negative for HIV and hepatitis B virus

Exclusion Criteria

  • •Evidence of decompensated liver disease
  • •Evidence of medical condition other than HCV contributing to chronic liver disease

Arms & Interventions

Daclatasvir + Peginterferon alfa-2a + Ribavirin

Intervention: Daclatasvir

Daclatasvir + Peginterferon alfa-2a + Ribavirin

Intervention: Peginterferon alfa-2a

Daclatasvir + Peginterferon alfa-2a + Ribavirin

Intervention: Ribavirin

Telaprevir + Peginterferon alfa-2a + Ribavirin

Intervention: Telaprevir

Telaprevir + Peginterferon alfa-2a + Ribavirin

Intervention: Peginterferon alfa-2a

Telaprevir + Peginterferon alfa-2a + Ribavirin

Intervention: Ribavirin

Outcomes

Primary Outcomes

Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)

Time Frame: Week 12 (Follow-up period)

SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.

Secondary Outcomes

  • Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4(Week 4)
  • Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12(Week 4, Week 12)
  • Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)(Week 12 (Follow-up period))
  • Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)(Week 12)
  • Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)(Week 24 (Follow-up period))

Study Sites (26)

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