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Clinical Trials/NCT01448044
NCT01448044CompletedPhase 3

A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4

Bristol-Myers Squibb5 sites in 2 countries152 target enrollmentStarted: December 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
152
Locations
5
Primary Endpoint
Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

Study Design

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

Eligibility Criteria

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

Inclusion Criteria

  • •Participants chronically infected with HCV Genotype 4
  • •HCV RNA viral load of ≥ 10,000 IU/mL
  • •No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent
  • •Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted

Exclusion Criteria

  • •Evidence of decompensated liver disease
  • •Documented or suspected Hepatocellular carcinoma (HCC)
  • •Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening

Arms & Interventions

BMS-790052 + PegIFNα-2a + Ribavirin

Experimental
  • BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks
  • PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response
  • Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response

Intervention: BMS-790052 (NS5A Replication Complex Inhibitor) (Drug)

BMS-790052 + PegIFNα-2a + Ribavirin

Experimental
  • BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks
  • PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response
  • Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response

Intervention: Pegylated-interferon alfa 2a (Drug)

BMS-790052 + PegIFNα-2a + Ribavirin

Experimental
  • BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks
  • PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response
  • Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response

Intervention: Ribavirin (Drug)

Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin

Placebo Comparator
  • Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks
  • PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks
  • Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks

Intervention: Placebo matching BMS-790052 (Drug)

Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin

Placebo Comparator
  • Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks
  • PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks
  • Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks

Intervention: Pegylated-interferon alfa 2a (Drug)

Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin

Placebo Comparator
  • Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks
  • PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks
  • Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks

Intervention: Ribavirin (Drug)

Outcomes

Primary Outcomes

Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)

Time Frame: Week 12 (Follow-up period)

Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels \< lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.

Secondary Outcomes

  • Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)(Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48)
  • Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels(Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48)
  • Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene(Post Treatment Weeks 12, 24)
  • Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died(From Day 1 (start of study treatment) up to Follow-up Week 4)

Investigators

Sponsor
Bristol-Myers Squibb
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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