Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

September 11, 2015 updated by: Bristol-Myers Squibb

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bondy Cedex, France, 93143
        • Local Institution
      • Creteil, France, 94000
        • Local Institution
      • La Roche-Sur-Yon Cedex 9, France, 85925
        • Local Institution
      • Marseille Cedex 08, France, 13285
        • Local Institution
      • Nice Cedex 03, France, 06202
        • Local Institution
      • Orleans Cedex 2, France, 45067
        • Local Institution
      • Paris, France, 75013
        • Local Institution
      • Paris, France, 75475
        • Local Institution
      • Strasbourg Cedex, France, 67091
        • Local Institution
      • Toulouse Cedex 09, France, 31059
        • Local Institution
      • Villejuif, France, 94804
        • Local Institution
  • Greece
      • Thesaloniki, Greece, 54639
        • Local Institution
  • Italy
      • Roma, Italy, 00149
        • Local Institution
      • Torino, Italy, 10126
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution
  • Spain
      • A Coruna, Spain, 15706
        • Local Institution
      • Barcelona, Spain, 08035
        • Local Institution
      • Barcelona, Spain, 08003
        • Local Institution
      • Madrid, Spain, 28046
        • Local Institution
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • Local Institution
      • London, Greater London, United Kingdom, SW17 0QT
        • Local Institution
      • London, Greater London, United Kingdom, W2 1NY
        • Local Institution
  • United States
    • California
      • San Clemente, California, United States, 92673
        • Scti Research Foundation
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Metropolitan Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMS-790052 + PegIFNα-2a + Ribavirin
  • 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
Drug: Ribavirin
Other Names:
  • Copegus
Drug: BMS-790052 (NS5A Replication Complex Inhibitor)
Drug: Pegylated-interferon alfa 2a
Other Names:
  • Pegasys
Placebo Comparator: Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin
  • 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
Drug: Ribavirin
Other Names:
  • Copegus
Drug: Pegylated-interferon alfa 2a
Other Names:
  • Pegasys
Drug: Placebo matching BMS-790052

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12 (Follow-up period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Time Frame: 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
Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.
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
Time Frame: 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
Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.
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
Time Frame: Post Treatment Weeks 12, 24
Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively.
Post Treatment Weeks 12, 24
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died
Time Frame: From Day 1 (start of study treatment) up to Follow-up Week 4
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.
From Day 1 (start of study treatment) up to Follow-up Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

October 5, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 11, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI444-042
  • 2011-002793-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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