Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
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
2 other identifiers
interventional
152
7 countries
26
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2011
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
September 7, 2015
CompletedOctober 12, 2015
September 1, 2015
1.8 years
October 5, 2011
August 7, 2015
September 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)
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 Outcomes (4)
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
Study Arms (2)
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
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Scti Research Foundation
San Clemente, California, 92673, United States
Umass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Metropolitan Research
Annandale, Virginia, 22003, United States
Local Institution
Bondy, 93143, France
Local Institution
Créteil, 94000, France
Local Institution
La Roche-sur-Yon, 85925, France
Local Institution
Marseille, 13285, France
Local Institution
Nice, 06202, France
Local Institution
Orléans, 45067, France
Local Institution
Paris, 75013, France
Local Institution
Paris, 75475, France
Local Institution
Strasbourg, 67091, France
Local Institution
Toulouse, 31059, France
Local Institution
Villejuif, 94804, France
Local Institution
Thesaloniki, 54639, Greece
Local Institution
Roma, 00149, Italy
Local Institution
Torino, 10126, Italy
Local Institution
San Juan, 00927, Puerto Rico
Local Institution
A Coruña, 15706, Spain
Local Institution
Barcelona, 08003, Spain
Local Institution
Barcelona, 08035, Spain
Local Institution
Madrid, 28046, Spain
Local Institution
London, Greater London, SE5 9RS, United Kingdom
Local Institution
London, Greater London, SW17 0QT, United Kingdom
Local Institution
London, Greater London, W2 1NY, United Kingdom
Related Publications (1)
Hezode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourliere M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. Online ahead of print.
PMID: 26313445DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2011
First Posted
October 7, 2011
Study Start
December 1, 2011
Primary Completion
October 1, 2013
Study Completion
January 1, 2014
Last Updated
October 12, 2015
Results First Posted
September 7, 2015
Record last verified: 2015-09