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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01448044
First received: October 5, 2011
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Hepatitis C
Drug: BMS-790052 (NS5A Replication Complex Inhibitor)
Drug: Placebo matching BMS-790052
Drug: Pegylated-interferon alfa 2a
Drug: Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Compare rates of Sustained Virologic Response (SVR12) for Hepatitis C virus (HCV) Genotype 4 subjects treated with either BMS-790052 or placebo in combination with pegIFNα-2a/RBV [ Time Frame: Week 12 follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects who achieve HCV Ribonucleic acid (RNA) < Limit of quantification (LOQ) [ Time Frame: Weeks 1, 2, 4, 6, 8 and 12; at both weeks 4 and 12 VR (4 & 12); EOT (up to 48 weeks); post-treatment week 24 (SVR24); or post-treatment Week 48 for subjects who achieve VR(4&12) defined as HCV RNA undetectable at weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve HCV RNA undetectable [ Time Frame: Weeks 1, 2, 4, 6, 8, and 12; at both weeks 4 and 12 (VR4&12); EOT; post-treatment week 12; post-treatment week 24; or post-treatment Week 48 for subjects who achieve Virologic response at week 4 and week 12 [VR(4&12)] ] [ Designated as safety issue: No ]
  • Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) for each cohort on treatment [ Time Frame: Maximum of 48 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with SVR12 or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene [ Time Frame: Post-treatment week 12 and post treatment week 24 ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: December 2011
Study Completion Date: January 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 subjects < 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response
Drug: BMS-790052 (NS5A Replication Complex Inhibitor) Drug: Pegylated-interferon alfa 2a
Other Name: Pegasys
Drug: Ribavirin
Other Name: Copegus
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 subjects < 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks
Drug: Placebo matching BMS-790052 Drug: Pegylated-interferon alfa 2a
Other Name: Pegasys
Drug: Ribavirin
Other Name: Copegus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects 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. Subjects 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448044

Locations
United States, California
Scti Research Foundation
San Clemente, California, United States, 92673
United States, Massachusetts
Umass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Rhode Island
University Gastroenterology
Providence, Rhode Island, United States, 02905
United States, Virginia
Metropolitan Research
Annandale, Virginia, United States, 22003
France
Local Institution
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
Greece
Local Institution
Thesaloniki, Greece, 54639
Italy
Local Institution
Roma, Italy, 00149
Local Institution
Torino, Italy, 10126
Mexico
Local Institution
Df, Distrito Federal, Mexico, 06700
Puerto Rico
Local Institution
San Juan, Puerto Rico, 00927
Spain
Local Institution
A Coruna, Spain, 15706
Local Institution
Barcelona, Spain, 08003
Local Institution
Barcelona, Spain, 08035
Local Institution
Madrid, Spain, 28046
United Kingdom
Local Institution
London, Greater London, United Kingdom, SE5 9RS
Local Institution
London, Greater London, United Kingdom, W2 1NY
Local Institution
London, Greater London, United Kingdom, SW17 0QT
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01448044     History of Changes
Other Study ID Numbers: AI444-042, 2011-002793-23
Study First Received: October 5, 2011
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:
hepatitis C virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014