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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: September 11, 2015
Last verified: September 2015
  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:
  • Percentage of Participants With 12 Week Sustained Virologic Response (SVR12) [ Time Frame: Week 12 (Follow-up period) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 152
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 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: 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 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: 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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
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, SW17 0QT
Local Institution
London, Greater London, United Kingdom, W2 1NY
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
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
Results First Received: August 7, 2015
Last Updated: September 11, 2015
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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016