Hepatitis C Clinical Trial
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
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).
Status | Completed |
Enrollment | 152 |
Est. completion date | January 2014 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Local Institution | Bondy Cedex | |
France | Local Institution | Creteil | |
France | Local Institution | La Roche-Sur-Yon Cedex 9 | |
France | Local Institution | Marseille Cedex 08 | |
France | Local Institution | Nice Cedex 03 | |
France | Local Institution | Orleans Cedex 2 | |
France | Local Institution | Paris | |
France | Local Institution | Paris | |
France | Local Institution | Strasbourg Cedex | |
France | Local Institution | Toulouse Cedex 09 | |
France | Local Institution | Villejuif | |
Greece | Local Institution | Thesaloniki | |
Italy | Local Institution | Roma | |
Italy | Local Institution | Torino | |
Puerto Rico | Local Institution | San Juan | |
Spain | Local Institution | A Coruna | |
Spain | Local Institution | Barcelona | |
Spain | Local Institution | Barcelona | |
Spain | Local Institution | Madrid | |
United Kingdom | Local Institution | London | Greater London |
United Kingdom | Local Institution | London | Greater London |
United Kingdom | Local Institution | London | Greater London |
United States | Metropolitan Research | Annandale | Virginia |
United States | University Gastroenterology | Providence | Rhode Island |
United States | Scti Research Foundation | San Clemente | California |
United States | Umass Memorial Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, France, Greece, Italy, Puerto Rico, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Secondary | Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | 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 | No |
Secondary | Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | 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 | No |
Secondary | 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 | 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 | No |
Secondary | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died | 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 | Yes |
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