Chronic Hepatitis C Virus Genotype 1 Clinical Trial
Official title:
A Randomized, Placebo-controlled, Phase 2a Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I
| Verified date | March 2011 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Treatment-naive subjects with genotype 1 chronic HCV - HCV RNA = 100,000 IU/mL at screening - Seronegative for HIV and HBsAg - Liver biopsy within prior 2 years demonstrating no cirrhosis Exclusion Criteria: - Any evidence of liver disease other than hepatitis C - Diagnosed or suspected hepatocellular carcinoma - Laboratory values: neutrophil count < 1500 cells/µL, platelet count < 90,000/µL; Hemoglobin = 12 g/dL (120g/L) for women and = 13 g/dL (130 g/L) for men - Cirrhosis |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Bach And Godofsky Infectious Diseases | Bradenton | Florida |
| United States | Local Institution | Coronado | California |
| United States | Baylor University Medical Center | Dallas | Texas |
| United States | Maryland Digestive Disease Research | Laurel | Maryland |
| United States | Gastrointestinal Specialists Of Georgia Pc | Mareitta | Georgia |
| United States | Liver Institute Of Virginia Bon Secours Health System | Newport News | Virginia |
| United States | Orlando Immunology Center | Orlando | Florida |
| United States | Local Institution | Philadelphia | Pennsylvania |
| United States | Research And Education, Inc. | San Diego | California |
| United States | Vita Medical Center & Research Solutions, Inc. | Tamarac | Florida |
| United States | Washington Hospital Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Week 4 | Yes | |
| Primary | Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Week 12 | Yes | |
| Primary | Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Week 24 | Yes | |
| Primary | Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Week 48 | Yes | |
| Primary | Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA | Week 4 | Yes | |
| Primary | Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA | Week 12 | Yes | |
| Secondary | Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA | Week 4 | No | |
| Secondary | Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA | Week 12 | No | |
| Secondary | Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable | Week 12 (SVR12) | No | |
| Secondary | Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable | Week 24 (SVR24) | No | |
| Secondary | Resistant variants associated with virologic failure | Week 4 | No | |
| Secondary | Resistant variants associated with virologic failure | Week 12 | No | |
| Secondary | Resistant variants associated with virologic failure | Follow up Week 12 | No | |
| Secondary | Resistant variants associated with virologic failure | Week 24 | No |