A 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
This study has been withdrawn prior to enrollment.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01142700
First received: June 3, 2010
Last updated: March 14, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C Virus Genotype 1 |
Drug: BMS-824393 Drug: Placebo Drug: Peginterferon Alpha-2a Drug: Ribavirin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
- Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
- Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
- Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
- Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
- Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable [ Time Frame: Week 12 (SVR12) ] [ Designated as safety issue: No ]
- Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable [ Time Frame: Week 24 (SVR24) ] [ Designated as safety issue: No ]
- Resistant variants associated with virologic failure [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- Resistant variants associated with virologic failure [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Resistant variants associated with virologic failure [ Time Frame: Follow up Week 12 ] [ Designated as safety issue: No ]
- Resistant variants associated with virologic failure [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BMS-824393 (10mg)
Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 |
Drug: BMS-824393
Capsule, Oral, 10 mg, once daily
Drug: Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Other Name: Copegus
|
|
Experimental: BMS-824393 (30 mg)
Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 |
Drug: BMS-824393
Capsule, Oral, 30 mg, once daily
Drug: Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Other Name: Copegus
|
|
Experimental: BMS-824393 (100 mg)
Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 |
Drug: BMS-824393
Capsule, Oral, 100 mg, once daily
Drug: Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Other Name: Copegus
|
|
Placebo Comparator: Placebo
Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12 |
Drug: Placebo
Capsule, Oral, 0 mg, once daily
Drug: Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Other Name: Copegus
|
|
Peginterferon alfa-2a plus Ribavirin
Weeks 13 - 48
|
Drug: Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Other Name: Copegus
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142700
Locations
| United States, California | |
| Local Institution | |
| Coronado, California, United States, 92118 | |
| Research And Education, Inc. | |
| San Diego, California, United States, 92105 | |
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Bach And Godofsky Infectious Diseases | |
| Bradenton, Florida, United States, 34209 | |
| Orlando Immunology Center | |
| Orlando, Florida, United States, 32803 | |
| Vita Medical Center & Research Solutions, Inc. | |
| Tamarac, Florida, United States, 33319 | |
| United States, Georgia | |
| Gastrointestinal Specialists Of Georgia Pc | |
| Mareitta, Georgia, United States, 30060 | |
| United States, Maryland | |
| Maryland Digestive Disease Research | |
| Laurel, Maryland, United States, 20707 | |
| United States, Pennsylvania | |
| Local Institution | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| United States, Virginia | |
| Liver Institute Of Virginia Bon Secours Health System | |
| Newport News, Virginia, United States, 23602 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01142700 History of Changes |
| Other Study ID Numbers: | AI451-004, 2010-018702-36 |
| Study First Received: | June 3, 2010 |
| Last Updated: | March 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Virus Diseases Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Ribavirin Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013