Safety and Efficacy of BMS-790052 Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01017575
First received: November 19, 2009
Last updated: November 29, 2011
Last verified: June 2010
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Purpose
The purpose of this study is to identify at least 1 dose of BMS-790052, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C Infection |
Drug: BMS-790052 Drug: Placebo Drug: Peginterferon alfa-2a Drug: Ribavirin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Safety and tolerability, as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
- Safety and tolerability, as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
- Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA from baseline [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
- Proportions of subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
- Proportions of subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
- Resistant variants associated with virologic failure [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
- Resistant variants associated with virologic failure [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
- Resistant variants associated with virologic failure [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
| Enrollment: | 43 |
| Study Start Date: | December 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A (BMS-790052, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
|
Drug: BMS-790052
Tablets, Oral, 10 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Copegus®
|
|
Experimental: Arm B (BMS-790052, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
|
Drug: BMS-790052
Tablets, Oral, 60 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Copegus®
|
|
Placebo Comparator: Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
|
Drug: Placebo
Tablets, Oral, 0 mg, daily, 48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Copegus®
|
|
Experimental: Arm D (BMS-790052, plus peginterferon alfa-2a, Ribavirin)
Non-Responder
|
Drug: BMS-790052
Tablets, Oral, 10 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Copegus®
|
|
Experimental: Arm E (BMS-790052, plus Peginterferon alfa-2a, Ribavirin)
Non-Responder
|
Drug: BMS-790052
Tablets, Oral, 60 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Copegus®
|
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects chronically infected with HCV genotype 1
- HCV RNA viral load ≥ 10*5* IU/mL (100,000 IU/mL) at screening
- The current standard of care naïve or non-responder
Exclusion Criteria:
- Cirrhosis
- HCC
- Co-infection with HBV, HIV-1 or HIV-2
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017575
Locations
| Japan | |
| Local Institution | |
| Chiba-Shi, Chiba, Japan | |
| Local Institution | |
| Kurume-Shi, Fukuoka, Japan, 8300011 | |
| Local Institution | |
| Okayama-Shi, Okayama, Japan, 7008558 | |
| Local Institution | |
| Osaka-Shi, Osaka, Japan, 545-8586 | |
| Local Institution | |
| Osaka-Shi, Osaka, Japan, 5438555 | |
| Local Institution | |
| Musashino-Shi, Tokyo, Japan, 180-0023 | |
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: | NCT01017575 History of Changes |
| Other Study ID Numbers: | AI444-022 |
| Study First Received: | November 19, 2009 |
| Last Updated: | November 29, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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 |
Interferon-alpha Ribavirin Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013