Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Bristol-Myers Squibb.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01030432
First received: December 10, 2009
Last updated: June 18, 2012
Last verified: January 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C Virus |
Drug: BMS-650032 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/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs [ Time Frame: 12 weeks after first dose ] [ Designated as safety issue: Yes ]
- Antiviral activity as determined by proportion of HCV genotype 1 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 proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
- Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA [ Time Frame: at follow-up Week 24 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only) [ Time Frame: at Week 12 (Stage 2 only) ] [ Designated as safety issue: No ]
- Proportion of HCV genotype 1 subjects with early virologic response (EVR) defined as ≥2 log10 decrease in HCV RNA from baseline at Week 12 (Stage 1 only) [ Time Frame: Week 12 (Stage 1 only) ] [ Designated as safety issue: No ]
- Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12 [ Time Frame: follow-up Week 12 ] [ Designated as safety issue: No ]
- Proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) defined as undetectable HCV RNA at follow-up Week 24 (Stage 1 only) [ Time Frame: follow-up Week 24 (Stage 1 only) ] [ Designated as safety issue: No ]
- Resistant variants associated with virologic failure [ Time Frame: 48 weeks after last dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 348 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Phase 2a: Arm 1 |
Drug: BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 48 weeks
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Other Name: Copegus
|
| Placebo Comparator: Phase 2a: Arm 2 |
Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 48 weeks
Other Name: Pegasys
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Other Name: Copegus
|
| Experimental: Phase 2b: Arm 1 |
Drug: BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response
Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
Other Name: Pegasys
|
| Placebo Comparator: Phase 2b: Arm 2 |
Drug: Placebo
Tablets, Oral, 0 mg, twice daily 24 weeks
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
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:
- Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)
- Subjects chronically infected with HCV genotype 4 (Phase 2b only)
- HCV RNA viral load of ≥ 10*5* IU/mL at screening
- BMI of 18 - 35 kg/m² at screening
Exclusion Criteria:
- Cirrhosis (Phase 2a only)
- Decompensated cirrhosis (Phase 2b)
- Co-infection with HBV or HIV
- Hepatocellular carcinoma
- Prior treatment with anti-HCV drugs
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030432
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| University Of Alabama At Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| Alabama Liver & Digestive Specialists (Alds) | |
| Montgomery, Alabama, United States, 36116 | |
| United States, Florida | |
| Florida Hospital Transplant Center | |
| Orlando, Florida, United States, 32804 | |
| United States, Maryland | |
| Mercy Medical Center | |
| Baltimore, Maryland, United States, 21202 | |
| United States, Massachusetts | |
| The Research Institute | |
| Springfield, Massachusetts, United States, 01105 | |
| Umass Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, New York | |
| James J Peters Vamc | |
| Bronx, New York, United States, 10468 | |
| United States, North Carolina | |
| University Of North Carolina, Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Oklahoma | |
| Healthcare Research Consultants | |
| Tulsa, Oklahoma, United States, 74135 | |
| United States, Oregon | |
| Oregon Health Science Univ | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Hospital Of The University Of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Gastro One | |
| Germantown, Tennessee, United States, 38138 | |
| United States, Virginia | |
| Metropolitan Research | |
| Fairfax, Virginia, United States, 22031 | |
| United States, Wisconsin | |
| Dean Clinic | |
| Madison, Wisconsin, United States, 53715 | |
| Argentina | |
| Local Institution | |
| Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE | |
| Local Institution | |
| Prov. Buenos Aires, Buenos Aires, Argentina, 1629 | |
| Local Institution | |
| Prov De Santa Fe, Santa Fe, Argentina, 2000 | |
| Local Institution | |
| Buenos Aires, Argentina, C1181 | |
| France | |
| Local Institution | |
| Creteil Cedex, France, 94010 | |
| Local Institution | |
| Marseille Cedex 08, France, 13285 | |
| Local Institution | |
| Montpellier Cedex 5, France, 34295 | |
| Local Institution | |
| Paris Cedex 13, France, 75651 | |
| Local Institution | |
| Paris Cedex 14, France, 75679 | |
| Local Institution | |
| Vandoeuvre Les Nancy, France, 54511 | |
| Germany | |
| Local Institution | |
| Frankfurt, Germany, 60590 | |
| Local Institution | |
| Heidelberg, Germany, 69120 | |
| Local Institution | |
| Mainz, Germany, 55131 | |
| Local Institution | |
| Wurzburg, Germany, 97080 | |
| Ireland | |
| Local Institution | |
| Dublin, Ireland, DUBLIN 7 | |
| Italy | |
| Local Institution | |
| Torino, Italy, 10126 | |
| Spain | |
| Local Institution | |
| Alicante, Spain, 03010 | |
| Local Institution | |
| Barcelona, Spain, 08035 | |
| Local Institution | |
| Madrid, Spain, 28222 | |
| Local Institution | |
| Malaga, Spain, 29010 | |
| Local Institution | |
| Valencia, Spain, 46010 | |
| United Kingdom | |
| Local Institution | |
| London, Greater London, United Kingdom, SE5 9RS | |
| Local Institution | |
| London, Greater London, United Kingdom, W2 1NY | |
| Local Institution | |
| London, Greater London, United Kingdom, E1 2AT | |
| Local Institution | |
| Manchester, Greater Manchester, United Kingdom, M8 5RB | |
| Local Institution | |
| Glasgow, Lanarkshire, United Kingdom, G12 0YN | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01030432 History of Changes |
| Other Study ID Numbers: | AI447-016, 2009-013652-69 |
| Study First Received: | December 10, 2009 |
| Last Updated: | June 18, 2012 |
| Health Authority: | United States: Food and Drug Administration France: Ministry of Health Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory Agency Ireland: Irish Medicines Board Spain: Spanish Agency of Medicines Italy: The Italian Medicines Agency |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Hepatitis, Chronic 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 June 17, 2013