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Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C Virus

Intervention: BMS-650032 (Drug); BMS-650032 (Drug); Placebo (Drug); Placebo (Drug); Placebo (Drug); Peginterferon Alfa-2a (Drug); Peginterferon Alfa-2a (Drug); Ribavirin (Drug); Ribavirin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs

Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA

Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA

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

Secondary outcome:

Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4

Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only)

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)

Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12

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)

Resistant variants associated with virologic failure

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Local Institution, Buenos Aires C1181, Argentina

Local Institution, Creteil Cedex 94010, France

Local Institution, Marseille Cedex 08 13285, France

Local Instituition, Montpellier Cedex 5 34295, France

Local Institution, Paris Cedex 13 75651, France

Local Institution, Paris Cedex 14 75679, France

Local Institution, Vandoeuvre Les Nancy 54511, France

Local Institution, Frankfurt 60590, Germany

Local Institution, Heidelberg 69120, Germany

Local Institution, Mainz 55131, Germany

Local Institution, Wurzburg 97080, Germany

Local Institution, Dublin DUBLIN 7, Ireland

Local Institution, Torino 10126, Italy

Local Institution, Alicante 03010, Spain

Local Institution, Barcelona 08035, Spain

Local Institution, Madrid 28222, Spain

Local Institution, Malaga 29010, Spain

Local Institution, Valencia 46010, Spain

University Of Alabama At Birmingham, Birmingham, Alabama 35294-0006, United States

Alabama Liver & Digestive Specialists (Alds), Montgomery, Alabama 36116, United States

Local Institution, Ciudad De Buenos Aires, Buenos Aires C1121ABE, Argentina

Local Institution, Prov. Buenos Aires, Buenos Aires 1629, Argentina

Florida Hospital Transplant Center, Orlando, Florida 32804, United States

Local Institution, London, Greater London W2 1NY, United Kingdom

Local Institution, London, Greater London SE5 9RS, United Kingdom

Local Institution, London, Greater London E1 2AT, United Kingdom

Local Institution, Manchester, Greater Manchester M8 5RB, United Kingdom

Local Institution, Glasgow, Lanarkshire G12 0YN, United Kingdom

Mercy Medical Center, Baltimore, Maryland 21202, United States

The Research Institute, Springfield, Massachusetts 01105, United States

Umass Memorial Medical Center, Worcester, Massachusetts 01655, United States

James J Peters Vamc, Bronx, New York 10468, United States

University Of North Carolina, Chapel Hill, Chapel Hill, North Carolina 27599, United States

Healthcare Research Consultants, Tulsa, Oklahoma 74135-2920, United States

Oregon Health Science Univ, Portland, Oregon 97239, United States

Hospital Of The University Of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Local Institution, Prov De Santa Fe, Santa Fe 2000, Argentina

Gastro One, Germantown, Tennessee 38138, United States

Metropolitan Research, Fairfax, Virginia 22031, United States

Dean Clinic, Madison, Wisconsin 53715, United States

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: February 2010
Last updated: June 20, 2013

Page last updated: August 23, 2015

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