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Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Participants in Some Hepatitis C Virus (HCV) Trials

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: Daclatasvir (Drug); Asunaprevir (Drug); Peginterferon alfa-2a (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 provide anti-HCV drugs to +/- 200 subjects treated in prior BMS studies with placebo + Peginterferon Alfa-2a and Ribavirin and determine if the addition of these drugs can result in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b subjects rolling over from BMS study AI447-028 who received placebo will be treated with active drugs in this study.

Clinical Details

Official title: An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy based on the proportion of subjects with Sustained virologic response (SVR)12 [HCV Ribonucleic acid (RNA) < LOQ at Follow-up week 12] for all subjects infected with genotype 1 who are prior non-responders to Peginterferon Alfa-2a/Ribavirin

Secondary outcome:

Efficacy as determined by the proportion of subjects with SVR12 in genotype 2, 3 & 4 prior non-responders to pegIFNα-2a/RBV and treatment naive genotype 1b

Safety measured by frequency of Serious Adverse Event(s) (SAE)s and discontinuations due to Adverse Events (AEs)

Proportion of subjects who achieve HCV RNA < Limit of quantitation (LOQ) (detectable or undetectable) for each HCV genotype and treatment regimen

Proportion of subjects who achieve HCV RNA undetectable for each HCV genotype and treatment regimen

Drug-resistant variants associated with virologic failure for each HCV genotype and treatment regimen

Detailed description:

- Intervention Model:

- Parallel: for all subjects entering the trial

- Cross-over: for genotype 1b subjects rolling over from AI447-028 who require

rescue therapy after initial treatment in this study

- Peginterferon Alfa-2a (pegIFNα-2a)

- Ribavirin (RBV)

- Daclatasvir (DCV)

- Asunaprevir (ASV)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Prior participation in any BMS-790052, BMS-650032, BMS-791325 trial and assigned to

control arm (Peginterferon α/Ribavirin + Placebo) during the trial

- HCV genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)

- HCV RNA viral load detectable

Exclusion Criteria:

- Discontinuation from prior BMS HCV clinical trial due to a

Peginterferon/Ribavirin-related event

- Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052 or

BMS-791325

- Positive for Hepatitis B infection (Hepatitis B surface antigen (HBsAg)) or Human

immunodeficiency virus 1 (HIV-1)/HIV-2 antibody at screening

- Evidence of medical condition associated with chronic liver disease other than HCV

- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Locations and Contacts

Local Institution, Buenos Aires 1119, Argentina

Local Institution, Graz 8036, Austria

Local Institution, Wien 1090, Austria

Local Institution, Quebec G3K 2P8, Canada

Local Institution, Hvidovre 2650, Denmark

Local Institution, Bondy Cedex 93143, France

Local Institution, Clichy Cedex 92118, France

Local Institution, Creteil 94000, France

Local Institution, Creteil 94010, France

Local Institution, Lille 59037, France

Local Institution, Lyon Cedex 02 69288, France

Local Institution, Marseille Cedex 08 13285, France

Local Institution, Montpellier Cedex 5 34295, France

Local Institution, Nice Cedex 03 06202, France

Local Institution, Paris Cedex 12 75571, France

Local Institution, Paris Cedex 13 75651, France

Local Institution, Paris Cedex 14 75679, France

Local Institution, Toulouse Cedex 09 31059, France

Local Institution, Toulouse 31059, France

Local Institution, Vandoeuvre Cedex 54511, France

Local Institution, Villejuif Cedex 94804, France

Local Institution, Berlin 12157, Germany

Local Institution, Berlin 13353, Germany

Local Institution, Bonn 53105, Germany

Local Institution, Frankfurt 60590, Germany

Local Institution, Hamburg 20246, Germany

Local Institution, Hannover 30625, Germany

Local Institution, Heidelberg 69120, Germany

Local Institution, Thesaloniki 54639, Greece

Local Institution, Dublin DUBLIN 7, Ireland

Local Institution, Brescia 25123, Italy

Local Institution, Cisanello (pisa) 56124, Italy

Local Institution, Messina 98124, Italy

Local Institution, Milano 20121, Italy

Local Institution, Pavia 27100, Italy

Local Institution, Roma 00149, Italy

Local Institution, Roma 00161, Italy

Local Institution, Torino 10126, Italy

Local Institution, Viale Del Policlinico, 155 00161, Italy

Local Institution, Busan 614-735, Korea, Republic of

Local Institution, Busan 602-739, Korea, Republic of

Local Institution, Busan 602-715, Korea, Republic of

Local Institution, Daegu 700-721, Korea, Republic of

Local Institution, Daegu 705-703, Korea, Republic of

Local Institution, Gyeonggi-do 420-767, Korea, Republic of

Local Institution, Seoul 120-752, Korea, Republic of

Local Institution, Seoul 138-736, Korea, Republic of

Local Institution, Auckland 92024, New Zealand

Local Institution, Bialystok 15-540, Poland

Local Institution, Wroclaw 50-349, Poland

Local Institution, Barcelona 08036, Spain

Local Institution, Gothenburg SE-416 85, Sweden

Local Institution, Stockholm 141 86, Sweden

Local Institution, Taichung 402, Taiwan

Local Institution, Taichung 40447, Taiwan

Local Institution, Taipei 100, Taiwan

Local Institution, Taipei 112, Taiwan

Baptist Medical Center South, Montgomery, Alabama 36116, United States

Local Institution, Vancouver, British Columbia V6Z 2K5, Canada

Local Institution, Victoria, British Columbia V8V 3P9, Canada

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

Local Institution, Ciudad De Buenos Aires, Buenos Aires C1181ACH, Argentina

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

Scripps Clinic, La Jolla, California 92037, United States

Scpmg/ Kaiser Permanente Los Angeles Medical Center, Los Angeles, California 90027, United States

University Of Colorado Denver And Hospital, Aurora, Colorado 80045, United States

Yale University School Of Medicine, New Haven, Connecticut 06520, United States

Local Institution, Dublin 8, Dublin, Ireland

Uf Hepatology Research At Ctrb, Gainesville, Florida 32610, United States

Schiff Center For Liver Diseases, Miami, Florida 33136, United States

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

Local Institution, London, Greater London SW17 0QT, United Kingdom

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

Local Institution, London, Greater London NW3 2QG,, United Kingdom

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

Local Institution, Guadalajara, Jalisco 44160, Mexico

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

Mercy Medical Center, Baltimore, Maryland 21202, United States

Digestive Disease Associates, P.A., Catonsville, Maryland 21228, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Washington University School Of Medicine, St. Louis, Missouri 63110, United States

Local Institution, Darlinghurst, New South Wales 2010, Australia

Local Institution, Kogarah, New South Wales 2218, Australia

Local Institution, Westmead Nsw, New South Wales 2145, Australia

North Shore Long Island Jewish Health System, Manhasset, New York 11030, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Options Health Research, Llc, Tulsa, Oklahoma 74104, United States

Local Institution, Toronto, Ontario M5G 2N2, Canada

Local Institution, Toronto, Ontario M5T 2S8, Canada

Local Institution, Toronto, Ontario M6H 3M1, Canada

Local Institution, Vaughan, Ontario L4L 4Y7, Canada

University Of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Local Institution, Montreal, Quebec H2L 4P9, Canada

Local Institution, Montreal, Quebec H3T 1E2, Canada

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

Local Institution, Adelaide, South Australia 5000, Australia

Nashville Medical Research Institute, Nashville, Tennessee 37205, United States

Baylor College Of Medicine, Houston, Texas 77030, United States

Alamo Medical Research, San Antonio, Texas 78215, United States

Local Institution, Clayton Vic, Victoria 3168, Australia

Local Institution, Fitzroy, Victoria 3065 VIC, Australia

Local Institution, Heidelberg, Victoria 3084, Australia

Local Institution, Melbourne, Victoria 3004, Australia

Metropolitan Research, Fairfax, Virginia 22031, United States

Local Institution, Fremantle, Western Australia 6160, Australia

Local Institution, Perth, Western Australia 6001, Australia

Dean Clinic, Madison, Wisconsin 53715, United States

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: September 2011
Last updated: February 6, 2015

Page last updated: August 23, 2015

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