Three-year Follow-up Study of Subjects Who Participated in a Previous Lambda (BMS-914143) Chronic Hepatitis C Clinical Trial

NCT ID: NCT01525810

Last Updated: 2015-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-11-30

Brief Summary

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The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained virologic response

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects treated with Peginterferon Lambda-1a (BMS-914143)

Subjects who participated in a clinical trial in which Peginterferon Lambda-1a (BMS-914143) was administered for the treatment of chronic hepatitis C

Peginterferon Lambda-1a (BMS-914143)

Intervention Type DRUG

Observational study - No Intervention \[subjects were previously treated with Peginterferon Lambda-1a (BMS-914143)\]

Interventions

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Peginterferon Lambda-1a (BMS-914143)

Observational study - No Intervention \[subjects were previously treated with Peginterferon Lambda-1a (BMS-914143)\]

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have received Lambda in a previous trial and have Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< LOQ at the completion of the required post-treatment follow-up (must enter this study within 6 months of completion of the required post-treatment follow-up in the previous trial) NOTE: For blinded parent trials, subjects who have HCV RNA \<LOQ at the completion of the required post-treatment follow-up may enter this study without knowledge of their treatment assignment in the parent study. Subjects who received control agents (eg, pegylated-interferon alfa) in the previous protocol will be allowed to participate until unblinded treatment information is released; at that time subjects will have the option to continue in the study

Exclusion Criteria

* Subjects must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of the previous study of Lambda
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Scripps Clinic

La Jolla, California, United States

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Yale University School Of Medicine

New Haven, Connecticut, United States

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Orlando Immunology Center

Orlando, Florida, United States

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Gastrointestinal Specialists Of Georgia

Marietta, Georgia, United States

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The Queen'S Medical Center

Honolulu, Hawaii, United States

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Henry Ford Health System

Detroit, Michigan, United States

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Mayo Clinic

Rochester, Minnesota, United States

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Duke University Medical Center

Durham, North Carolina, United States

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Consultants For Clinical Research

Cincinnati, Ohio, United States

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Texas Clinical Research Institute

Arlington, Texas, United States

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St. Luke'S Episcopal Hospital - Baylor College Of Medicine

Houston, Texas, United States

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University Of Texas Health Science Center At Houston

Houston, Texas, United States

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Va Medical Center (151)

Houston, Texas, United States

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Texas Liver Institute

San Antonio, Texas, United States

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Clinical Research Centers Of America

Murray, Utah, United States

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Metropolitan Research

Annandale, Virginia, United States

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Virginia Mason Medical Center

Seattle, Washington, United States

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Local Institution

Buenos Aires, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Buenos Aires, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Camperdown, New South Wales, Australia

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Darlinghurst, New South Wales, Australia

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Randwick, New South Wales, Australia

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Sydney, New South Wales, Australia

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Westmead, New South Wales, Australia

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Greenslopes, Queensland, Australia

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Herston, Queensland, Australia

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Woolloongabba, Queensland, Australia

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Adelaide, South Australia, Australia

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Fitzroy, Victoria, Australia

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Heidelberg, Victoria, Australia

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Melbourne, Victoria, Australia

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Parkville, Victoria, Australia

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Vienna, , Austria

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Leuven, , Belgium

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Liège, , Belgium

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Toronto Digestive Disease Associates, Inc.

Vaughan, Ontario, Canada

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Hus, , Finland

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Clichy, , France

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Créteil, , France

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Montpellier, , France

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Nice, , France

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Paris, , France

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Paris, , France

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Pessac, , France

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Hamburg, , Germany

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Heidelberg, , Germany

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Athens, , Greece

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Thessaloniki, , Greece

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Cisanello (pisa), , Italy

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Florence, , Italy

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Milan, , Italy

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Milan, , Italy

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Napoli, , Italy

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Novara, , Italy

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Viale Del Policlinico, 155, , Italy

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Guadalajara, Jalisco, Mexico

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Amsterdam, , Netherlands

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Leiden, , Netherlands

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Auckland, , New Zealand

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Bialystok, , Poland

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Krakow, , Poland

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Wroclaw, , Poland

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San Juan, , Puerto Rico

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Bucharest, , Romania

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Bucharest, , Romania

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Iași, , Romania

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Timișoara, , Romania

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Busan, , South Korea

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Barcelona, , Spain

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Barcelona, , Spain

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Valencia, , Spain

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Countries

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United States Argentina Australia Austria Belgium Canada Finland France Germany Greece Italy Mexico Netherlands New Zealand Poland Puerto Rico Romania South Korea Spain

Related Links

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Other Identifiers

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2011-005293-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AI452-016

Identifier Type: -

Identifier Source: org_study_id

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