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

• Conditions: Chronic Hepatitis C; MedDRA version: 15.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005293-31-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-09
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Subjects must have received Lambda in a previous trial and have HCV
RNA (must enter this study within 6 months of completion of the required
posttreatment follow-up in the previous trial) NOTE: For blinded parent
trials, subjects who have HCV RNA required posttreatment 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 960

Exclusion Criteria

Subjects must not have been treated with any antiviral or
immunomodulatory drug for hepatitis C after completion of treatment in
the previous study of Peginterferon Lambda- 1a (BMS-914143)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified