Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial

Phase 1

• Conditions: Chronic Hepatitis C; MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005287-21-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-30
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

1. Received at least one dose of asunaprevir and/or daclatasvir and
completed participation in a previous study
a) Subjects participating in daclatasvir and/or asunaprevir studies may enroll regardless of virologic response (subjects who received control agents, eg, placebo, will be allowed to participate until unblinded treatment information is released for the parent protocol; at that time subjects will have the option to continue in the study)
2. Enrolled within 6 months of completing previous study or within 6 months of protocol availability at the clinical site
Are the trial subjects under 18? no
Number of subjects for this age range:
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

1. Treatment with any antiviral or immunomodulatory drug for hepatitis C after completion of the previous study

Study & Design

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