ong-Term Follow-Up of Subjects in a Phase 1, 2, or 3 CLinical Trial in Which Boceprevir or Narlaprevir was Administered for the Treatment of Chronic Hepatitis C

• Conditions: ong-term Follow-up of prior study participants; MedDRA version: 14.1Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders

• Registration Number: EUCTR2006-006529-25-PT
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-22
• Last Update Posted: 21 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2800

Inclusion Criteria

-Subject must be willing to give written informed consent.
-Subject must have received at least one dose of any study medication
(peginterferon, ribavirin, boceprevir or narlaprevir) in a previous SPRI Phase
1, 2, or 3 clinical study in which boceprevir or narlaprevir was administered.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Concurrent participation in any other clinical study for the treatment of chronic
hepatitis C.
-Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C
after completion of, or discontinuation from, the SPRI Phase 1, 2, or 3 clinical
study in which the subject previously participated.
-Any condition which in the opinion of the Investigator would make the subject
unsuitable for enrollment.

Study & Design

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