TMC435HPC3002 - 3-Year Follow up of Patients After Administration of TMC435 for the Treatment of Chronic Hepatitis C.

Phase 1

• Conditions: Hepatitis C Virus (HCV); MedDRA version: 16.1Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-019843-20-DE
• Lead Sponsor: Janssen R&D Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-09
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Have previously participated in a Phase II or Phase III study; received at least one dose of TMC435 in that study; completed the last patient visit of the previous 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 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Currently enrolled or plan to enroll in another study with an investigational drug or invasive investigational medical device; received antiviral or immunomodulating treatment for HCV between last visit previous study and this study

Study & Design

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