A clinical study with many of countries and sites participating. This study wants to look into the relationship of the genotype IL28B in patients from all over the world which are suffering from an inflammation of the liver with hepatitis C virus

Phase 1

• Conditions: Chronic hepatitis C; MedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-001096-39-SK
• Lead Sponsor: F.Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-30
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 4200

Inclusion Criteria

- Adult (according to local legislation) male or female
patients
- Chronic hepatitis C (CHC)
- Patients naïve to CHC treatment or patients who
received prior interferon (IFN) based therapy for CHC
for whom data on treatment received (type of therapy, dose, duration) and treatment outcome (i.e. rapid virological response [RVR], complete early virological response [cEVR], partial early virological response [pEVR], end of treatment response [EoT), sustained virological response [SVR], relapse, breakthrough, nonresponse) of prior therapy is available. In addition information on fibrosis stage prior to the previous treatment course is required.
- Written informed consent
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

- Co-infection with hepatitis B
- History or other evidence of decompensated liver
disease
- History of major organ transplantation with an existing functional graft (including liver transplantation)
- End stage renal disease

Study & Design

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