A long term follow-up study of chronic hepatitis C patients treated with alisporivir to assess durability of sustained virologic response

• Conditions: Chronic hepatitis C in patients who achieved sustained virologic response (SVR24) on alisporivir in a Novartis-sponsored chronic Hepatitis C study.; MedDRA version: 16.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-006131-38-HU
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-13
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

-Written informed consent must be obtained before any assessment is performed
-Males or females must be aged 18 years or older
-Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir
-Have achieved SVR24
-Be able to comply with visit schedule
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 650
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer
-Use or planned use to start a new course of hepatitis C therapy

Study & Design

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