A 3-year follow-up study in chronic hepatitis C patients who failed to achieve sustained virologic response during Novartis-sponsored alisporivir studies

• Conditions: Chronic hepatitis C patients who failed to achieve sustained virologic response (SVR24) on alisporivir or direct-acting antivirals (DAA) in previous Novartis-sponsored studies.; MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-006132-24-HU
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-17
• Last Update Posted: 21 October 2013

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 aged 18 or greater
-Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent
-Have not acheived 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
-Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study

Study & Design

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