A long-term study to follow cirrhotic patients infected with chronic Hepatitis C who achieved a cure following treatment in a Gilead clinical trial.

Phase 1

• Conditions: Hepatitis C Virus Infection; MedDRA version: 20.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-001249-26-DE
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-27
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

1) Willing and able to provide written informed consent;
2) Have either previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon; OR At pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical study. These subjects must have documentation of the regimen, start and end of treatment dates (month and year), and of
having achieved SVR12
3) Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment protocol; OR for subjects who enroll after receiving an alloral SOF-based regimen outside a clinical study, SVR will be defined as HCV RNA < LLOQ approximately 12 weeks following last dose of treatment.
4) Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen; OR Subjects who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis as diagnosed prior to initiation of HCV Treatment.
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 1296
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 311

Exclusion Criteria

1) Subject plans to initiate a new course of HCV therapy, including approved products and any
investigational agents, during the course of this Registry;
2) History of clinically-significant illness or any other major medical disorder that may interfere
with the subject follow-up, assessments or compliance with the protocol.

Study & Design

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