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: 18.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 18.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-15
• Study Completion: 2021-12-31
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1609

Inclusion Criteria

1) Willing and able to provide written informed consent;
2) Have previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon;
3) Have achieved SVR in a Gilead-sponsored study, as defined in the treatment protocol;
4) Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen.
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 1700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the durability of SVR; To assess clinical progression or regression of liver disease, including the incidence of hepatocellular carcinoma (HCC) following SVR.;Secondary Objective: To determine whether subsequent detection of HCV RNA in subjects who relapse following SVR represents the re-emergence of pre-existing virus, the development of resistance mutations, or re-infection.<br><br>To assess quality of life following SVR.;Primary end point(s): To assess the durability of SVR;<br><br>To assess clinical progression or regression of liver disease, including the incidence of hepatocellular carcinoma (HCC) following SVR.;Timepoint(s) of evaluation of this end point: The proportion of subjects maintaining SVR at Week 240;<br><br>The proportion of subjects who develop liver disease progression or regression, as assessed by clinical and laboratory parameters throughout the study;<br><br>The proportion of subjects who develop HCC through Week 240.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To determine whether subsequent detection of HCV RNA in subjects who relapse following SVR represents the re-emergence of pre-existing virus, the development of resistance mutations, or re-infection.;Timepoint(s) of evaluation of this end point: The proportion of subjects with detectable HCV RNA due to re-emergence of pre-existing virus through Week 240;<br><br>The proportion of subjects with detectable HCV resistance mutations through Week 240.<br><br>The proportion of subjects with detectable HCV RNA due to re-infection through Week 240.