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

A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead Sponsored Trials in Subjects with Chronic Hepatitis C Infection

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000945-19-FR

Enrollment

740

Registered

2011-09-02

Start date

2012-01-23

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genotype 1 Hepatitis C Virus Infection MedDRA version: 14.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Code: GS-5885 Pharmaceutical Form: Film-coated tablet Current Sponsor code: GS-5885 Other descriptive name: GS-5885 Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Willing and able to provide written informed consent; 2. Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead OAV; 3. Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol; 4. Be willing and able to comply with the visit schedule and protocol-mandated procedures. 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 666 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 74

Exclusion criteria

Exclusion criteria: 1. Subject plans to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry. 2. History of clinically-significant illness or any other major medical disorder that may interfere with subject follow-up, assessments or compliance with the protocol.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): None. This is a registry study;Timepoint(s) of evaluation of this end point: n/a;Main Objective: To assess the durability of sustained virologic response (SVR) following treatment in a Gilead-sponsored Hepatitis C Study; 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 whether it is due to re-infection; To assess clinical progression of liver disease; To screen for the development of hepatocellular carcinoma (HCC).	—

Measure

Time frame

Primary end point(s): None. This is a registry study;Timepoint(s) of evaluation of this end point: n/a;Main Objective: To assess the durability of sustained virologic response (SVR) following treatment in a Gilead-sponsored Hepatitis C Study; 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 whether it is due to re-infection; To assess clinical progression of liver disease; To screen for the development of hepatocellular carcinoma (HCC).

—

Secondary

Measure	Time frame
Secondary end point(s): None. This is a registry study.;Timepoint(s) of evaluation of this end point: n/a	—

Countries

Australia, Austria, Belgium, Canada, Czech Republic, Estonia, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactMedical Monitor

Gilead Sciences Inc

clinical.trials@gilead.com+1650574-3000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026