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-DE

Enrollment

6625

Registered

2011-07-08

Start date

2011-11-21

Completion date

Unknown

Last updated

2019-01-07

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

Conditions

Hepatitis C Virus Infection MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Ledipasvir Product Code: GS-5885 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ledipasvir Current Sponsor code: GS-5885 Concentration unit: mg milligram(s) Concentration t

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 5900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 725

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
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). ;Primary end point(s): None. This is an observational study.;Timepoint(s) of evaluation of this end point: n/a	—

Measure

Time frame

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). ;Primary end point(s): None. This is an observational study.;Timepoint(s) of evaluation of this end point: n/a

—

Secondary

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

Countries

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

Contacts

Public ContactClinical Trials Mailbox

Gilead Sciences International Ltd.

clinical.trials@gilead.com+441223897284

Outcome results

None listed

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