A long-term study to follow patients infected with chronic Hepatitis C who did not achieve a cure following treatment in a Gilead clinical trial

A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response 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

EUCTR2011-000946-39-DE

Enrollment

570

Registered

2011-07-08

Start date

2011-11-21

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

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 c

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 failed to achieve an SVR in that previous 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 535 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1. Subject is currently receiving or 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 an observational study.;Timepoint(s) of evaluation of this end point: n/a;Main Objective: To evaluate HCV viral sequences and the persistence of treatment emergent viral resistant mutations in subjects who fail to achieve SVR after treatment with an oral antiviral containing regimen in a Gileadsponsored Hepatitis C Study.; Secondary Objective: 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 an observational study.;Timepoint(s) of evaluation of this end point: n/a;Main Objective: To evaluate HCV viral sequences and the persistence of treatment emergent viral resistant mutations in subjects who fail to achieve SVR after treatment with an oral antiviral containing regimen in a Gileadsponsored Hepatitis C Study.; Secondary Objective: 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 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