A long-term study to follow patients infected with chronic Hepatitis C who achieved a cure following treatment in a Gilead clinical trial.
- Conditions
- Genotype 1 Hepatitis C Virus InfectionMedDRA version: 14.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-000945-19-FR
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 6607
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;<br> 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;<br> <br> To assess clinical progression of liver disease;<br> <br> To screen for the development of hepatocellular carcinoma (HCC).<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): None. This is a registry study.;Timepoint(s) of evaluation of this end point: n/a