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
- Conditions
- Hepatitis C Virus InfectionMedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-000946-39-GB
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 567
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method