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

Phase 1

• Conditions: Chronic Hepatitis C virus infection; MedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-004674-42-GB
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-26
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 560

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this Registry.
1. Have previously participated in a Gilead-sponsored chronic hepatitis C study as an adolescent or pediatric subject and received at least one Gilead HCV direct acting antiviral (DAA);
2. Parent or legal guardian able to provide written informed consent OR subject able to provide written informed consent and willing to comply with study requirements as determined by IRB/IEC/local requirements and Investigator’s discretion.
3. Subject able to provide written assent, if they have the ability to read and write, as determined by IRB/IEC/local requirements and Investigator’s discretion
Are the trial subjects under 18? yes
Number of subjects for this age range: 560
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following exclusion criteria are not to be enrolled in this Registry.
1. Subject is currently receiving or plans to initiate a new course of hepatitis C therapyincluding 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 interferewith the subject follow-up, assessments or compliance with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified