A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials

Gilead Sciences

Status: Terminated

Conditions: Hepatitis C Virus Infection

Treatments: Drug: Ledipasvir/Sofosbuvir (LDV/SOF); Drug: Sofosbuvir/Velpatasvir (SOF/VEL); Drug: Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX); Drug: Sofosbuvir (SOF)

Study type: Observational

Funder types: Industry

Identifiers

NCT02510300

GS-US-334-1113

2014-004674-42 (EudraCT Number)

Details and patient eligibility

About

This Registry will enroll adolescent and pediatric participants who received at least one Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a Gilead-sponsored chronic hepatitis C clinical trial. The primary objective of this Registry is to determine the long-term safety of anti-HCV regimens in the pediatric population. Secondary objectives of this Registry are to determine whether subsequent detection of HCV RNA in participants who relapse following sustained virologic response (SVR) represents the re-emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection, and to characterize resistance mutations and the persistence of resistance mutations in pediatric participants who did not achieve SVR. Once enrolled, participants will be followed for up to 5 years.

Enrollment: 461 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Have previously participated in a Gilead-sponsored chronic hepatitis C study as an adolescent or pediatric participant and received at least one Gilead HCV direct acting antiviral
• Parent or legal guardian able to provide written informed consent OR individual is able to provide written informed consent prior to any study procedures and willing to comply with study requirements as determined by institutional review board (IRB)/independent ethics committee(IEC)/local requirements and Investigator's discretion.
• Individual is 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

Key Exclusion Criteria:

• Individual is currently receiving or plans to initiate a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry.
• History of clinically-significant illness or any other major medical disorder that may interfere with the individual's follow-up, assessments or compliance with the protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.