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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

NCT02510300 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 461

Last updated 2023-01-27

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis C Virus Infection

Interventions

DRUG

Sofosbuvir (SOF)

Exposure of interest for participants who received a SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials

DRUG

Ledipasvir/Sofosbuvir (LDV/SOF)

Exposure of interest for participants who received a LDV/SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials

DRUG

Sofosbuvir/Velpatasvir (SOF/VEL)

Exposure of interest for participants who received a SOF/VEL-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials

DRUG

Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX)

Exposure of interest for participants who received a SOF/VEL/VOX-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-21
Primary Completion
2023-01-06
Completion
2023-01-06

Countries

  • United States
  • Australia
  • Belgium
  • Germany
  • Italy
  • New Zealand
  • Poland
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02510300 on ClinicalTrials.gov