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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25591
• EU PAS number:
  EUPAS17875
• Study ID:
  25591
• Official title and acronym:
  A Long Term Follow-up Registry for Adolescent and Pediatric Subjects Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Belgium

  Germany

  Italy

  New Zealand

  Poland

  Russian Federation

  United Kingdom

  United States
• Study description:
  GS-US-334-1113: Gilead Sciences is developing a number of novel antiviral agents targeting various components of the hepatitis C virus replication cycle and the Registry Study provided long-term assessment of safety and durability in pediatric subjects. Given the concern of the effect of current standard of care treatments (PEG and RBV) may have on growth and development in the pediatric population, the registry study specifically determined the effect of investigational anti-HCV regimens in the pediatric population as determined by assessments of growth and development. Lastly, the Registry was designed to provide long term clinical and virologic follow-up in subjects who have achieved SVR while participating in a previous Gilead-sponsored HCV study. This Registry also provided long-term follow-up to evaluate HCV viral sequences, and the persistence or evolution of viral mutations in subjects who did not achieve an SVR in a previous Gilead-sponsored chronic hepatitis C trial.
• Study status:
  Finalised

Research institution and networks

Institutions

Gilead Sciences

Multiple centres: 52 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 10/04/2015

Study start date

Actual: 21/10/2015

Date of final study report

Planned: 31/01/2025

Actual: 16/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences, Inc.

Study protocol

Initial protocol

GS-US-334-1113-appendix-16.1.1-protocol_f-redact

Updated protocol

GS-US-334-1113-appendix-16.1.1-protocol Amendment 3_f-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

EudraCT Number: 2014-004674-42 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-004674-42)ClinicalTrials.gov identification number: NCT02510300 (https://clinicaltrials.gov/ct2/show/NCT02510300?term=NCT02510300&rank=1)