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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02510300
Recruitment Status : Terminated (The study stopped early because the study objectives were met.)
First Posted : July 29, 2015
Last Update Posted : January 27, 2023
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Hepatitis C Virus Infection Drug: Sofosbuvir (SOF) Drug: Ledipasvir/Sofosbuvir (LDV/SOF) Drug: Sofosbuvir/Velpatasvir (SOF/VEL) Drug: Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX)

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 461 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: 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
Actual Study Start Date : October 21, 2015
Actual Primary Completion Date : January 6, 2023
Actual Study Completion Date : January 6, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Sofosbuvir (SOF)
    Exposure of interest for participants who received a SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
    Other Names:
    • Sovaldi®
    • GS-7977
    • PSI-7977
  • 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
    Other Names:
    • Harvoni®
    • GS-5885/GS-7977
  • 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
    Other Names:
    • Epclusa®
    • GS-7977/GS-5816
  • 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
    Other Names:
    • Vosevi®
    • GS-7977/GS-5816/GS-9857

Outcome Measures
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Primary Outcome Measures :
  1. Growth data as measured by body height [ Time Frame: Up to 5 years ]
  2. Growth data as measured by body weight [ Time Frame: Up to 5 years ]
  3. Development as measured by Tanner Pubertal Stage Assessment [ Time Frame: Up to 5 years ]

Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals who 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 (DAA)
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510300


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Additional Information:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02510300    
Other Study ID Numbers: GS-US-334-1113
2014-004674-42 ( EudraCT Number )
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: January 27, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gileadclinicaltrials.com/transparency-policy/
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Flaviviridae Infections
Hepatitis, Chronic
Sofosbuvir
Ledipasvir, sofosbuvir drug combination
Sofosbuvir-velpatasvir drug combination
Ledipasvir
Velpatasvir
Antiviral Agents
Anti-Infective Agents