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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

Tracking Information
First Submitted Date July 27, 2015
First Posted Date July 29, 2015
Last Update Posted Date January 27, 2023
Actual Study Start Date October 21, 2015
Actual Primary Completion Date January 6, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 21, 2016)
  • Growth data as measured by body height [ Time Frame: Up to 5 years ]
  • Growth data as measured by body weight [ Time Frame: Up to 5 years ]
  • Development as measured by Tanner Pubertal Stage Assessment [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures
 (submitted: July 27, 2015)
  • Growth data as measured by body height [ Time Frame: Up to 5 years ]
  • Growth data as measured by body weight [ Time Frame: Up to 5 years ]
  • Development as measured by Tanner Pubertal Stage Assessment [ Time Frame: Up to 5 years ]
  • Incidence of adverse events [ Time Frame: Up to 5 years ]
    The percentage of participants experiencing any adverse event will be summarized.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
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)
Condition Hepatitis C Virus Infection
Intervention
  • 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 6, 2022)		 461
Original Estimated Enrollment
 (submitted: July 27, 2015)		 500
Actual Study Completion Date January 6, 2023
Actual Primary Completion Date January 6, 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Belgium,   Germany,   Italy,   New Zealand,   Poland,   Russian Federation,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02510300
Other Study ID Numbers GS-US-334-1113
2014-004674-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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
Supporting Materials: 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/
Current Responsible Party Gilead Sciences
Original Responsible Party Same as current
Current Study Sponsor Gilead Sciences
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date January 2023