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 type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Not applicable
• If ‘Not applicable’, further details on the study type:
  Interventional Registry study

Population studied

• Short description of the study population:
  The study focused on adolescent and pediatric subjects who received at least one Gilead hepatitis C virus direct acting antiviral (DAA) identified from the Gilead-sponsored chronic hepatitis C study.; Inclusion Criteria:;  Have previously participated in a Gilead-sponsored chronic hepatitis C study as an adolescent or pediatric subject and received at least one Gilead HCV direct acting antiviral (DAA);;  Parent or legal guardian able to provide written informed consent OR subject able to provide written informed consent and willing to comply with study requirements, as determined by IRB/IEC/local requirements and Investigator’s discretion.;  Subject 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; ; Exclusion Criteria:;  Subject 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.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To determine the long-term safety of anti-HCV regimens in the pediatric population as determined by assessments of growth and development.
• Outcomes:
  Growth data by visit grouped by age and gender and development by Tanner Pubertal Stage Assessment. The proportion of subjects maintaining SVR.
• Data analysis plan:
  Data from this Registry study was summarized descriptively. Statistical hypothesis testing was not conducted. All continuous variables were summarized using an 8-number descriptive summary (n, mean, standard deviation, and median, Q1, Q3, minimum, maximum) by visit. All categorical variables were summarized by number and percentage of subjects in each categorical definition.

Documents

Study results

GS-US-334-1113-CSR-synopsis_f-redact