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NCT02249182 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
A Phase 2 study of Hepatitis C Virus Infection, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 226
- Enrollment target
- 20
- Study locations
NCT02249182: Completed Phase 2 study of Hepatitis C Virus Infection, sponsored by Gilead Sciences.
NCT02249182 is a Phase 2 study of Hepatitis C Virus Infection that has completed, run by Gilead Sciences. The registered enrollment target is 226 participants, above the 157-participant average among 5 other Hepatitis C Virus Infection trials with a reported enrollment target (44% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02249182, a Phase 2 study of Hepatitis C Virus Infection, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 226 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in HCV-infected pediatric participants. The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The primary objective of the Treatment Phase is to evaluate the antiviral efficacy, safety, and tolerability of LDV/SOF FDC +/- ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV. During screening, participants will receive placebo to match LDV/SOF FDC to assess ability to swallow tablets.
Primary Outcome
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Conditions Studied
Interventions
- DRUG RBV
- DRUG LDV/SOF
Study Locations (20)
California
- - Los Angeles
- - San Francisco
Ohio
- - Cincinnati
- - Columbus
Texas
- - Dallas
- - Fort Worth
Alabama
- - Birmingham
Colorado
- - Aurora
District of Columbia
- - Washington D.C.
Georgia
- - Atlanta
Indiana
- - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2014-11-05 |
| Est. Completion | 2018-08-24 |
| Phase | Phase 2 |
What the finished NCT02249182 record still lists
NCT02249182 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, above the 157-participant average among 5 other Hepatitis C Virus Infection trials with a reported enrollment target (44% higher).
The record links to 1 condition, with Hepatitis C Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which RBV is the first listed.
NCT02249182 names 20 study sites across 17 states, led by California, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT02249182 about?
NCT02249182 is a clinical study titled "Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection". The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate th...
What is the current status of trial NCT02249182?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 226 participants. The study started on 2014-11-05. Estimated completion is 2018-08-24.
What conditions does trial NCT02249182 study?
This clinical trial studies the following conditions: Hepatitis C Virus Infection.
What interventions are being tested in trial NCT02249182?
The interventions under investigation include: RBV (DRUG), LDV/SOF (DRUG).
Who is sponsoring clinical trial NCT02249182?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02249182 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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