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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 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.

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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.

Conditions Studied

Hepatitis C Virus Infection

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

FieldValue
Enrollment Target 226 participants
Start Date 2014-11-05
Est. Completion 2018-08-24
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02249182

The ClinicalTrials.gov registry entry for NCT02249182 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 157-participant average among 5 other Hepatitis C Virus Infection trials with a reported enrollment target (44% higher). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 17 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.