Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

Description

This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase. The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection. The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.

Study Start Date

January, 26 2017

Estimated Completion Date

January 2020

Interventions

  • Drug: SOF/VEL

Study ID

Gilead Sciences -- GS-US-342-1143

Status

Recruiting

Trial ID

NCT03022981

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

200

Sponsor

Gilead Sciences

Key

Inclusion Criteria

  • Chronic HCV-infected, treatment-naive and treatment-experienced adolescent and pediatric individuals aged 3 to < 18 as determined at Day 1. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Gender

All

Ages

3 Years to 17 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (58)

Study Location Distance Name Phone Email
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Mount Sinai Medical Center - New York, New York 183.2 miles None None None
The Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles None None None
The Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles None None None
The Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles None None None
The Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles None None None
The Childrens Hospital of Philadelphia - Philadelphia, Pennsylvania 270.8 miles None None None
Johns Hopkins University JHU The Johns Hopkins Hospital JHH - Baltimore, Maryland 356.0 miles None None None
Johns Hopkins University JHU The Johns Hopkins Hospital JHH - Baltimore, Maryland 356.0 miles None None None
Johns Hopkins University JHU The Johns Hopkins Hospital JHH - Baltimore, Maryland 356.0 miles None None None
Johns Hopkins University JHU The Johns Hopkins Hospital JHH - Baltimore, Maryland 356.0 miles None None None
Johns Hopkins University JHU The Johns Hopkins Hospital JHH - Baltimore, Maryland 356.0 miles None None None
Childrens National Medical Center - Washington, District of Columbia 391.7 miles None None None
Childrens National Medical Center - Washington, District of Columbia 391.7 miles None None None
Childrens National Medical Center - Washington, District of Columbia 391.7 miles None None None
Childrens National Medical Center - Washington, District of Columbia 391.7 miles None None None
Childrens National Medical Center - Washington, District of Columbia 391.7 miles None None None
Nationwide Childrens Hospital The Ohio State University OSU - Columbus, Ohio 640.0 miles None None None
Nationwide Childrens Hospital The Ohio State University OSU - Columbus, Ohio 640.0 miles None None None
Nationwide Childrens Hospital The Ohio State University OSU - Columbus, Ohio 640.0 miles None None None
Nationwide Childrens Hospital The Ohio State University OSU - Columbus, Ohio 640.0 miles None None None
Nationwide Childrens Hospital The Ohio State University OSU - Columbus, Ohio 640.0 miles None None None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles None None None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles None None None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles None None None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles None None None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles None None None
Emory Childrens Center - Atlanta, Georgia 932.0 miles None None None
Emory Childrens Center - Atlanta, Georgia 932.0 miles None None None
Emory Childrens Center - Atlanta, Georgia 932.0 miles None None None
Emory Childrens Center - Atlanta, Georgia 932.0 miles None None None
Emory Childrens Center - Atlanta, Georgia 932.0 miles None None None
University of Florida Shands Medical - Gainesville, Florida 1,081.3 miles None None None
Baylor College of Medicine - Houston, Texas 1,609.9 miles None None None
Childrens Hospital of Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Hospital of Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Hospital of Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Hospital of Colorado - Aurora, Colorado 1,759.8 miles None None None
Childrens Hospital of Colorado - Aurora, Colorado 1,759.8 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles None None None
Seattle Childrens Hospital - Seattle, Washington 2,487.2 miles None None None
Childrens Hospital Los Angeles - Los Angeles, California 2,595.3 miles None None None
Childrens Hospital Los Angeles - Los Angeles, California 2,595.3 miles None None None
Childrens Hospital Los Angeles - Los Angeles, California 2,595.3 miles None None None
Childrens Hospital Los Angeles - Los Angeles, California 2,595.3 miles None None None
Childrens Hospital Los Angeles - Los Angeles, California 2,595.3 miles None None None
University of California San Francisco - San Francisco, California 2,696.4 miles None None None
University of California San Francisco - San Francisco, California 2,696.4 miles None None None
University of California San Francisco - San Francisco, California 2,696.4 miles None None None
University of California San Francisco - San Francisco, California 2,696.4 miles None None None
University of California San Francisco - San Francisco, California 2,696.4 miles None None None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.