Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - 17
Updated:3/28/2019
Start Date:January 26, 2017
End Date:January 2020
Contact:Gilead Clinical Study Information Center
Email:GileadClinicalTrials@gilead.com
Phone:1-833-445-3230 (GILEAD-0)

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

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.


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.
We found this trial at
22
sites
University of Florida Shands Medical
1600 Southwest Archer Road
Gainesville, Florida 32610
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Cincinnati Children's Hospital Medical Center
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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Baylor College of Medicine
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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Children's Mercy Hospital
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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Childrens Hospital Los Angeles
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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Mount Sinai Hospital
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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Emory Children's Center
Atlanta, Georgia 30322
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Atlanta, GA
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Children's Hospital Colorado
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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Johns Hopkins University (JHU) - The Johns Hopkins Hospital (JHH)
1800 Orleans Street
Baltimore, Maryland 21287
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Baltimore, MD
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Boston Children's Hospital
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Cliniques Universitaires Saint-Luc
Brussels,
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Brussels,
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Nationwide Children's Hospital- The Ohio State University (OSU)
700 Children's Drive
Columbus, Ohio 43205
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Columbus, OH
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Cook Children's Medical Center
801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Fort Worth, TX
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Riley Hospital for Children
705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky 40202
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Louisville, KY
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Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
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Nashville, TN
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Childrens Hospital & Medical Center
Omaha, Nebraska 68114
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Omaha, NE
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Florida Gastroenterology Care for Children
Orlando, Florida 32803
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Orlando, FL
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University of California at San Francisco
San Francisco, California 94143
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San Francisco, CA
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Seattle Children's Hospital
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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Childrens National Medical Center
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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