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) |
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.
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
111 Michigan Ave NW
Washington, District of Columbia
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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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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1800 Orleans Street
Baltimore, Maryland 21287
Baltimore, Maryland 21287
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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700 Children's Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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