Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
NCT ID: NCT03022981
Last Updated: 2020-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
216 participants
INTERVENTIONAL
2017-01-26
2020-02-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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12 to < 18 Years Old
PK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) 400/100 mg once daily for 7 days. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase.
Treatment Phase: SOF/VEL 400/100 mg once daily for 12 weeks.
SOF/VEL
SOF/VEL fixed-dose combination (FDC) 400/100 mg tablets or SOF/VEL FDC 200/50 mg tablets (based on swallowability assessment)
6 to < 12 Years Old
PK Lead-in Phase: SOF/VEL 200/50 mg once daily for 7 days. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase.
Treatment Phase: SOF/VEL 200/50 mg once daily for 12 weeks.
SOF/VEL
SOF/VEL fixed-dose combination (FDC) 400/100 mg tablets or SOF/VEL FDC 200/50 mg tablets (based on swallowability assessment)
3 to < 6 Years Old
PK Lead-in Phase: SOF/VEL 200/50 mg once daily for 7 days for participants who weigh ≥ 17 kg. SOF/VEL 150/37.5 mg once daily for 7 days for participants who weigh \< 17 kg. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase.
Treatment Phase: SOF/VEL 200/50 mg once daily for 12 weeks for participants who weigh ≥ 17 kg. SOF/VEL 150/37.5 mg once daily for 12 weeks for participants who weigh \< 17 kg.
SOF/VEL
SOF/VEL FDC 200/50 mg oral granules
Interventions
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SOF/VEL
SOF/VEL fixed-dose combination (FDC) 400/100 mg tablets or SOF/VEL FDC 200/50 mg tablets (based on swallowability assessment)
SOF/VEL
SOF/VEL FDC 200/50 mg oral granules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
3 Years
17 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida Shands Medical
Gainesville, Florida, United States
Florida Gastroenterology Care for Children
Orlando, Florida, United States
Emory Children's Center
Atlanta, Georgia, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
Johns Hopkins University (JHU) - The Johns Hopkins Hospital (JHH)
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Children's Hospital & Medical Center
Omaha, Nebraska, United States
Mount Sinai Medical Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital- The Ohio State University (OSU)
Columbus, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Cliniques Universitaires Saint Luc
Brussels, , Belgium
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S. Orsola - Malpighi
Bologna, , Italy
Azienda Ospedaliera Universitaria Meyer
Florence, , Italy
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
The Leeds Teaching Hospitals NHS Trust
Leeds, England, United Kingdom
King's College Hospital NHS Trust
London, England, United Kingdom
Countries
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References
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Jonas MM, Romero R, Sokal EM, Rosenthal P, Verucchi G, Lin CH, et al. The Safety and Efficacy of Sofosbuvir/Velpatasvir in Pediatric Patients 6 to < 18 years old with Chronic Hepatitis C Infection [Abstract]. AASLD; 2019 08-12 November; Boston, Massachusetts.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002446-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-342-1143
Identifier Type: -
Identifier Source: org_study_id
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