Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection
NCT ID: NCT03820258
Last Updated: 2020-10-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
21 participants
INTERVENTIONAL
2019-01-28
2020-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Experimental: Cohort 1 (12 to < 18 years old), 8 Weeks
Direct-acting antiviral (DAA)-naive participants without cirrhosis in Cohort 1 (12 to \< 18 years old) will receive SOF/VEL/VOX FDC 400/100/100 mg for 8 weeks.
SOF/VEL/VOX
Administered once daily with food.
Experimental: Cohort 1 (12 to < 18 years old), 12 Weeks
DAA-naive participants with cirrhosis or DAA-experienced participants with or without cirrhosis in Cohort 1 (12 to \< 18 years old) will receive SOF/VEL/VOX FDC 400/100/100 mg for 12 weeks.
SOF/VEL/VOX
Administered once daily with food.
Experimental: Cohort 2 (6 to < 12 years old), 8 Weeks
DAA-naive participants without cirrhosis in Cohort 2 (6 to \< 12 years old) will receive SOF/VEL/VOX FDC for 8 weeks.
SOF/VEL/VOX
Administered once daily with food.
Experimental: Cohort 2 (6 to < 12 years old), 12 Weeks
DAA-naive participants with cirrhosis or DAA-experienced participants with or without cirrhosis in Cohort 2 (6 to \< 12 years old) will receive SOF/VEL/VOX FDC for 12 weeks.
SOF/VEL/VOX
Administered once daily with food.
Experimental: Cohort 3 (3 to < 6 years old), 8 Weeks
DAA-naive participants without cirrhosis in Cohort 3 (6 to \< 12 years old) will receive SOF/VEL/VOX FDC for 8 weeks.
SOF/VEL/VOX
Administered once daily with food.
Experimental: Cohort 3 (3 to < 6 years old), 12 Weeks
DAA-naive participants with cirrhosis or DAA-experienced participants with or without cirrhosis in Cohort 3 (3 to \< 6 years old) will receive SOF/VEL/VOX FDC for 12 weeks.
SOF/VEL/VOX
Administered once daily with food.
Interventions
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SOF/VEL/VOX
Administered once daily with food.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic HCV infection
* Screening laboratory values within defined thresholds
* Individuals must have a determination of prior treatment status:
* DAA-naive is defined as either:
* Treatment naive with no prior exposure to any interferon (IFN), ribavirin (RBV), or approved or experimental HCV-specific DAA
* Treatment experienced with an IFN-based regimen and no prior exposure to an approved or experimental HCV-specific DAA
* DAA-experienced is defined as prior exposure to a regimen including any DAA (eg, non-structural protein (NS)3/4A protease inhibitor, NS5A inhibitor, or NS5B nucleotide/nucleoside inhibitor)
Exclusion Criteria
* Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV) or hepatitis B virus (HBV)
* Clinical hepatic decompensation (eg, clinical ascites, encephalopathy, and/or variceal hemorrhage)
* Pregnant or nursing females
* Known hypersensitivity to study medication
* Use of any prohibited concomitant medications as within 28 days of the Day 1 visit
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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SOS-intraSOC Epatologia
Florence, , Italy
Servizio di Epatologia e Nutrizione Pediatrica
Milan, , Italy
US Infettivologia Pediatrica-Polo Universitario
Milan, , Italy
UOS Epatologia Pediatrica
Napoli, , Italy
UOSD Epatologia
San Giovanni Rotondo, , Italy
Wojewodzki Szpital
Bydgoszcz, , Poland
Med Polonia
Poznan, , Poland
Uniwersytecki Szpital Kliniczny im.
Wroclaw, , Poland
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, , United Kingdom
Kings Healthcare NHS Trust Hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2018-000480-87
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-367-1175
Identifier Type: -
Identifier Source: org_study_id
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