Status:
TERMINATED
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
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
3-17 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combinati...
Detailed Description
Participants will receive placebo to match SOF/VEL/VOX FDC to assess ability to swallow tablets at screening up to Day 1.
Eligibility Criteria
Inclusion
- Key
- Consent of parent or legal guardian required
- 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)
- Key
Exclusion
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- 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
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
January 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03820258
Start Date
January 28 2019
End Date
February 19 2020
Last Update
October 23 2020
Active Locations (10)
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1
SOS-intraSOC Epatologia
Florence, Italy, 50139
2
Servizio di Epatologia e Nutrizione Pediatrica
Milan, Italy, 20122
3
US Infettivologia Pediatrica-Polo Universitario
Milan, Italy, 20157
4
UOS Epatologia Pediatrica
Napoli, Italy, 80131