Status:
COMPLETED
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic 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 the PK Lead-in Phase of the study is to evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) in...
Eligibility Criteria
Inclusion
- Key
- Consent of parent or legal guardian required
- Chronic HCV infection
- Screening laboratory values within defined thresholds
- Key
Exclusion
- History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol.
- Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
- Clinical hepatic decompensation (i.e., ascites, encephalopathy 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 :
November 5 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2018
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT02249182
Start Date
November 5 2014
End Date
August 24 2018
Last Update
March 2 2020
Active Locations (31)
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1
Birmingham, Alabama, United States
2
Los Angeles, California, United States
3
San Francisco, California, United States
4
Aurora, Colorado, United States