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A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant (NCT02781571)

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.
  • Drug: SOF/VEL
    400/100 mg tablet administered orally once daily
    • Epclusa®
    • GS-7977/GS-5816
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • History of chronic HCV prior to liver transplant with HCV reoccurrence post-transplant
  • HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
  • Individuals ≥ 3 months post-liver transplant with chronic HCV reoccurrence
  • Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis
  • Metavir stage 3 or 4 fibrosis/cirrhosis or corresponding fibrosis Key
Exclusion Criteria:
  • 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 or hepatitis B virus
  • Known hypersensitivity to study medication,
  • Use of any prohibited concomitant medications as within with window before the Day 1 visit. NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

15 locations

Status:
completed
Type:
Interventional
Phase:
Start:
26 July, 2016
Updated:
02 August, 2017
Participants:
79
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