Status:
WITHDRAWN
Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet
Lead Sponsor:
Radboud University Medical Center
Conditions:
HCV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and...
Eligibility Criteria
Inclusion
- Patients with SOF/VEL treatment for the treatment of chronic HCV genotype 1 through 6.
- Patient is at least 18 at the day of screening.
- Patient is able and willing to sign the Informed Consent Form.
- Patient is able and willing to follow protocol requirements.
Exclusion
- Pregnant female (as confirmed by an hCG urine test performed at screening) or breast-feeding female.
- Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- Inability to understand the nature and extent of the study and the procedures required.
- Clinically relevant low hemoglobin concentration at screening judged by the patient's own hepatologist.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03389061
Start Date
April 1 2018
End Date
March 22 2019
Last Update
December 7 2020
Active Locations (3)
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1
University of Bonn, Germany
Bonn, Germany
2
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
3
Radboud university medical center Department of GI tract
Nijmegen, Netherlands