hepatitis C virus MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Epclusa
Pharmaceutical Form: Tablet
INN or Proposed INN: VELPATASVIR
CAS Number: 1377049-84-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN o
Sponsors
Radboud University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with SOF/VEL treatment for the treatment of chronic HCV genotype 1 through 6. 2. Patient is at least 18 at the day of screening. 3. Patient is able and willing to sign the Informed Consent Form. 4. Patient is able and willing to follow protocol requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Pregnant female (as confirmed by an hCG test performed 4 weeks before Day 84) or breast-feeding female. 2. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. 3. Inability to understand the nature and extent of the study and the procedures required. 4. Clinically relevant low hemoglobin concentration at screening judged by the patient’s own physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the bioequivalence of SOF/VEL as a crushed (test) tablet compared to a whole (reference) tablet in patients treated with SOF/VEL.;Secondary Objective: To evaluate the safety and tolerability of crushed Epclusa tablets in patients. ;Primary end point(s): Geometric Mean Ratios and the 90% CI interval of the pharmacokinetic parameters (AUC0-tau, Cmax,ss and Ctrough) and median of t½ and tmax,ss of sofosbuvir, GS-331007 and velpatasvir of a crushed tablet (intervention) compared to a whole tablet (reference). AUC0-24 and Cmax,ss GMR with a 90% CI falling entirely within the range of 0.8 to 1.25 are considered bioequivalent. ;Timepoint(s) of evaluation of this end point: Pharmacokinetic (PK) curves will be recorded for sofosbuvir and velpatasvir. The curve will be recorded after administration of a whole tablet and a crushed tablet. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the safety and tolerability of crushed SOF/VEL tablets in patients. Adverse events after administration of (crushed) SOF/VEL will be described and compared (including clinically relevant laboratory abnormalities). ;Timepoint(s) of evaluation of this end point: Safety assessment on every study visit. Evaluation at the end of the trial. | — |
Countries
Netherlands
Contacts
Public ContactDavid Burger
Radboud University Medical Center
Outcome results
None listed