Hepatitis C
Conditions
Interventions
Sponsors
Afdeling Apotheek
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.Patients with sofosbuvir/velpatasvir treatment for the treatment of chronic hepatitis C 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.
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 except for conditions related to HCV. 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 |
|---|---|
| The primary aim of this study is to assess the bioequivalence of SOF/VEL administered as a crushed (test) tablet compared to a whole (reference) tablet in patients treated with SOF/VEL. Geometric Mean Ratios and the 90% CI interval of the pharmacokinetic parameters (AUC0-tau, Cmax,ss and Ctrough) and median of t* 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Germany, Netherlands
Outcome results
None listed