Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet (CRUSADE-1)
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|ClinicalTrials.gov Identifier: NCT03389061|
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : April 12, 2018
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 the NS5A inhibitor velpatasvir (VEL) 100 mg.
For patients with swallowing difficulties, administration of whole tablets can be problematic. In addition, HCV patients that are hospitalized (at intensive care units) due to severe illness (co-infections/ liver failure) might not be able to swallow medication. Therefore it is useful to know whether it is possible to administer SOF/VEL through a different route, like a feeding tube.
In daily practice, information about the safety and efficacy of crushed tablets is lacking which might result in interruption or discontinuation of expensive HCV therapy. However, it is not recommended to interrupt treatment because there is no evidence about the efficacy of the therapy after discontinuation (and restart).
Currently, patients and healthcare professionals are crushing SOF/VEL tablets without information about efficacy and safety. Depending on the biopharmaceutical characteristics of a drug formulation, crushing tablets can lead to altered pharmacokinetics of drugs.
It is important to know whether pharmacokinetic parameters are influenced by crushing of tablets; both a decrease and an increase in exposure may occur. A decrease of the plasma concentrations of SOF and/or VEL potentially reduces the therapeutic effect of the drugs. Higher doses or switching to other HCV-drugs might be needed. In contrast, in case a higher Cmax,ss and/or exposure occurs there might be an increased risk of toxicity.
As a result, crushing the drug is a contra-indication based on the available data.
Therefore this study will be conducted to investigate whether a crushed SOF/VEL tablet is bioequivalent to SOF/VEL as a whole tablet.
|Condition or disease||Intervention/treatment||Phase|
|HCV||Drug: sofosbuvir/velpatasvir tablet Drug: sofosbuvir/velpatasvir crushed||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Bio-equivalence Study|
|Masking:||None (Open Label)|
|Official Title:||Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||December 1, 2018|
Active Comparator: sofosbuvir/velpatasvir tablet
Single-dose sofosbuvir/velpatasvir as a whole tablet in a fasted state.
Drug: sofosbuvir/velpatasvir tablet
Single-dose SOF/VEL as a whole tablet in a fasted state.
Experimental: sofosbuvir/velpatasvir crushed
Single-dose crushed sofosbuvir/velpatasvir in a fasted state.
Drug: sofosbuvir/velpatasvir crushed
Single-dose crushed SOF/VEL in a fasted state.
- AUC [ Time Frame: Up to 24 hours after administration ]
- Cmax [ Time Frame: one dosing interval after administration of SOF/VEL (up to 24 hours) ]
- Adverse events [ Time Frame: During the entire conduct of the study, maximum of two weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389061
|Contact: Minou van Seyen, MSc||+31 24 361 64 email@example.com|
|Contact: David M Burger, Prof.||+31 24 361 64 05||David.Burger@radboudumc.nl|
|University of Bonn, Germany||Not yet recruiting|
|Contact: Juergen Rockstroh|
|Jeroen Bosch Hospital||Not yet recruiting|
|Contact: Bram Schaap|
|Sub-Investigator: Jeroen Derijks|
|Radboud university medical center Department of GI tract||Recruiting|
|Contact: Joost Drenth|