Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet
NCT ID: NCT03389061
Last Updated: 2020-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2018-04-01
2019-03-22
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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sofosbuvir/velpatasvir tablet
Single-dose sofosbuvir/velpatasvir as a whole tablet in a fasted state.
sofosbuvir/velpatasvir tablet
Single-dose SOF/VEL as a whole tablet in a fasted state.
sofosbuvir/velpatasvir crushed
Single-dose crushed sofosbuvir/velpatasvir in a fasted state.
sofosbuvir/velpatasvir crushed
Single-dose crushed SOF/VEL in a fasted state.
Interventions
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sofosbuvir/velpatasvir tablet
Single-dose SOF/VEL as a whole tablet in a fasted state.
sofosbuvir/velpatasvir crushed
Single-dose crushed SOF/VEL in a fasted state.
Eligibility Criteria
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Inclusion Criteria
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
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 hepatologist.
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Locations
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University of Bonn, Germany
Bonn, , Germany
Jeroen Bosch Hospital
's-Hertogenbosch, , Netherlands
Radboud university medical center Department of GI tract
Nijmegen, , Netherlands
Countries
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References
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van Seyen M, Samson AD, Cullen L, Eastick K, Knol H, Colbers A, Burger DM. Crushed application of sofosbuvir and velpatasvir in a patient with swallowing disorder. Int J Antimicrob Agents. 2020 Jun;55(6):105934. doi: 10.1016/j.ijantimicag.2020.105934. Epub 2020 Mar 7. No abstract available.
Other Identifiers
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UMCN-AKF 16.06
Identifier Type: -
Identifier Source: org_study_id