Clinical Trial

Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

Active, Not Recruiting Phase 2/3
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Record status
This record was last updated January 8, 2021 (before its estimated December 31, 2021 completion). Its status may not reflect the trial's current state.
Summary
This study will evaluate the medication adherence, clinical efficacy, and safety of EnvarsusXR in stable post liver transplant patient using a Phase III randomized controlled study. The primary outcome is change in medication adherence from baseline to the end of the study, assessed using a validated instrument (BAASIS- Basel Assessment of Adherence with Immunosuppressive medication Scales) and standard deviation of Tacrolimus levels.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2017-12-28; most recent amendment 2024-08-06.
Status change: Active, Not Recruiting → Completed 2022-10-26
Status change: Recruiting → Active, Not Recruiting 2021-01-07
Trial Details
NCT Number NCT03386305
Lead Sponsor Albert Einstein Healthcare Network
Collaborators: Veloxis Pharmaceuticals
Conditions Post Liver Transplant
Enrollment 35 participants
Start Date 2017-12-13
Primary Completion 2021-12-31 (estimated)
Study Completion 2021-12-31 (estimated)
Updated on ClinicalTrials.gov 2021-01-08