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ACTIVE NOT RECRUITING
NCT03386305
PHASE2/PHASE3

Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

Sponsor: Albert Einstein Healthcare Network

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Trial to Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2017-12-13

Completion Date

2021-12-31

Last Updated

2021-01-08

Healthy Volunteers

No

Interventions

DRUG

EnvarsusXR

Patients randomized to study drug will be converted to EnvarsusXR once daily.

DRUG

Tacrolimus

Patients continue to take Tacrolimus BID, as a part of routine care.

Locations (1)

Einstein Medical Center

Philadelphia, Pennsylvania, United States