MedTrace Logo

Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

NCT03386305 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-01-08

No results posted yet for this study

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.

Conditions

  • Post Liver Transplant

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.

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    collaborator INDUSTRY

  • Albert Einstein Healthcare Network

    lead OTHER

Principal Investigators

  • Manisha Verma, MBBS, MPH · Einstein Healthcare Network

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-13
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386305 on ClinicalTrials.gov