Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03386305 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Enrollment target: 60 to 35
    • Primary and study completion dates: Dec 31, 2020 to Dec 31, 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  2. Enrollment target: 120 to 60
    • Primary and study completion dates: Dec 13, 2019 to Dec 31, 2020
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03386305
Lead Sponsor Albert Einstein Healthcare Network
Collaborators: Veloxis Pharmaceuticals
Conditions
(from sponsor)		 Post Liver Transplant
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov