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NCT03386305 · ClinicalTrials.gov registry record · Phase 2
Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant
A Phase 2 study of Post Liver Transplant, sponsored by Albert Einstein Healthcare Network.
- Active
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT03386305: Active Phase 2 study of Post Liver Transplant, sponsored by Albert Einstein Healthcare Network.
NCT03386305 is a Phase 2 study of Post Liver Transplant that is active but no longer recruiting, run by Albert Einstein Healthcare Network. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03386305, a Phase 2 study of Post Liver Transplant, is active but no longer recruiting, sponsored by Albert Einstein Healthcare Network.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Self reported using BAASIS instrument. BAASIS measures taking, skipping and dose reduction of drugs, with a recall period of 4 weeks. It consists of 4 questions with a 6 point response scale (ranging from never to every day). An additional overall adherence is ranked on a scale of 0 to 100 using a visual analog scale.
Conditions Studied
Interventions
- DRUG Tacrolimus
- DRUG EnvarsusXR
Study Locations (1)
Pennsylvania
- Einstein Medical Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-12-13 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03386305 still lists
NCT03386305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Post Liver Transplant appearing as the primary indexed condition, and to 2 interventions - of which Tacrolimus is the first listed.
NCT03386305 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03386305 about?
NCT03386305 is a clinical study titled "Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant". 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 validate...
What is the current status of trial NCT03386305?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2017-12-13. Estimated completion is 2021-12-31.
What conditions does trial NCT03386305 study?
This clinical trial studies the following conditions: Post Liver Transplant.
What interventions are being tested in trial NCT03386305?
The interventions under investigation include: Tacrolimus (DRUG), EnvarsusXR (DRUG).
Who is sponsoring clinical trial NCT03386305?
This trial is sponsored by Albert Einstein Healthcare Network, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03386305 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post Liver Transplant
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03386305's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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