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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 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. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03386305
The ClinicalTrials.gov registry entry for NCT03386305 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein Healthcare Network, which has 48 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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