drugset / Trial / NCT03386305
Evaluate the Clinical Benefits of EnvarsusXR in Post Liver Transplant
Phase 2/3
Active not recruiting
35 enrolled
Albert Einstein Healthcare Network
Veloxis Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2017-12-13
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tacrolimus | Small molecule | — | — |
| Comparator | Tacrolimus | Small molecule | — | — |
Indications
No indication recorded.