Status:
COMPLETED
Envarsus Neurotoxicity Burden in Liver Transplant Patients
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Neurotoxicity
Liver Transplant; Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will compare neurologic side effects associated with two immunosuppressant medications used in liver transplant patients. The standard therapy of twice daily immediate release Tacrolimus wi...
Eligibility Criteria
Inclusion
- Male or female adult (≥18 years old) with a history of liver or liver/kidney transplant within the first 6 months of transplant.
- Patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study.
Exclusion
- Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner
- HIV positive (HIV ab +)
- Unable to tolerate oral medications
- Use of another investigational product within thirty days prior to receiving study medication
- Moderate acute cellular rejection (RAI ≥ 5) within the past month
- A condition that is known to cause tremor such as essential tremor, Parkinson disease, or enhanced physiologic tremor.
- Patients taking medications known to induce tremors or dopamine blocking agents
- A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject
Key Trial Info
Start Date :
January 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03823768
Start Date
January 31 2020
End Date
January 30 2024
Last Update
March 30 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425