Envarsus Neurotoxicity Burden in Liver Transplant Patients
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|ClinicalTrials.gov Identifier: NCT03823768|
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : March 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neurotoxicity Liver Transplant; Complications||Drug: Envarsus Drug: Tacrolimus Immediate release||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Conversion to Once-Daily Envarsus® on the Neurologic Toxicity Burden in Liver Transplant Recipients|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Active Comparator: Arm 1: Control
Tacrolimus immediate release twice daily for 6 months
Drug: Tacrolimus Immediate release
Subjects in this group will take Tacrolimus immediate release for 6 months of treatment (goal 12 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.
Experimental: Arm 2: Intervention
Envarsus daily for 6 months.
Subjects in this group will take Envarsus daily for 6 months of treatment (goal 24 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.
- Change in neurotoxicity burden [ Time Frame: 6 months ]Estimate the change from baseline to six months in neurotoxicity burden measured by a composite Patient Global Impression of Improvement score
- Change in mean Fahn-Tolosa-Marin (FTM) score [ Time Frame: 6 months ]Estimate the change in the mean FTM score among patients with self-reported tremors from baseline to six months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823768
|Contact: Courtney Rowley, MSfirstname.lastname@example.org|
|Contact: Caitlin Schaffner, MPHemail@example.com|
|Principal Investigator:||Derek Dubay, MD||Medical University of South Carolina|