Minocycline Administration During Human Liver Transplantation
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|ClinicalTrials.gov Identifier: NCT02712775|
Recruitment Status : Withdrawn (Study logistics)
First Posted : March 18, 2016
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Liver Disease||Drug: Minocycline (yes/no) Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Minocycline Administration During Human Liver Transplantation|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental group will receive an infusion of minocycline, the investigational drug, through a needle in a vein in the arm at the dose of 200 mg at 1 h prior to transplantation and 100 mg 12 h and 24 h after transplantation. In addition, the donated liver will be flushed with 200 mg minocycline 1 h prior to transplantation.
Drug: Minocycline (yes/no)
Placebo Comparator: Saline
Placebo group will receive an infusion of saline, a placebo, through a needle in a vein in the arm according to the same schedule. In addition, the donated liver will be flushed with saline 1 h prior to transplantation.
- AST [ Time Frame: 6 month ]AST is the primary endpoint our study is powered to detect. Peak AST >1500 IU/L is associated with clinical sequel of IRI such as severe graft dysfunction and complications.
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): NCT02712775
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29401|
|Principal Investigator:||Kenneth Chavin, MD, PhD||Medical University of South Carolina|