Minocycline Administration During Human Liver Transplantation

NCT02712775 | Withdrawn Phase 4

• 1 other identifier: MCL-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Liver transplantation is the sole therapy for end-stage liver diseases and acute liver failure in children and adults. However, use of this life-saving technique is limited due to a severe shortage of donor livers. The number of transplants currently performed is approximately one-third of the number needed to accommodate the more than 16,000 patients awaiting an organ in the US. Over 20% of patients on the liver transplant waiting list die prior to transplantation due to organ shortages. The median waiting time in 2011 was over 300 days. Poor immediate graft function and primary non function (PNF) are clinically significant events, especially in recipients of marginal livers (elderly donors, extended cold storage time, or steatosis). PNF has dramatic effects on patient morbidity and mortality, necessitating prolonged and expensive stays in intensive care units, and re-transplantation is the only life-saving therapy in patients with failing liver grafts due to PNF. This further exerts greater burden on the already scarce donor organ pool. Furthermore, biliary strictures and ischemic cholangiopathy, as a result of severe ischemia reperfusion injury, cause prolonged hospital stay, long-term complications, and increased costs. Targeted treatments, such as the one proposed in this application, will reduce the need for re-transplantation, reduce biliary injury, and potentially increase the number of donor organs available.

Conditions

Liver Disease

Outcome Measures

Primary Outcomes (1)

• AST

  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.

  6 month

Study Arms (2)

Minocycline

EXPERIMENTAL

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)

Saline

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Minocycline (yes/no) DRUG

Minocycline

Placebo DRUG

Saline

Saline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult primary transplant recipients of solitary orthotopic liver transplants are considered for this study

You may not qualify if:

• Pediatric patients, fulminant hepatic failures, split livers, living donor liver transplants, multiple organs, known tetracycline hypersensitivity, and re-transplant patients are excluded.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Kenneth Chavin, MD, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 18, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 18, 2018

Record last verified: 2016-03

Locations

US (1)