Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02544113 · ClinicalTrials.gov registry record · Phase 2

A Randomized Controlled Clinical Trial of Thymoglobulin® After Liver Transplantation

A Phase 2 study of Liver Failure, sponsored by The Cleveland Clinic.

Completed
Registry status
Phase 2
Development phase
110
Enrollment target
4
Study locations

NCT02544113 is a Phase 2 study of Liver Failure that has completed, run by The Cleveland Clinic. The registered enrollment target is 110 participants, below the 153-participant average among 7 other Liver Failure trials with a reported enrollment target (28% lower). The trial reports 4 study locations across 3 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02544113, a Phase 2 study of Liver Failure, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
Phase 2
Development phase
110 participants
Enrollment target
4
Study locations

Study Summary

This is a 24-month, Phase II, multi-center, two-arm, randomized controlled study of adult patients receiving a single organ liver transplant from a deceased donor; the purpose being to determine the efficacy of Thymoglobulin® induction and delayed initiation of CNI in the long-term preservation of renal function after liver transplantation. This study is based on the outcomes of an earlier phase 1 pilot study which was performed at the Cleveland Clinic. This study will be conducted at 3 centers, with 110 subjects randomized 1:1 into two groups: Group 1 will receive Thymoglobulin® induction, (4.5 mg/Kg, in 3 doses of 1.5 mg/Kg/dose) with delayed initiation of CNI to begin on Day 10 post LT. Group 2 will receive early CNI initiation (to be started no later than Day 2 post LT), and no Thymoglobulin® induction (or any other antibody). All subjects will also receive a maintenance immunosuppressive regimen consisting of corticosteroids and mycophenolate mofetil (MMF) according to standard of practice in orthotopic liver transplantation (OLT). Subjects will be consented pre-transplant. Participation may last up to 12 months post OLT. There are 15 study-related visits which will be completed during standard of care (SOC) visits.

Conditions Studied

Liver Failure

Interventions

  • DRUG Placebo
  • DRUG Thymoglobulin

Study Locations (4)

Ohio

  • University of Cincinnati College of Medicine - Cincinnati
  • Cleveland Clinic (Main Campus) - Cleveland

Florida

  • Cleveland Clinic Florida - Weston

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2015-12
Est. Completion 2020-01-03
Phase Phase 2

Sponsor

The Cleveland Clinic

688 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02544113

The ClinicalTrials.gov registry entry for NCT02544113 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 153-participant average among 7 other Liver Failure trials with a reported enrollment target (28% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Liver Failure appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02544113 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Ohio, Florida, Wisconsin.

Frequently Asked Questions

What is clinical trial NCT02544113 about?

NCT02544113 is a clinical study titled "A Randomized Controlled Clinical Trial of Thymoglobulin® After Liver Transplantation". This is a 24-month, Phase II, multi-center, two-arm, randomized controlled study of adult patients receiving a single organ liver transplant from a deceased donor; the purpose being to determine the efficacy of Thymoglobulin® induction and delayed initiation of CNI in the long-term preservation of r...

What is the current status of trial NCT02544113?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2015-12. Estimated completion is 2020-01-03.

What conditions does trial NCT02544113 study?

This clinical trial studies the following conditions: Liver Failure.

What interventions are being tested in trial NCT02544113?

The interventions under investigation include: Placebo (DRUG), Thymoglobulin (DRUG).

Who is sponsoring clinical trial NCT02544113?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02544113 being conducted?

This trial has 4 study locations across Florida, Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Liver Failure

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Liver Failure

All registered trials for this condition

Florida

All trials with a study site in Florida

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.