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NCT00117689 · ClinicalTrials.gov registry record · Phase 2

Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection

A Phase 2 study of Liver Dysfunction and Transplantation, Liver, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
75
Enrollment target
16
Study locations

NCT00117689: Completed Phase 2 study of Liver Dysfunction and Transplantation, Liver, sponsored by Genzyme, a Sanofi Company.

NCT00117689 is a Phase 2 study of Liver Dysfunction and Transplantation, Liver that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). The trial reports 16 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00117689, a Phase 2 study of Liver Dysfunction and Transplantation, Liver, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
75 participants
Enrollment target
16
Study locations

Study Summary

This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection. This study will evaluate the effect of Thymoglobulin induction therapy and reduced doses of calcineurin inhibitors on the incidence of liver rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help decrease the incidence of liver transplant rejection. Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. Approximately 75 study subjects from up to 18 transplant centers in the United States and Canada will be enrolled in this 12-month study.

Interventions

  • DRUG Corticosteroid
  • DRUG Mycophenolate Mofetil
  • DRUG Tacrolimus
  • BIOLOGICAL Thymoglobulin

Study Locations (16)

California

  • USC University Hospital - Los Angeles
  • University of California, San Fransisco Hospital - San Francisco

Florida

  • Mayo Clinic Jacksonville - Jacksonville
  • University of Miami - Miami

Texas

  • Baylor University Medical Center - Dallas
  • University of Texas Health Science Center at San Antonio, University Hospital - San Antonio

Alabama

  • University of Alabama, Birmingham - Birmingham

Colorado

  • University of Colorado Hospital and Health Sciences Center - Denver

Minnesota

  • Fairview University Medical Center - Minneapolis

Missouri

  • Washington University Medical Center - St Louis

Nebraska

  • University of Nebraska - Omaha

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2005-04
Est. Completion 2007-12
Phase Phase 2
Genzyme, a Sanofi Company

196 total trials

What the finished NCT00117689 record still lists

NCT00117689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).

The record links to 3 conditions, with Liver Dysfunction appearing as the primary indexed condition, and to 4 interventions - of which Corticosteroid is the first listed.

NCT00117689 lists 16 locations in 13 states (California, Florida, Texas).

Frequently Asked Questions

What is clinical trial NCT00117689 about?

NCT00117689 is a clinical study titled "Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection". This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection. This study will evaluate the effect of Thymoglobulin induction therapy and reduced doses of calcineurin inhibit...

What is the current status of trial NCT00117689?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2005-04. Estimated completion is 2007-12.

What conditions does trial NCT00117689 study?

This clinical trial studies the following conditions: Liver Dysfunction, Transplantation, Liver, Rejection, Transplant.

What interventions are being tested in trial NCT00117689?

The interventions under investigation include: Corticosteroid (DRUG), Mycophenolate Mofetil (DRUG), Tacrolimus (DRUG), Thymoglobulin (BIOLOGICAL).

Who is sponsoring clinical trial NCT00117689?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00117689 being conducted?

This trial has 16 study locations across Alabama, California, Colorado, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Liver Dysfunction

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.

Where NCT00117689's enrollment target sits among peer trials

75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00117689, the US trial registry maintained by the National Library of Medicine. NCT00117689 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.