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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 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. The trial reports 16 study locations across 13 states.

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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

Sponsor

Genzyme, a Sanofi Company

196 total trials

What the Registry Record Tells You About NCT00117689

The ClinicalTrials.gov registry entry for NCT00117689 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.

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 reports 16 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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