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COMPLETED Phase 2

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

NCT00117689 · View on ClinicalTrials.gov ↗

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

52 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00117689

The ClinicalTrials.gov registry entry for NCT00117689 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00117689 reports 16 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00117689?

The interventions under investigation include: Corticosteroid (DRUG), Mycophenolate Mofetil (DRUG), Tacrolimus (DRUG), Thymoglobulin (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00117689?

This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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