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NCT00672204 · ClinicalTrials.gov registry record · Phase 1

Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes

A Phase 1 study, sponsored by University of Minnesota.

Terminated
Registry status
Phase 1
Development phase
23
Enrollment target

NCT00672204 is a Phase 1 study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 23 participants.

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The verdict

NCT00672204, a Phase 1 study, was terminated before completion, sponsored by University of Minnesota.

TERMINATED
Registry status
Phase 1
Development phase
23 participants
Enrollment target

Study Summary

The primary objective of this protocol is to test the safety and efficacy of a treatment regimen consisting of maintenance therapy with efalizumab and sirolimus for 1 year followed by withdrawal of efalizumab and maintenance therapy with sirolimus, for the prevention of the destruction and rejection of islet transplants in type 1 diabetic recipients. Genentech, the manufacturer of efalizumab voluntarily withdrew the drug from the U.S. market in April of 2009. Previously transplanted subjects have been transitioned to alternative immunosuppressives and no new subjects will be transplanted under this protocol.

Interventions

  • DRUG Sirolimus
  • DRUG anti-thymocyte globulin
  • DRUG Raptiva
  • BIOLOGICAL Allogeneic islets of Langerhans transplant

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2007-11
Est. Completion 2012-08
Phase Phase 1

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT00672204

The ClinicalTrials.gov registry entry for NCT00672204 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Sirolimus is the first listed.

NCT00672204 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00672204 about?

NCT00672204 is a clinical study titled "Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes". The primary objective of this protocol is to test the safety and efficacy of a treatment regimen consisting of maintenance therapy with efalizumab and sirolimus for 1 year followed by withdrawal of efalizumab and maintenance therapy with sirolimus, for the prevention of the destruction and rejection...

What is the current status of trial NCT00672204?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2007-11. Estimated completion is 2012-08.

What interventions are being tested in trial NCT00672204?

The interventions under investigation include: Sirolimus (DRUG), anti-thymocyte globulin (DRUG), Raptiva (DRUG), Allogeneic islets of Langerhans transplant (BIOLOGICAL).

Who is sponsoring clinical trial NCT00672204?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

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

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.