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NCT00468442 · ClinicalTrials.gov registry record · Phase 2

B-Lymphocyte Immunotherapy in Islet Transplantation

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Terminated
Registry status
Phase 2
Development phase
2
Enrollment target

NCT00468442 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2 participants.

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The verdict

NCT00468442, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

TERMINATED
Registry status
Phase 2
Development phase
2 participants
Enrollment target

Study Summary

Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with the immunosuppressive medications and medications to support islet survival for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.

Interventions

  • DRUG Sirolimus
  • BIOLOGICAL Rituximab
  • BIOLOGICAL Allogeneic Pancreatic Islet Cells
  • BIOLOGICAL Antithymocyte globulin
  • BIOLOGICAL Daclizumab

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2006-11
Est. Completion 2011-09
Phase Phase 2

What the Registry Record Tells You About NCT00468442

The ClinicalTrials.gov registry entry for NCT00468442 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Sirolimus is the first listed.

NCT00468442 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00468442 about?

NCT00468442 is a clinical study titled "B-Lymphocyte Immunotherapy in Islet Transplantation". Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with the immunosuppressive medications and med...

What is the current status of trial NCT00468442?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2006-11. Estimated completion is 2011-09.

What interventions are being tested in trial NCT00468442?

The interventions under investigation include: Sirolimus (DRUG), Rituximab (BIOLOGICAL), Allogeneic Pancreatic Islet Cells (BIOLOGICAL), Antithymocyte globulin (BIOLOGICAL), Daclizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00468442?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 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.