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NCT00378508 · ClinicalTrials.gov registry record · Phase 2

Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes

A Phase 2 study, sponsored by Yale University.

Completed
Registry status
Phase 2
Development phase
63
Enrollment target

NCT00378508 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 63 participants.

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The verdict

NCT00378508, a Phase 2 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 2
Development phase
63 participants
Enrollment target

Study Summary

This is a randomized placebo controlled study to test whether a single 14 course of treatment with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration since diagnosis.

Interventions

  • DRUG Placebo Arm
  • DRUG mAb hOKT3gamma1(Ala-Ala), Teplizumab

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2006-09
Est. Completion 2013-08
Phase Phase 2

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT00378508

The ClinicalTrials.gov registry entry for NCT00378508 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo Arm is the first listed.

NCT00378508 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00378508 about?

NCT00378508 is a clinical study titled "Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes". This is a randomized placebo controlled study to test whether a single 14 course of treatment with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration since diagnosis.

What is the current status of trial NCT00378508?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2006-09. Estimated completion is 2013-08.

What interventions are being tested in trial NCT00378508?

The interventions under investigation include: Placebo Arm (DRUG), mAb hOKT3gamma1(Ala-Ala), Teplizumab (DRUG).

Who is sponsoring clinical trial NCT00378508?

This trial is sponsored by Yale University, which has 1,492 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.