Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00378508

Run by

Yale University

People needed

63

Starts

2006-09-01

Expected to finish

2013-08-01

Last updated by the study team

2021-08-13

Who can join

Age: 8 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age 8 - 30,
• duration of diabetes 4 - 12 months,
• weight greater than 27.5 kg,
• stimulated C-peptide >= 0.2 pmol/ml

You may not qualify if…

• asthma,
• history of hepatitis C, hepatitis B, HIV

Where it is running

• University of California at San Francisco — San Francisco, California, United States
• Barbara Davis Diabetes Center — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Children's Hospital of Philadelphia (CHOP) — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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