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Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients

Clinical Trial Summary

Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical onset of disease that persists until 48 months after administration.

The investigators also hypothesize that in type 1 diabetic patients with recent clinical onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18 and 48 months after administration, based on assessment of clinical and laboratory adverse events.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00627146
Study type Interventional
Source AZ-VUB
Contact
Status Completed
Phase Phase 2
Start date June 2000
Completion date March 2007
View Details
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