Overview

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

Status:
Completed

Trial end date:
2007-03-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

AZ-VUB

Collaborators:

Erasme University Hospital
Katholieke Universiteit Leuven
KU Leuven
Universiteit Antwerpen

Treatments:

Antibodies
Antibodies, Monoclonal