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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

NCT00627146 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2008-09-29

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

ChAgly CD3

6 days treatment 8mg/d intravenous

DRUG

Placebo

6 days

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Universiteit Antwerpen

    collaborator OTHER

  • Erasme University Hospital

    collaborator OTHER

  • AZ-VUB

    lead OTHER

Principal Investigators

  • Bart Keymeulen, MD,PhD · Universitair Ziekenhuis Brussel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-06-30
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • Belgium
  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00627146 on ClinicalTrials.gov