Status:
COMPLETED
Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients
Lead Sponsor:
AZ-VUB
Collaborating Sponsors:
KU Leuven
Universiteit Antwerpen
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
12-45 years
Phase:
PHASE2
Brief 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 tha...
Eligibility Criteria
Inclusion
- Subjects with Type 1 diabetes mellitus included in the phase II therapeutic trial with a humanized non-mitogenic CD3 monoclonal antibody (ChAgly CD3) at time of clinical diagnosis and who agree and are likely to comply with the investigator's instructions
Exclusion
- Any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient
- Use of illicit drugs or over consumption of alcohol (\> 3 beers/day)
- Being legally incapacitated, having significant emotional problems at the time of the study
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00627146
Start Date
June 1 2000
End Date
March 1 2007
Last Update
September 29 2008
Active Locations (5)
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1
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
2
Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
Brussels, Belgium, 1090
3
Hopital Erasme
Brussels, Belgium
4
Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
Leuven, Belgium, 3000