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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

This study has been completed.
Sponsor:
Collaborators:
Katholieke Universiteit Leuven
Universiteit Antwerpen
Erasme University Hospital
Information provided by:
AZ-VUB
ClinicalTrials.gov Identifier:
NCT00627146
First received: February 22, 2008
Last updated: September 25, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: ChAgly CD3
Drug: Placebo
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AZ-VUB:

Primary Outcome Measures:
  • The difference in change in daily insulin need between baseline and month 48, between placebo and ChAgly CD3 treated patients [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: June 2000
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: B Drug: Placebo
6 days
Active Comparator: A
ChAgly CD3
 Drug: ChAgly CD3
6 days treatment 8mg/d intravenous

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627146

Locations
Belgium
Universitair Ziekenhuis Antwerpen
Antwerpen, Belgium
Hopital Erasme
Brussel, Belgium
Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
Brussels, Belgium, 1090
Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
Leuven, Belgium, 3000
Germany
Hopital Schwabbing
Munich, Germany
Sponsors and Collaborators
AZ-VUB
Katholieke Universiteit Leuven
Universiteit Antwerpen
Erasme University Hospital
Investigators
Principal Investigator: Bart Keymeulen, MD,PhD Universitair Ziekenhuis Brussel
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bart Keymeulen, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00627146     History of Changes
Other Study ID Numbers: BK-AntiCD3-02
Study First Received: February 22, 2008
Last Updated: September 25, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by AZ-VUB:
Diabetes Mellitus, type 1
ChAgly CD3

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013