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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

NCT ID: NCT00627146

Last Updated: 2008-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Keywords

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Diabetes Mellitus, type 1 ChAgly CD3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

6 days

A

ChAgly CD3

Group Type ACTIVE_COMPARATOR

ChAgly CD3

Intervention Type DRUG

6 days treatment 8mg/d intravenous

Interventions

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ChAgly CD3

6 days treatment 8mg/d intravenous

Intervention Type DRUG

Placebo

6 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role collaborator

Erasme University Hospital

OTHER

Sponsor Role collaborator

AZ-VUB

OTHER

Sponsor Role lead

Responsible Party

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Universitair Ziekenhuis Brussel

Principal Investigators

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Bart Keymeulen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

Site Status

Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB

Brussels, , Belgium

Site Status

Hopital Erasme

Brussels, , Belgium

Site Status

Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL

Leuven, , Belgium

Site Status

Hopital Schwabbing

Munich, , Germany

Site Status

Countries

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Belgium Germany

References

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Keymeulen B, Vandemeulebroucke E, Ziegler AG, Mathieu C, Kaufman L, Hale G, Gorus F, Goldman M, Walter M, Candon S, Schandene L, Crenier L, De Block C, Seigneurin JM, De Pauw P, Pierard D, Weets I, Rebello P, Bird P, Berrie E, Frewin M, Waldmann H, Bach JF, Pipeleers D, Chatenoud L. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med. 2005 Jun 23;352(25):2598-608. doi: 10.1056/NEJMoa043980.

Reference Type BACKGROUND
PMID: 15972866 (View on PubMed)

Keymeulen B, Walter M, Mathieu C, Kaufman L, Gorus F, Hilbrands R, Vandemeulebroucke E, Van de Velde U, Crenier L, De Block C, Candon S, Waldmann H, Ziegler AG, Chatenoud L, Pipeleers D. Four-year metabolic outcome of a randomised controlled CD3-antibody trial in recent-onset type 1 diabetic patients depends on their age and baseline residual beta cell mass. Diabetologia. 2010 Apr;53(4):614-23. doi: 10.1007/s00125-009-1644-9. Epub 2010 Jan 14.

Reference Type DERIVED
PMID: 20225393 (View on PubMed)

Other Identifiers

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BK-AntiCD3-02

Identifier Type: -

Identifier Source: org_study_id