NCT00806572

Brief Summary

This is a phase II study to examine the clinical and immunological effects of humanized FcR non-binding anti-CD3 mAb in participants with Type 1 diabetes mellitus (T1DM), and to develop this therapy to prevent the immune destruction leading to β cell loss.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2002

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

December 9, 2008

Last Update Submit

February 6, 2017

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes, juvenile diabetes, teplizumab

Outcome Measures

Primary Outcomes (1)

  • 4-hour C-peptide AUC

    24 months

Secondary Outcomes (1)

  • Insulin usage

    throughout study

Study Arms (2)

Treatment

EXPERIMENTAL
Drug: hOKT3gamma1(Ala-Ala)

Control

NO INTERVENTION

Interventions

hOKT3gamma1(Ala-Ala)DRUG

3 cycles, six months apart, each consisting of 12 daily infusions with 455-1818ug/m2 hOKT3g1(Ala-Ala)

Also known as: teplizumab
Treatment

Eligibility Criteria

Age7 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diagnosed with T1DM within the past 6 weeks
  • have a body weight ≥26 kg at the time of enrollment
  • have detectable anti-GAD, anti-ICA512/IA-2, or insulin autoantibodies (if the participant has been on insulin ≤10 days).

You may not qualify if:

  • Pregnant or lactating females;
  • Prior OKT3 treatment;
  • Known hypersensitivity to murine products;
  • Uncompensated heart failure or fluid overload, recent myocardial infarction;
  • History of epilepsy, cancer, active infection, atopic disease, active Grave's disease, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease, cerebrovascular disease, any concurrent autoimmune diseases, asthma;
  • Any medical condition that in the opinion of the investigator will interfere with safe completion of the trial;
  • Inability to give informed consent;
  • Prior participation in a clinical trial that could potentially affect diabetes or immunologic status;
  • Participation in a clinical trial within the last 6 weeks;
  • HIV positive;
  • Positive for Hepatitis B surface antigen or Anti-Hepatitis C antibody;
  • Seropositivity for Toxoplasmosis (IgG);
  • Lymphopenia (\<1000 lymphocytes/microliter);
  • Thrombocytopenia (\<150,000/mm3 platelets);
  • Anemia (Hgb \< 10g/dL);
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Naomie Berrie Diabetes Center, Columbia University

New York, New York, 10032, United States

Location

Benaroya Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • Herold KC, Gitelman S, Greenbaum C, Puck J, Hagopian W, Gottlieb P, Sayre P, Bianchine P, Wong E, Seyfert-Margolis V, Bourcier K, Bluestone JA; Immune Tolerance Network ITN007AI Study Group. Treatment of patients with new onset Type 1 diabetes with a single course of anti-CD3 mAb Teplizumab preserves insulin production for up to 5 years. Clin Immunol. 2009 Aug;132(2):166-73. doi: 10.1016/j.clim.2009.04.007. Epub 2009 May 14.

    PMID: 19443276RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

teplizumab

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kevan C Herold, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2008

First Posted

December 11, 2008

Study Start

May 1, 2002

Primary Completion

July 1, 2004

Study Completion

August 1, 2007

Last Updated

February 8, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Data access is provided to the public in Participant level data and additional relevant materials are available to the public in : 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools available to researchers; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal that makes data from the consortium's clinical trials publicly available.

Available IPD Datasets

Individual Participant Data Set (ITN007AI-NDB01)Access
Study protocol synopsis, -navigator, -schedule of events,-data &reports, -specimens et al. (ITN007AI-NDB01)Access
Individual Participant Data Set (SDY569)Access
Study summary, -design, -medications, -demographics, -lab tests, and -files. (SDY569)Access

Locations

US(3)