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TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM) (TTEDD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00451321
First Posted: March 23, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters.

Condition Intervention Phase
Type 1 Diabetes Mellitus Drug: Otelixizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TRX4 Therapeutic Evaluation of Different Multi-Dose Regimens in Type 1 Diabetes Mellitus (TTEDD)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Define highest tolerated dose regimen that has negligible cytokine release, and no clinically significant reactivation of EBV. Evaluate effects of different dose regimens on safety parameters and EBV reactivation. [ Time Frame: up to 48 months ]

Enrollment: 100
Study Start Date: July 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: otelixizumab Drug: Otelixizumab
Infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 12 to 45 years old who are in good general health
  • Confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic control
  • Measurable C-peptide levels

Exclusion Criteria:

  • Females must not be pregnant or lactating and willing to practice contraception
  • No prior malignancy, other than non-melanoma skin cancer
  • Body Mass Index (BMI) > 32 at screening
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451321


Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
GSK Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
GSK Investigational Site
Aurora, Colorado, United States, 80045
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20037
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32207
GSK Investigational Site
Pinellas Park, Florida, United States, 33781
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
GSK Investigational Site
Worcester, Massachusetts, United States, 1655
United States, Michigan
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
GSK Investigational Site
Gulfport, Mississippi, United States, 39501
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68131
United States, Ohio
GSK Investigational Site
Mentor, Ohio, United States, 44060
United States, South Dakota
GSK Investigational Site
Rapid City, South Dakota, United States, 57701
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229-4801
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M4G 3E8
Sponsors and Collaborators
GlaxoSmithKline
Juvenile Diabetes Research Foundation
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00451321     History of Changes
Other Study ID Numbers: 115493
TRX4005 ( Other Identifier: Tolerx )
First Submitted: March 21, 2007
First Posted: March 23, 2007
Last Update Posted: October 12, 2017
Last Verified: July 2012

Keywords provided by GlaxoSmithKline:
type 1 diabetes mellitus
diabetes mellitus type 1
type 1 diabetes
diabetes mellitus
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases