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

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00451321
First received: March 21, 2007
Last updated: November 15, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 21, 2007
Last Updated: November 15, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013