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TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM) (TTEDD)
This study is ongoing, but not recruiting participants.
Study NCT00451321   Information provided by GlaxoSmithKline

First Received on March 21, 2007.   Last Updated on October 6, 2011   History of Changes

March 21, 2007
October 6, 2011
July 2006
April 2014   (final data collection date for primary outcome measure)
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 ]
Define highest tolerated dose regimen of TRX4 that has negligible cytokine release after each dose, and no clinically significant reactivation of EBV. Evaluate effects of different dose regimens of TRX4 on safety parameters and EBV reactivation. [ Time Frame: varied ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00451321 on ClinicalTrials.gov Archive Site
 
 
 
TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)
TRX4 Therapeutic Evaluation of Different Multi-Dose Regimens in Type 1 Diabetes Mellitus (TTEDD)

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.
 
Interventional
Phase II
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
Drug: Otelixizumab
Infusion
Experimental: otelixizumab
Intervention: Drug: Otelixizumab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
12 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00451321
115493, TRX4005
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Juvenile Diabetes Research Foundation
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP




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