TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM) - Full Text View

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

This study is currently recruiting participants.
Verified by Tolerx Inc., February 2008

Sponsors and Collaborators:	Tolerx Inc. Juvenile Diabetes Research Foundation (JDRF)
Information provided by:	Tolerx Inc.
ClinicalTrials.gov Identifier:	NCT00451321

Purpose

The purpose of this study is to optimize several multi-dose regimens of TRX4, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of TRX4 against standard safety and efficacy parameters.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus	Drug: TRX4 monoclonal antibody	Phase II

MedlinePlus related topics:

Diabetes Diabetes Type 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment

Official Title:	TRX4 Therapeutic Evaluation of Different Multi-Dose Regimens in Type 1 Diabetes Mellitus (TTEDD)

Further study details as provided by Tolerx Inc.:

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: varied ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	September 2006
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Infusion

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults 18 to 60 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) > 34 at screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451321

Contacts


Contact: Kathleen Osborn	(877) 515-6672	clinicaltrials@tolerx.com

Locations


United States, Alabama
	Fernando Ovalle, M.D.	Recruiting
	Birmingham, Alabama, United States, 35294

United States, California
	Richard Weinstein, M. D.	Recruiting
	Walnut Creek, California, United States, 94598

United States, Colorado
	Peter Gottlieb, M.D.	Recruiting
	Aurora, Colorado, United States, 80045

United States, Maryland
	Thomas Holohan, M. D.	Active, not recruiting
	Baltimore, Maryland, United States, 21201

United States, Massachusetts
	Michael Thompson, M.D.	Recruiting
	Worcester, Massachusetts, United States, 01655

United States, Mississippi
	Stanford Owen, M. D.	Active, not recruiting
	Gulfport, Mississippi, United States, 39501

United States, New York
	Steven Wittlin, M.D.	Recruiting
	Rochester, New York, United States, 14627

United States, Texas
	Mark Kipnes, M.D.	Recruiting
	San Antonio, Texas, United States, 78229

Canada, Ontario
	Ronnie Aronson, M.D.	Recruiting
	Toronto, Ontario, Canada, M4R 2G4

Sponsors and Collaborators

Tolerx Inc.

Juvenile Diabetes Research Foundation (JDRF)

Investigators


Study Director:	Charlotte McKee, M.D.	Tolerx Inc.

More Information

Click here for more information on the TTEDD study This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Tolerx, Inc. ( Kathleen Osborn/Clinical Study Manager )
Study ID Numbers:	TRX4005
First Received:	March 21, 2007
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00451321
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tolerx Inc.:

diabetes

type 1 diabetes

diabetes mellitus

diabetes mellitus type 1

type 1 diabetes mellitus

Study placed in the following topic categories:

Antibodies, Monoclonal

Antibodies

Autoimmune Diseases

Metabolic Diseases

Diabetes Mellitus, Type 1

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Additional relevant MeSH terms:

Immunologic Factors

Immune System Diseases

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008