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., June 2009

First Received: March 21, 2007 Last Updated: July 30, 2009 History of Changes

Sponsor:	Tolerx Inc.
Collaborator:	Juvenile Diabetes Research Foundation
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

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)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults 18 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

Contacts

Contact: Sophie Shen

(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.	Active, not recruiting
Walnut Creek, California, United States, 94598
United States, Colorado
Peter Gottlieb, M.D.	Recruiting
Aurora, Colorado, United States, 80045
United States, Illinois
Louis Philipson	Recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
Thomas Holohan, M. D.	Active, not recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
John Mordes, 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
Douglas Denham, M.D.	Active, not recruiting
San Antonio, Texas, United States, 78229
Canada, Ontario
Ronnie Aronson, M.D.	Active, not recruiting
Toronto, Ontario, Canada, M4R 2G4

Sponsors and Collaborators

Tolerx Inc.

Juvenile Diabetes Research Foundation

Investigators

Study Director:

Charlotte McKee, M.D.

Tolerx Inc.

More Information

Additional 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. ( Sophie Shen/Clinical Study Manager )
Study ID Numbers:	TRX4005
Study First Received:	March 21, 2007
Last Updated:	July 30, 2009
ClinicalTrials.gov Identifier:	NCT00451321 History of Changes
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

Additional relevant MeSH terms:

Antibodies, Monoclonal
Antibodies
Autoimmune Diseases
Metabolic Diseases
Immunologic Factors
Immune System Diseases

Diabetes Mellitus, Type 1
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009