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

Tracking Information

First Received Date ^ICMJE

March 21, 2007

Last Updated Date

July 30, 2009

Start Date ^ICMJE

September 2006

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00451321 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment

Condition ^ICMJE

Type 1 Diabetes Mellitus

Intervention ^ICMJE

Drug: TRX4 monoclonal antibody

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sophie Shen

(877) 515-6672

clinicaltrials@tolerx.com

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00451321

Responsible Party

Sophie Shen/Clinical Study Manager, Tolerx, Inc.

Study ID Numbers ^ICMJE

TRX4005

Study Sponsor ^ICMJE

Tolerx Inc.

Collaborators ^ICMJE

Juvenile Diabetes Research Foundation

Investigators ^ICMJE

Study Director:

Charlotte McKee, M.D.

Tolerx Inc.

Information Provided By

Tolerx Inc.

Verification Date

June 2009

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