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| 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 |
| 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) |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2006 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Eligibility
| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kathleen Osborn | (877) 515-6672 | clinicaltrials@tolerx.com |
| 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 | |||||
| Tolerx Inc. |
| Juvenile Diabetes Research Foundation (JDRF) |
| Study Director: | Charlotte McKee, M.D. | Tolerx Inc. |
More Information
Click here for more information on the TTEDD study 
  |
| 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 |
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