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Sponsors and Collaborators: |
Tolerx Inc. Juvenile Diabetes Research Foundation |
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Information provided by: | Tolerx Inc. |
ClinicalTrials.gov Identifier: | NCT00451321 |
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 |
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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) |
Estimated Enrollment: | 100 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sophie Shen | (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. | 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 | |
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. | Active, not recruiting |
San Antonio, Texas, United States, 78229 | |
Canada, Ontario | |
Ronnie Aronson, M.D. | Active, not recruiting |
Toronto, Ontario, Canada, M4R 2G4 |
Study Director: | Charlotte McKee, M.D. | Tolerx Inc. |
Responsible Party: | Tolerx, Inc. ( Sophie Shen/Clinical Study Manager ) |
Study ID Numbers: | TRX4005 |
Study First Received: | March 21, 2007 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00451321 |
Health Authority: | United States: Food and Drug Administration |
diabetes type 1 diabetes diabetes mellitus diabetes mellitus type 1 type 1 diabetes mellitus |
Antibodies, Monoclonal Antibodies Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Immunoglobulins |
Immunologic Factors Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |