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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Texas |
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Information provided by: | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier: | NCT00004396 |
OBJECTIVES: I. Compare the efficacy of heme arginate, singly or in combination with tin mesoporphyrin, in lowering porphyrin precursors in patients with asymptomatic acute intermittent porphyria.
II. Evaluate and compare the safety and tolerability of these treatment regimens in this patient population.
Condition | Intervention | Phase |
---|---|---|
Porphyria |
Drug: heme arginate Drug: tin mesoporphyrin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Estimated Enrollment: | 32 |
Study Start Date: | September 1997 |
PROTOCOL OUTLINE: This is an unblinded, dose ranging study. Patients receive heme arginate alone or in combination with tin mesoporphyrin.
Patients receive tin mesoporphyrin IV as a single dose. Heme arginate is administered as a single intravenous infusion.
Patients are entered in cohorts of 4. Subsequent cohorts of 4 patients each receive escalating doses of tin mesoporphyrin in combination with 1 of 2 different dosages of heme arginate. Subjects must maintain a constant diet.
Patients experiencing adverse reactions are followed as clinically indicated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
United States, New York | |
Rockefeller University Hospital | |
New York, New York, United States, 10021-6399 | |
United States, Texas | |
University of Texas Medical Branch | |
Galveston, Texas, United States, 77555-0209 |
Study Chair: | Karl Elmo Anderson | University of Texas |
Study ID Numbers: | 199/13185, UTMB-96-476, UTMB-96-318, UTMB-FDR000710, UTMB-FDR001459 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004396 |
Health Authority: | United States: Federal Government |
inborn errors of metabolism porphyria rare disease |
Metabolic Diseases Porphyrias Skin Diseases Rare Diseases Porphyria, congenital erythropoietic Porphyria, Acute Intermittent Metabolism, Inborn Errors |
Tin mesoporphyrin Genetic Diseases, Inborn Acute intermittent porphyria Porphyria, Erythropoietic Metabolic disorder Skin Diseases, Genetic |
Molecular Mechanisms of Pharmacological Action Skin Diseases, Metabolic Enzyme Inhibitors Pharmacologic Actions |