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| ID | Type | Description | Link |
|---|---|---|---|
| UTMB-97-118 | |||
| UTMB-FDR001459 |
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| Name | Class |
|---|---|
| University of Texas | OTHER |
OBJECTIVES: I. Evaluate the efficacy of tin mesoporphyrin in patients with acute porphyria attacks who are also treated with a standard course of heme arginate.
II. Evaluate the safety and tolerability of tin mesoporphyrin when administered to these patients.
PROTOCOL OUTLINE: This is an randomized, unblinded, multicenter study. Patients are randomized to receive heme arginate alone or both heme arginate and tin mesoporphyrin.
Patients receive a single intravenous dose of tin mesoporphyrin immediately before the first dose of heme arginate. Heme arginate is administered daily for 4 days.
Patients are followed at 3 and 6 days after treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heme arginate | Drug | |||
| tin mesoporphyrin | Drug |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Documented acute intermittent porphyria, variegate porphyria, or hereditary coproporphyria
No chronic or subacute symptoms (present for longer than 2 weeks)
--Prior/Concurrent Therapy--
At least 3 weeks since prior treatment with heme arginate or tin mesoporphyrin
--Patient Characteristics--
Renal: Urinary porphobilinogen at least 40 mg/24 hr
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Karl Elmo Anderson | University of Texas | Study Chair |
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| ID | Term |
|---|---|
| D011164 | Porphyrias |
| D008661 | Metabolism, Inborn Errors |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C048849 | heme arginate |
| C055421 | tin mesoporphyrin |
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| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |