Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria
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ClinicalTrials.gov Identifier: NCT00004398 |
Recruitment Status
:
Completed
First Posted
: October 19, 1999
Last Update Posted
: June 24, 2005
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Porphyria | Drug: heme arginate Drug: tin mesoporphyrin | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 24 participants |
Allocation: | Randomized |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | January 1998 |
Study Completion Date : | May 2000 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- Not pregnant
- Fertile female patients must use effective contraception during and 6 months before study
- No evidence that symptoms are due to another acute illness
- No acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage
- No known sensitivity to heme preparation or tin mesoporphyrin
- No other medical condition that might increase risk to patient

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004398
Study Chair: | Karl Elmo Anderson | University of Texas |
ClinicalTrials.gov Identifier: | NCT00004398 History of Changes |
Other Study ID Numbers: |
199/13191 UTMB-97-118 UTMB-FDR001459 |
First Posted: | October 19, 1999 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | June 2000 |
Keywords provided by Office of Rare Diseases (ORD):
inborn errors of metabolism porphyria rare disease |
Additional relevant MeSH terms:
Porphyrias Porphyria, Erythropoietic Metabolic Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases Tin mesoporphyrin Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |