Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria

Study Description

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Brief Summary:

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

Detailed Description:

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 Design

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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

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Texas

Investigators

Study Chair:	Karl Elmo Anderson	University of Texas

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00004398 History of Changes
Other Study ID Numbers:	199/13191; UTMB-97-118; UTMB-FDR001459
First Posted:	October 19, 1999
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