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

This study has been completed.

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of Texas
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004398

Purpose

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	Intervention	Phase
Porphyria	Drug: heme arginate Drug: tin mesoporphyrin	Phase I

Genetics Home Reference related topics: porphyria

MedlinePlus related topics: Porphyria

Drug Information available for: Tin mesoporphyrin Heme arginate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	24
Study Start Date:	January 1998
Estimated Study Completion Date:	May 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004398

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Texas

Investigators

Study Chair:

Karl Elmo Anderson

University of Texas

More Information

Study ID Numbers:	199/13191, UTMB-97-118, UTMB-FDR001459
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004398
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

inborn errors of metabolism
porphyria
rare disease

Study placed in the following topic categories:

Metabolism, Inborn Errors
Tin mesoporphyrin
Metabolic Diseases
Skin Diseases
Genetic Diseases, Inborn
Porphyrias

Rare Diseases
Porphyria, congenital erythropoietic
Metabolic disorder
Porphyria, Erythropoietic
Skin Diseases, Genetic

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Skin Diseases, Metabolic
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009