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

This study has been completed.

Sponsor:

Collaborator:

University of Texas

Information provided by:

Office of Rare Diseases (ORD)

ClinicalTrials.gov Identifier:

NCT00004398

First received: October 18, 1999

Last updated: June 23, 2005

Last verified: June 2000

History of Changes

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 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: porphyria

MedlinePlus related topics: Porphyria

Genetic and Rare Diseases Information Center resources: Porphyria Congenital Erythropoietic Porphyria

U.S. FDA Resources

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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00004398 History of Changes
Other Study ID Numbers:	199/13191 UTMB-97-118 UTMB-FDR001459
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005

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

ClinicalTrials.gov processed this record on July 27, 2017

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