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Studies in Porphyria III: Heme and Tin Mesoporphyrin in Acute Porphyrias

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ClinicalTrials.gov Identifier: NCT00004396
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
University of Texas
Information provided by:
National Center for Research Resources (NCRR)

Study Description
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Brief Summary:

OBJECTIVES: I. Compare the efficacy of heme arginate, singly or in combination with tin mesoporphyrin, in lowering porphyrin precursors in patients with asymptomatic acute intermittent porphyria.

II. Evaluate and compare the safety and tolerability of these treatment regimens in this patient population.


Condition or disease Intervention/treatment Phase
Porphyria Drug: heme arginate Drug: tin mesoporphyrin Phase 2

Detailed Description:

PROTOCOL OUTLINE: This is an unblinded, dose ranging study. Patients receive heme arginate alone or in combination with tin mesoporphyrin.

Patients receive tin mesoporphyrin IV as a single dose. Heme arginate is administered as a single intravenous infusion.

Patients are entered in cohorts of 4. Subsequent cohorts of 4 patients each receive escalating doses of tin mesoporphyrin in combination with 1 of 2 different dosages of heme arginate. Subjects must maintain a constant diet.

Patients experiencing adverse reactions are followed as clinically indicated.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Primary Purpose: Treatment
Study Start Date : September 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Porphyria
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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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 in remission for at least 1 month
  • Increased excretion of porphyrin precursors
  • Absence of neurovisceral symptoms due to porphyria for at least 1 month

--Prior/Concurrent Therapy--

  • At least 1 month since prior heme preparation therapy
  • Concurrent medication for coexisting condition is allowed, as long as dose and pattern of administration is held constant during study

--Patient Characteristics--

  • Renal: Urinary porphobilinogen excretion of at least 20 mg every 24 hours
  • Other: Not pregnant Fertile female patients must use effective contraception during and at least 6 months before study At least 1 month since any symptoms of disease No concurrent acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage No known hypersensitivity to heme arginate, tin mesoporphyrin, another heme preparation, or related heme analogue No other condition that may increase risk to patient
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00004396


Locations
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021-6399
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
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: NCT00004396     History of Changes
Other Study ID Numbers: 199/13185
UTMB-96-476
UTMB-96-318
UTMB-FDR000710
UTMB-FDR001459
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
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