Studies in Porphyria III: Heme and Tin Mesoporphyrin in Acute Porphyrias
NCT ID: NCT00004396
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
1997-09-30
Brief Summary
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II. Evaluate and compare the safety and tolerability of these treatment regimens in this patient population.
Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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heme arginate
tin mesoporphyrin
Eligibility Criteria
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Inclusion 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
18 Years
ALL
No
Sponsors
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University of Texas
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
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Karl Elmo Anderson
Role: STUDY_CHAIR
University of Texas
Locations
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Rockefeller University Hospital
New York, New York, United States
University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Other Identifiers
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UTMB-96-476
Identifier Type: -
Identifier Source: secondary_id
UTMB-96-318
Identifier Type: -
Identifier Source: secondary_id
UTMB-FDR000710
Identifier Type: -
Identifier Source: secondary_id
UTMB-FDR001459
Identifier Type: -
Identifier Source: secondary_id
199/13185
Identifier Type: -
Identifier Source: org_study_id