Phase I Study of Tin Mesoporphyrin in Patients on Long Term Heme Therapy for Prevention of Acute Attacks of Porphyria
NCT ID: NCT00004397
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
PHASE1
20 participants
INTERVENTIONAL
1998-01-31
2000-05-31
Brief Summary
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II. Evaluate the safety and tolerability of tin mesoporphyrin in these patients.
Detailed Description
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Patients receive tin mesoporphyrin once a week for 6 months. Patients must avoid sunlight during treatment and for 2 months thereafter. The frequency of heme infusions is reduced by half and the frequency of attacks of porphyria is monitored.
Patients are followed for 6 months after last treatment.
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, variegate porphyria, or hereditary coproporphyria causing 6 or more attacks per year Fewer than 2 attacks in the preceding 6 months if already on preventive heme therapy --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Urinary porphobilinogen at least 20 mg/24 hours during acute symptoms Other: Not pregnant Fertile female patients must use effective contraception during and for 6 months prior to study No recurrent symptoms due to another illness No continuous (for longer than 1 month) symptoms of porphyria unless it is in addition to acute exacerbations No acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage No known hypersensitivity to tin mesoporphyrin No known hypersensitivity to any intravenous heme preparation No other condition which 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
Other Identifiers
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UTMB-97-117
Identifier Type: -
Identifier Source: secondary_id
UTMB-FDR001459
Identifier Type: -
Identifier Source: secondary_id
199/13187
Identifier Type: -
Identifier Source: org_study_id