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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00004396 |
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Date of registration:
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18/10/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Studies in Porphyria III: Heme and Tin Mesoporphyrin in Acute Porphyrias
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Scientific title:
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Date of first enrolment:
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September 1997 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00004396 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Karl Elmo Anderson |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Texas |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Porphyria
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Intervention(s)
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Drug: heme arginate
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Drug: tin mesoporphyrin
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Secondary ID(s)
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UTMB-FDR000710
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UTMB-96-318
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UTMB-FDR001459
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199/13185
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UTMB-96-476
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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