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

Fecha de inicio: 1 de septiembre de 1997

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