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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: University of Texas
• Treatments: Tin mesoporphyrin

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