Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria

National Center for Research Resources (NCRR)24 enrolled

Overview

OBJECTIVES: I. Evaluate the efficacy of tin mesoporphyrin in patients with acute porphyria attacks who are also treated with a standard course of heme arginate. II. Evaluate the safety and tolerability of tin mesoporphyrin when administered to these patients.

PROTOCOL OUTLINE: This is an randomized, unblinded, multicenter study. Patients are randomized to receive heme arginate alone or both heme arginate and tin mesoporphyrin. Patients receive a single intravenous dose of tin mesoporphyrin immediately before the first dose of heme arginate. Heme arginate is administered daily for 4 days. Patients are followed at 3 and 6 days after treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Porphyria

Interventions

heme arginateDRUG

tin mesoporphyrinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented acute intermittent porphyria, variegate porphyria, or hereditary coproporphyria No chronic or subacute symptoms (present for longer than 2 weeks) --Prior/Concurrent Therapy-- At least 3 weeks since prior treatment with heme arginate or tin mesoporphyrin --Patient Characteristics-- Renal: Urinary porphobilinogen at least 40 mg/24 hr Other: * Not pregnant * Fertile female patients must use effective contraception during and 6 months before study * No evidence that symptoms are due to another acute illness * No acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage * No known sensitivity to heme preparation or tin mesoporphyrin * No other medical condition that might increase risk to patient

Data from ClinicalTrials.gov

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