NCT00004396

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PROTOCOL OUTLINE: This is an unblinded, dose ranging study. Patients receive heme arginate alone or in combination with tin mesoporphyrin. Patients receive tin mesoporphyrin IV as a single dose. Heme arginate is administered as a single intravenous infusion. Patients are entered in cohorts of 4. Subsequent cohorts of 4 patients each receive escalating doses of tin mesoporphyrin in combination with 1 of 2 different dosages of heme arginate. Subjects must maintain a constant diet. Patients experiencing adverse reactions are followed as clinically indicated.

Conditions

• Porphyria

Interventions

Type	Name	Description
DRUG	heme arginate
DRUG	tin mesoporphyrin

Timeline

• Start date: 1997-09-01
• First posted: 1999-10-19
• Last updated: 2005-06-24

Locations

2 sites across 1 country: United States