Studies in Porphyria III: Heme and Tin Mesoporphyrin in Acute Porphyrias
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Study Start Date:||September 1997|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004396
|United States, New York|
|Rockefeller University Hospital|
|New York, New York, United States, 10021-6399|
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555-0209|
|Study Chair:||Karl Elmo Anderson||University of Texas|