Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria
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.
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Study Start Date:||January 1998|
|Estimated Study Completion Date:||May 2000|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004398
|Study Chair:||Karl Elmo Anderson||University of Texas|