Phase I/II Study of Heme Arginate and Tin Mesoporphyrin for Acute Porphyria
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
OBJECTIVES: I. Evaluate the efficacy and safety of heme arginate in the treatment of 20
patients with acute attacks of porphyria.
II. Evaluate the efficacy and safety of heme arginate in preventing frequent exacerbations of
acute porphyria in up to 15 patients.
III. Estimate the lowest effective dose of heme arginate (0.3, 1.0, or 3.0 mg/kg) in reducing
porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission.
IV. Evaluate the safety and efficacy of tin mesoporphyrin used in combination with heme
arginate in reducing porphyrin precursors in 12 stable patients with acute intermittent
porphyria in remission.