drugset / Trial / NCT00004789
Phase I/II Study of Heme Arginate and Tin Mesoporphyrin for Acute Porphyria
Phase 1/2
Completed
59 enrolled
National Center for Research Resources (NCRR)
University of Texas · collab
Treatment
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.
Timeline
- Start
- 1993-07
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | heme arginate | Small molecule | 0.3 mg/kg | Intravenous |
| Subject | heme arginate | Small molecule | 1 mg/kg | Intravenous |
| Subject | heme arginate | Small molecule | 3 mg/kg | Intravenous |
| Subject | stannsoporfin | Small molecule | — | — |