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Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria

Porphyria Clinical Trial

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004398
Study type Interventional
Source Office of Rare Diseases (ORD)
Contact
Status Completed
Phase Phase 1
Start date January 1998
Completion date May 2000
View Details
See also
  Status Clinical Trial Phase
Completed NCT00004396 - Studies in Porphyria III: Heme and Tin Mesoporphyrin in Acute Porphyrias Phase 2
Recruiting NCT00004331 - Studies in Porphyria I: Characterization of Enzyme Defects N/A
Completed NCT00004788 - Study of Nutritional Factors in Porphyria N/A
Completed NCT00004330 - Studies in Porphyria IV: Gonadotropin-Releasing Hormone (GnRH) Analogues for Prevention of Cyclic Attacks N/A
Completed NCT00004789 - Phase I/II Study of Heme Arginate and Tin Mesoporphyrin for Acute Porphyria Phase 1/Phase 2
Completed NCT00004397 - Phase I Study of Tin Mesoporphyrin in Patients on Long Term Heme Therapy for Prevention of Acute Attacks of Porphyria Phase 1