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Clinical Trial Summary

OBJECTIVES: I. Evaluate the effectiveness of tin mesoporphyrin in reducing the number of heme infusions needed to prevent acute attacks of porphyria.

II. Evaluate the safety and tolerability of tin mesoporphyrin in these patients.


Clinical Trial Description

PROTOCOL OUTLINE: This is an unblinded study. Patients start a preventive heme regimen and are followed for 6 months prior to tin mesoporphyrin. The frequency of attacks is recorded.

Patients receive tin mesoporphyrin once a week for 6 months. Patients must avoid sunlight during treatment and for 2 months thereafter. The frequency of heme infusions is reduced by half and the frequency of attacks of porphyria is monitored.

Patients are followed for 6 months after last treatment. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00004397
Study type Interventional
Source Office of Rare Diseases (ORD)
Contact
Status Completed
Phase Phase 1
Start date January 1998
Completion date May 2000

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 NCT00004398 - Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria Phase 1