Porphyria Clinical Trial
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.
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.
;
Primary Purpose: Treatment
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 |