Phase I Study of Tin Mesoporphyrin in Patients on Long Term Heme Therapy for Prevention of Acute Attacks of Porphyria
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|ClinicalTrials.gov Identifier: NCT00004397|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Porphyria||Drug: heme arginate Drug: tin mesoporphyrin||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Study Start Date :||January 1998|
|Estimated Study Completion Date :||May 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004397
|Study Chair:||Karl Elmo Anderson||University of Texas|