Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria
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|ClinicalTrials.gov Identifier: NCT00004398|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Porphyria||Drug: heme arginate Drug: tin mesoporphyrin||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Masking:||None (Open Label)|
|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): NCT00004398
|Study Chair:||Karl Elmo Anderson||University of Texas|