Heme Argentate and Tin Mesoporphyrin for Acute Porphyrias
heme arginate
+ tin mesoporphyrin
Metabolic Diseases+7
+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
Study start date: September 1, 1997
Actual date on which the first participant was enrolled.PROTOCOL OUTLINE: This is an unblinded, dose ranging study. Patients receive heme arginate alone or in combination with tin mesoporphyrin. Patients receive tin mesoporphyrin IV as a single dose. Heme arginate is administered as a single intravenous infusion. Patients are entered in cohorts of 4. Subsequent cohorts of 4 patients each receive escalating doses of tin mesoporphyrin in combination with 1 of 2 different dosages of heme arginate. Subjects must maintain a constant diet. Patients experiencing adverse reactions are followed as clinically indicated.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented acute intermittent porphyria in remission for at least 1 month Increased excretion of porphyrin precursors Absence of neurovisceral symptoms due to porphyria for at least 1 month --Prior/Concurrent Therapy-- At least 1 month since prior heme preparation therapy Concurrent medication for coexisting condition is allowed, as long as dose and pattern of administration is held constant during study --Patient Characteristics-- Renal: Urinary porphobilinogen excretion of at least 20 mg every 24 hours Other: Not pregnant Fertile female patients must use effective contraception during and at least 6 months before study At least 1 month since any symptoms of disease No concurrent acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage No known hypersensitivity to heme arginate, tin mesoporphyrin, another heme preparation, or related heme analogue No other condition that may increase risk to patient
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Rockefeller University Hospital
New York, United StatesOpen Rockefeller University Hospital in Google MapsUniversity of Texas Medical Branch
Galveston, United States