- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004396
Studies in Porphyria III: Heme and Tin Mesoporphyrin in Acute Porphyrias
OBJECTIVES: I. Compare the efficacy of heme arginate, singly or in combination with tin mesoporphyrin, in lowering porphyrin precursors in patients with asymptomatic acute intermittent porphyria.
II. Evaluate and compare the safety and tolerability of these treatment regimens in this patient population.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10021-6399
- Rockefeller University Hospital
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Texas
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Galveston, Texas, United States, 77555-0209
- University of Texas Medical Branch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/13185
- UTMB-FDR001459
- UTMB-96-476
- UTMB-96-318
- UTMB-FDR000710
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Porphyria
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University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsCompletedAcute Intermittent Porphyria (AIP) | Hereditary Coproporphyria (HCP) | Variegate Porphyria (VP)United States
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The University of Texas Medical Branch, GalvestonTerminatedHereditary Coproporphyria | Acute Intermittent Porphyria | Variegate PorphyriaUnited States
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Alnylam PharmaceuticalsTerminatedAcute Hepatic Porphyria | Acute Intermittent Porphyria (AIP) | Hereditary Coproporphyria (HCP) | Variegate Porphyria (VP) | ALA Dehydratase Deficient Porphyria (ADP) | Hepatic Porphyrias | Porphyria AcuteUnited States
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Alnylam PharmaceuticalsCompletedAcute Hepatic Porphyria | Acute Intermittent Porphyria | Porphyria, Acute Intermittent | Acute Porphyria | Hereditary Coproporphyria (HCP) | Variegate Porphyria (VP) | ALA Dehydratase Deficient Porphyria (ADP)United States, Spain, United Kingdom, Korea, Republic of, Australia, Bulgaria, Canada, Denmark, Finland, France, Germany, Italy, Japan, Mexico, Netherlands, Poland, Sweden, Taiwan
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Alnylam PharmaceuticalsCompletedPorphyria, Acute Intermittent | Acute Intermittent Porphyria (AIP) | Acute Hepatic Porphyria (AHP) | Acute PorphyriaSweden
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The University of Texas Medical Branch, GalvestonActive, not recruitingHereditary Coproporphyria | Acute Intermittent Porphyria | Variegate PorphyriaUnited States
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Icahn School of Medicine at Mount SinaiRecruitingAcute Intermittent Porphyria (AIP)United States
-
University of Texas Southwestern Medical CenterNovartis PharmaceuticalsCompletedPorphyria Cutanea TardaUnited States
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Alnylam PharmaceuticalsCompletedAcute Intermittent PorphyriaUnited States, United Kingdom, Sweden
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Zymenex A/SCompleted
Clinical Trials on tin mesoporphyrin
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National Center for Research Resources (NCRR)University of TexasCompleted
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Eunice Kennedy Shriver National Institute of Child...Rockefeller UniversityCompletedHyperbilirubinemia | Glucosephosphate Dehydrogenase Deficiency | Hemolytic Disease of NewbornUnited States
-
InfaCare Pharmaceuticals Corporation, a Mallinckrodt...No longer availableHyperbilirubinemia | Neonatal JaundiceUnited States
-
Eunice Kennedy Shriver National Institute of Child...Rockefeller UniversityCompleted
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National Center for Research Resources (NCRR)University of TexasCompleted
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National Center for Research Resources (NCRR)University of TexasCompleted
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InfaCare Pharmaceuticals Corporation, a Mallinckrodt...Terminated
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InfaCare Pharmaceuticals Corporation, a Mallinckrodt...Completed
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InfaCare Pharmaceuticals Corporation, a Mallinckrodt...National Children's Hospital, VietnamCompleted
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InfaCare Pharmaceuticals Corporation, a Mallinckrodt...CompletedHyperbilirubinemia, Neonatal