Completed

Heme Arginate and Tin Mesoporphyrin for Acute Attacks of Porphyria

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What is being tested

heme arginate

+ tin mesoporphyrin

Drug
Who is being recruted

Metabolic Diseases+7

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

+ Nutritional and Metabolic Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 1998
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00004398
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Metabolic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesGenetic Diseases, InbornMetabolism, Inborn ErrorsPorphyriasRare Diseases

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented acute intermittent porphyria, variegate porphyria, or hereditary coproporphyria No chronic or subacute symptoms (present for longer than 2 weeks) --Prior/Concurrent Therapy-- At least 3 weeks since prior treatment with heme arginate or tin mesoporphyrin --Patient Characteristics-- Renal: Urinary porphobilinogen at least 40 mg/24 hr Other: Not pregnant Fertile female patients must use effective contraception during and 6 months before study No evidence that symptoms are due to another acute illness No acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage No known sensitivity to heme preparation or tin mesoporphyrin No other medical condition that might 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.
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CompletedNo study centers