Evidence-based Assessment of Medication Sensitivity in Acute Hepatic Porphyria
NCT ID: NCT03906214
Last Updated: 2019-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2019-04-03
2019-09-13
Brief Summary
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Detailed Description
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If the registrant wants to participate in the study, he/she will follow the survey link in the email invitation, which directs him/her to an IRB-approved online consent form. If the participant consents to participate, he/she will be directed to online forms to report general information (ex. age, sex, test results, family history), suspected medication-related acute attacks, and "uneventful use of possibly risky medication". If a patient has multiple medication-related acute attacks, the patient/caregiver will be able to submit multiple report forms that will be linked. In addition to the report forms, patients will be asked to review a list of "Medications of Interest" and report current or past use.
Conditions
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Study Design
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OTHER
OTHER
Interventions
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Web-based Survey
Participants will be directed to online forms to report general information (ex. age, sex, test results, family history), suspected medication-related acute attacks, and "uneventful use of possibly risky medication". If a patient has multiple medication-related acute attacks, the patient/caregiver will be able to submit multiple report forms that will be linked. In addition to the report forms, patients will be asked to review a list of "Medications of Interest" and report current or past use.
Eligibility Criteria
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Inclusion Criteria
* Enrolled in the RDCRN PC Contact Registry
* Self-reported patient or caregiver of patient with acute porphyria
There are no restrictions on age, sex or ethnicity. However, the following criteria will be applied to those reports that are considered evaluable (analyzed and scored):
1. Medication name must be specified
2. The data elements required in the scoring system must be complete
Exclusion Criteria
ALL
No
Sponsors
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University of Texas
OTHER
Wake Forest University Health Sciences
OTHER
University of Miami
OTHER
University of Washington
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
University of Alabama at Birmingham
OTHER
University of California, San Francisco
OTHER
University of Utah
OTHER
National Institutes of Health (NIH)
NIH
University of South Florida
OTHER
Responsible Party
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Principal Investigators
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D. Montgomery Bissell, MD
Role: STUDY_CHAIR
University of California, San Francisco
Bruce Wang, MD
Role: STUDY_CHAIR
University of California, San Francisco
Locations
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University of South Florida Data Management Coordinating Center
Tampa, Florida, United States
Countries
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References
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Anderson KE, Bloomer JR, Bonkovsky HL, Kushner JP, Pierach CA, Pimstone NR, Desnick RJ. Recommendations for the diagnosis and treatment of the acute porphyrias. Ann Intern Med. 2005 Mar 15;142(6):439-50. doi: 10.7326/0003-4819-142-6-200503150-00010.
de Matteis F. Disturbances of liver porphyrin metabolism caused by drugs. Pharmacol Rev. 1967 Dec;19(4):523-57. No abstract available.
Seth AK, Badminton MN, Mirza D, Russell S, Elias E. Liver transplantation for porphyria: who, when, and how? Liver Transpl. 2007 Sep;13(9):1219-27. doi: 10.1002/lt.21261.
Slavin SA, Christoforides C. Thiopental administration in acute intermittent porphyria without adverse effect. Anesthesiology. 1976 Jan;44(1):77-9. doi: 10.1097/00000542-197601000-00021. No abstract available.
Thunell S, Pomp E, Brun A. Guide to drug porphyrogenicity prediction and drug prescription in the acute porphyrias. Br J Clin Pharmacol. 2007 Nov;64(5):668-79. doi: 10.1111/j.0306-5251.2007.02955.x. Epub 2007 Jun 19.
Other Identifiers
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PC 7208
Identifier Type: -
Identifier Source: org_study_id
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