Porphyrias Clinical Trial
Official title:
Evidence-based Assessment of Medication Sensitivity in Acute Hepatic Porphyria
NCT number | NCT03906214 |
Other study ID # | PC 7208 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 3, 2019 |
Est. completion date | September 13, 2019 |
Verified date | April 2019 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an observational study collecting patient/caregiver reports on suspected medication/drug-induced acute porphyria attacks, as well as safe use of drugs previously labeled "unsafe" or with unknown risk. Participants will be recruited through the RDCRN Contact Registry for the Porphyrias Consortium. The study will be advertised on the Consortium website and through the American Porphyria Foundation's social media network.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 13, 2019 |
Est. primary completion date | September 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Able to read and write in English - 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: - Unable to provide informed consent and complete forms |
Country | Name | City | State |
---|---|---|---|
United States | University of South Florida Data Management Coordinating Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | Icahn School of Medicine at Mount Sinai, National Institutes of Health (NIH), University of Alabama at Birmingham, University of California, San Francisco, University of Miami, University of Texas, University of Utah, University of Washington, Wake Forest University Health Sciences |
United States,
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. Review. Erratum in: Ann Intern Med. 2005 Aug 16;143(4):316. — View Citation
de Matteis F. Disturbances of liver porphyrin metabolism caused by drugs. Pharmacol Rev. 1967 Dec;19(4):523-57. Review. — View Citation
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. Review. — View Citation
Slavin SA, Christoforides C. Thiopental administration in acute intermittent porphyria without adverse effect. Anesthesiology. 1976 Jan;44(1):77-9. — View Citation
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. Epub 2007 Jun 19. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute Attack Form | Designed to capture PBG levels, characteristics of the acute attack, timing of medication administration, and pharmacological information on the medication. | 5 years from study start | |
Primary | Uneventful Use of Possible Risky Medication Form | Designed to capture details of medication in question, ALA/PGB results during use of medication in questions, concomitant medication use, diet history, and alcohol use. | 5 years from study start | |
Primary | Use of Medications of Interest Form | Designed to assess medications used by category and effects of each. | 5 years from study start |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05496933 -
Colombia National Porphyria Registry
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