Porphyrias Clinical Trial
Official title:
Evidence-based Assessment of Medication Sensitivity in Acute Hepatic Porphyria
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.
Contact Registrants will be sent an email invitation describing the study. A unique link will
be generated for each registrant and included in the email invitation. After 2 weeks, a
second email invitation will be sent to the registrants who have not yet participated. After
1 month, a third email invitation will be sent to the registrants who have not yet
participated. We may send additional emails periodically (e.g. every 6-12 months) to subjects
enrolled to remind them to complete new surveys if they have taken any other medications of
interest or have experienced any new reactions/attacks.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05496933 -
Colombia National Porphyria Registry
|