Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT05496933
Eligibility Criteria:
Inclusion Criteria: - Patients of all age groups with a confirmed diagnosis of acute hepatic porphyria with AT LEAST ONE OF THE FOLLOWING CHARACTERISTICS will be included:
* Acute symptoms consistent with disease and positive urine qualitative porphobilinogen or substantially elevated quantitative porphobilinogen.
* Acute symptoms compatible with the disease and decreased HMBS enzyme activity (less than 50%).
* Mutation in the genetic sequence of the HMBS gene.
* Confirmatory test that identifies the type of porphyria (analysis of total and fractionated porphyrins in urine, feces and plasma).
Patients with concomitant pathologies, as well as pregnant women, will also be included.
Exclusion criteria:
* Patients who refuse to participate in the study will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05496933
Study Brief:
Protocol Section:
NCT05496933