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 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT03284658
Eligibility Criteria:
Inclusion Criteria:
* Informed consent will be obtained from the patient or the parents before any study related procedures.
* Patients of both genders older than 2 months
* The patient has a diagnosis of Tyrosinemia type 1 or a high-grade suspicion for Tyrosinemia type 1
High-grade suspicion present, if one or more inclusion criteria are valid:
* Positive family anamnesis for Tyrosinemia type 1
* Hepatomegaly
* Splenomegaly
* Ascites
* Coagulopathy
Exclusion Criteria:
* No Informed consent from the patient or the parents before any study related procedures.
* Patients of both gender younger than 2 months
* No diagnosis of Tyrosinemia type 1 or no valid criteria for profound suspicion of Tyrosinemia type 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Study:
NCT03284658
Study Brief:
Protocol Section:
NCT03284658