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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT03223194
Eligibility Criteria:
Key Inclusion Criteria:
* Subject has a diagnosis of Crigler-Najjar syndrome resulting from a confirmed mutation in the UGT1A1 gene as assessed by a Sponsor-approved testing facility.
* Subject is aged ≥1 year.
* Subject is prescribed daily phototherapy for a minimum of 6 hours within a 24-hour period (daily illumination time).
Key Exclusion Criteria:
* Subject is currently participating in an interventional study or has received gene or cell therapy.
* Subject has received a whole liver, partial liver, or hepatocyte transplant; or subject has a liver transplant scheduled within the treatment period of this study.
* Subject has significant cholestatic disease at screening.
* Subject is receiving phenobarbital or other known inducer of UGT1A1 within 30 days of screening.
* Subject tests positive for AAV8 neutralizing antibodies with titers above protocol specified threshold.
* Other than as required per protocol, subject has received immune-modulating agents within 3 months before dosing (use of inhaled corticosteroids to manage chronic respiratory conditions is allowed); use of other concomitant medications to manage chronic conditions must have been stable for at least 4 weeks before dosing.
* Subject has any clinically significant laboratory values, in the opinion of the investigator.
* Subject has clinically significant underlying liver disease (other than CN) at screening.
* Subject has a history of, or currently has, a clinically important condition other than CN, in the opinion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT03223194
Study Brief:
Protocol Section:
NCT03223194