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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT06518005
Eligibility Criteria:
Main Inclusion Criteria:
1. Severe Crigler-Najjar syndrome requiring ≥ 6 hours/ day of phototherapy
2. Molecular confirmation of mutation in the UGT1A1gene by DNA sequencing
3. Detectable serum neutralizing antibodies against AAV8
4. Laboratory parameters value not clinically significant
5. Highly effective method of contraception
6. Affiliated to or a beneficiary of a health care system
Exclusion Criteria:
1. Participation in another interventional trial within 6 months prior to start of clinical trial intervention and during the whole clinical trial
2. Fibrosis score ≥ 3 (METAVIR) or 10 kPa (FibroScan®)
3. Liver transplantation
4. Significant underlying liver disease, chronic hepatitis B, C and/or infected with Human immunodeficiency virus
5. Any other clinically significant illness
6. Uncontrolled hyperlipidemia.
7. History of major thrombotic events, active peripheral vascular disease, proven hypercoagulable conditions,
8. History or presence of thrombotic thrombocytopenic purpura (TTP) or known familial history of TTP
9. Prior or current treatment with Gene therapy, cell based therapy, CRISPR/Cas9 or any other form of gene editing, imlifidase
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06518005
Study Brief:
Protocol Section:
NCT06518005