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 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT06121427
Eligibility Criteria:
Inclusion Criteria:
* Informed consent of the patient to participate in the study, collect and use data
* Age 18 or older
* Background therapy with bulevirtide for at least 48 weeks
* Negative qualitative PCR test for RNA of viral hepatitis D in peripheral blood before inclusion in the study
* No active liver inflammation
* Liver biopsy performed as part of routine practice (no older than 3 weeks before inclusion in the study) or prescribed biopsy to be performed before bulevirtide interruption
Exclusion Criteria:
* Liver damage not related to viral hepatitis B and D - autoimmune hepatitis, drug or alcohol liver damage, Wilson-Konovalov disease, etc.
* Co-infection with hepatitis C virus
* Patients receiving HBV and HDV therapy not in accordance with standard practice or violations of the Instructions for the medical use of the drug/s
* Moderate/severe renal/liver dysfunction
* Lack of informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06121427
Study Brief:
Protocol Section:
NCT06121427