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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT07183293
Eligibility Criteria:
Inclusion Criteria:
1. Clinical diagnosis of compensated HBV-related liver cirrhosis (Child-Pugh class A or B);
2. The subject is able to understand and comply with the content, requirements, and restrictions of the protocol, is willing and able to complete the study per protocol requirements, fully understands the potential adverse reactions, and voluntarily provides written informed consent prior to study initiation;
3. Aged 18 to 60 years (inclusive), any gender;
4. Female subjects of childbearing potential must have a negative pregnancy test at screening;
5. Subjects (including their partners) must voluntarily use effective non-drug contraception from prior to dosing until six months after discontinuation of the study drug and have no plan to donate sperm or ova; or subjects (including their partners) are of non-childbearing potential (surgically sterilized or postmenopausal).
Exclusion Criteria:
1. Decompensated liver cirrhosis, hepatic failure, or hepatocellular carcinoma; presence of other liver diseases such as fatty liver disease, alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, or Wilson's disease;
2. History of clinically significant diseases of the cardiovascular, hematological and lymphatic, respiratory, urinary, endocrine, immune, psychiatric, or nervous systems (e.g., epilepsy), ophthalmic diseases, or thyroid-related disorders;
3. Pregnancy, lactation, or intention to become pregnant during the study period;
4. Known or suspected allergy to the investigational product(s) or any of its excipients;
5. Participation in any other interventional clinical trial within 3 months prior to screening or planning to participate in another clinical trial during the study;
6. Any other condition considered by the investigator to be inappropriate for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07183293
Study Brief:
Protocol Section:
NCT07183293