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:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT05786859
Eligibility Criteria:
1. Inclusion Criteria:
* The confirmed HBsAg positive patients with chronic hepatitis B are defined as HBsAg positive for at least 6 months or evidence of chronic HBV infection;
* Acute onset, progressive deepening of jaundice, serum total bilirubin (TB) ≥ 85umol/L and severe coagulation dysfunction, international standardized ratio (INR) ≥ 1.5 or plasma prothrombin activity (PTA)\<40%
* The score of the psychological test scale of hepatic encephalopathy is less than - 4 points or mild to moderate (degree I or II) manifestations of hepatic encephalopathy, including the decline of computational ability, timing and orientation, personality change, lethargy, and positive flapping wing tremor.
* Be able and willing to provide informed consent and comply with the test requirements.
2. Exclusion Criteria:
* There are definite infections or hepatorenal syndromes during screening;
* Upper gastrointestinal bleeding occurred within 1 week before screening;
* Have used sedative drugs such as "benzodiazepines" or other psychotropic drugs within one week before screening;
* Those with severe primary heart, lung, kidney and other important organ dysfunction affecting life expectancy;
* HIV infection;
* Uncontrolled malignant tumor, nerve and mental abnormality;
* Patients who are allergic to the study drugs and excipients;
* Pregnant or lactating women;
* In the late stage of liver failure, MELD score\>35;
* Other circumstances in which the researcher believes that the patient should not participate in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05786859
Study Brief:
Protocol Section:
NCT05786859