12-Week Survival Rate

The percentage of participants who are alive at 12 weeks after enrollment.

12 weeks

Changes from the baseline in COSSH-ACLF II score

The Chinese Severe Hepatitis B Study Group (COSSH), based on a multicenter, open-label large cohort study, has established a novel prognostic scoring system for hepatitis B virus (HBV)-ACLF: COSSH-ACLF II s. The COSSH-ACLF II score is calculated as: 1.649×ln(INR) + 0.457×HE grade + 0.425×ln(neutrophils) + 0.396×ln(TBil) + 0.576×ln(urea) + 0.033×age. Theoretically, the score ranges from \~1.0 to \~15.0, though clinically observed values typically fall between 4.5 and 10.0. A score of less than 7.4 indicates a low-risk group, a score between 7.4 and 8.4 indicates a moderate-risk group, and a score greater than 8.4 indicates a high risk of 28- and 90-day mortality.Higher scores indicate greater severity of liver failure and a worse outcome.

12 weeks

Changes from the baseline in Child-Pugh score

The Child-Pugh Score assesses the prognosis of chronic liver disease based on five indicators: hepatic encephalopathy, ascites, total bilirubin, albumin, and PT/INR. The total score ranges from 5 to 15. Higher scores indicate worse liver function. (Classification: Grade A = 5-6 points; Grade B = 7-9 points; Grade C = 10-15 points.)

12-weeks

Change from Baseline in Clinical Symptom Score

Assessment of clinical symptoms including fatigue, anorexia, nausea, jaundice, and level of consciousness. Each symptom is graded on a scale from 0 (absent) to 3(severe). The individual scores are summed to calculate a total symptom score ranging from 0 to 15. Higher scores indicate more severe symptoms.

12 weeks

4-Week Survival Rate

The percentage of participants who are alive at 4 weeks after enrollment

4 weeks

The rate of participants with adverse outcomes at Week 4 and Week 12

The rate of adverse outcomes, defined as death, treatment abandonment, or liver transplantation.

4-week , 12-week