Decompensated Hepatitis B Cirrhosis
Conditions
Interventions
Intensive treatment group (Part one):Patients with serum albumin =34g/L. The patients albumin concentration will be re evaluated at the 8-week, 16 week, and 24 week visits. Albumin injection will be g
Health control group (Part two):None
Group of decompensated hepatitis B cirrhosis patients (Part two):None
Group of chronic hepatitis B patients (Part two):None
Group of Hepatitis B-related cirrhosis complicated by hepatocellular carcinoma Patients (Part two):None
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients of Decompensated Hepatitis B Cirrhosis: 1. Age of at least 18 years; 2. Weight of at least 45.0 kg; 3. Diagnosed with decompensated hepatitis B cirrhosis according to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)" issued by the Chinese Society of Hepatology, Chinese Medical Association; 4. Hemoglobin level of at least 70 g/L and platelet count of at least 30×10^9/L at screening; 5. Lowest albumin level below 30 g/L during screening; 6. Child-Pugh score of 12 or less at screening; 7. Willing to participate and sign the informed consent form. Health control group: Matched with the decompensated cohort of hepatitis B cirrhosis in age and sex.
Exclusion criteria
Exclusion criteria: Patients of Decompensated Hepatitis B Cirrhosis: 1. Chronic liver disease caused by non-HBV factors (e.g., HCV infection, alcoholic liver disease, severe fatty liver, drug-induced liver injury, autoimmune liver disease, genetic metabolic liver disease, etc.); 2. History of allergy to human albumin or other blood products; 3. Grade 3 or higher hepatic encephalopathy; 4. History of nephrotic syndrome, or serum creatinine (Cr) > 2×ULN, or Cr increase > 50 µmol/L during the screening period; proteinuria 2+ or higher; 5. Chronic liver failure or acute-on-chronic liver failure (PTA10×ULN); 6. Concurrent severe diseases, including but not limited to malignant tumors, portal vein thrombosis (greater than 50% of the portal vein diameter), ascites due to non-cirrhotic portal hypertension, ischemic heart disease, stroke, chronic obstructive pulmonary disease, Grade III-IV heart failure, left ventricular ejection fraction (LVEF) < 50%, gastrointestinal bleeding within 14 days after treatment or ineffective hemostasis after endoscopic treatment; 7. Organ transplant recipients; 8. Poor patient compliance, unable to meet visit requirements; 9. Patients deemed unsuitable for participation in this study by the investigator. Health control group: Merge other chronic liver diseases, kidney diseases, and other major illnesses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Albumin isoforms and their relative proportions (Part two);Ratio of recompensation patients at 72 weeks (Part one);Ratio of recompensation patients at 72 weeks (Part three);Concentration of unmodified albumin (Part two);Albumin functional parameters (Part two); | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function (Part one);Renal function (Part one);Child-Pugh score (Part one);MELD score (Part one);Complications related to decompensated liver cirrhosis (Part one);Liver disease related deaths (Part one);Occurrence of interstitial pulmonary edema (Part one);Related factors for decompensated cirrhosis and recompensation (Part three);Inflammatory markers (Part one); | — |
Countries
China
Contacts
Public ContactXie Wen
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed