hepatic ascites
Conditions
Interventions
Group 2:Human Albumin
Sponsors
Chinese Academy of Medical Sciences Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Agree to follow the experimental treatment plan and visit plan, voluntarily join the group, and sign the informed consent in writing; 2. The age on the day of signing the informed consent form is >= 18 years and < 65 years old, regardless of gender; body mass index (BMI) is within the range of 18.5~28.0 kg/m2 (including the boundary value); 3. Patients with clinically diagnosed ascites with decompensated cirrhosis, and ascites grade 1-2 confirmed by abdominal ultrasonography during the screening period, and serum albumin (ALB) < 30 g/L; 4. Males and females of childbearing age (Women of childbearing age include premenopausal women and women within 2 years after menopause) who are fertile are willing to take high-efficiency contraceptive measures (Take condoms, contraceptive sponges, contraceptive gels, contraceptive films, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.) from the time of signing the informed consent to 3 months after the last dose of the investigational drug; females of childbearing potential must have a negative pregnancy test result within <= 7 days prior to the first dose of the investigational product.
Exclusion criteria
Exclusion criteria: 1. Malignant ascites or diagnosed as refractory ascites according to the diagnostic criteria for refractory ascites recommended by the American Association for the Study of Liver Diseases (AASLD) in 2012; 2. Those who have known allergic history/allergic reaction to yeast or yeast-derived products, or those who are allergic to any component in the research preparation; allergic constitution (multiple drugs or food allergy), or history of allergy to biological products, history of severe systemic allergic reaction caused by other reasons, and the investigator judges that it is not suitable to use the experimental drug; those who are positive for anti-yeast antibodies at screening; 3. Child-Pugh classification (see Appendix II for details) in the screening period is C; 4. The patient has the following laboratory abnormalities: (1) Bone marrow function: absolute neutrophil count (ANC) upper limit of normal (ULN); urine protein test results are abnormal and clinically significant; 5. There is active cardiovascular disease or medical history at the time of screening, or other investigators judge that it is not suitable to receive human serum albumin therapy, including but not limited to, hypertension (systolic blood pressure>140 mmHg or diastolic blood pressure>90 mmHg, unless the investigator judges that the drug is well controlled and the condition is stable), severe anemia, acute heart disease, severe cardiopulmonary or structural heart disease, severe arrhythmia, (Neuvolemic or hypervolemic) decompensated heart failure, unstable angina, myocardial infarction within the past 6 months before screening, tachycardia/bradycardia requiring drug therapy, third-degree atrioventricular block, etc.; 6. There is active metabolic system disease or medical history at the time of screening, or renal injury that is judged by other investigators to be unsuitable for serum albumin therapy, specifically, including but not limited to renal/postrenal anuria, hepatorenal syndrome (HRS), chronic kidney disease, hepatitis B-related nephropathy, etc.; 7. Those with the following active concurrent diseases at the time of screening, including but not limited to, severe esophagogastric varices, pulmonary edema, bleeding tendency or active bleeding disease, persistent or active infection (including active spontaneous bacterial peritonitis [SBP]), grade III or IV hepatic encephalopathy according to West-Haven classification, portal vein tumor thrombus/thrombus, circulatory dysfunction after paracentesis, obstructive biliary disease, thyroid dysfunction (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0 grade 3 and above) determined by ultrasound or other imaging tests; 8. Active malignancy (including hepatocellular carcinoma [HCC]) at the time of screening, or a history of malignancy within the past 5 years (cancer in situ of cervical cancer or breast cancer receiving curative treatment, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ and other very low-risk malignancies are excluded); 9. Those who have received corticosteroids or human plasma preparations (including human serum albumin preparations) within 30 days before the first administration of the investigational drug; those who have a history of organ transplantation; du
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK evaluation index;PD evaluation index;Immunogenicity evaluation; | — |
Countries
China
Contacts
Public ContactChen Rui
Peking Union Medical College Hospital
Outcome results
None listed