| Eligibility |
Inclusion Criteria:
1. Agreed to follow the experimental treatment plan and visit plan, voluntarily enrolled
in the group, and signed the informed consent in person;
2. Age =18 years old and =70 years old, regardless of gender, on the date of signing the
informed consent; Body mass index (BMI) was in the range of 18.0 to 29.0 kg/m2
(including boundary values);
3. Patients clinically diagnosed with decompensated cirrhosis with ascites of grade 1 to
grade 2 and serum albumin (ALB) <30 g/L were confirmed by abdominal ultrasound
examination during the screening period.
4. Fertile men and women of childbearing age (women of childbearing age include
premenopausal women and women within 2 years after menopause) are willing to sign the
informed consent from the time after the last administration of the investigational
drug 3 Take effective contraceptive measures (condom, contraceptive sponge,
contraceptive gel, contraceptive film, intrauterine device, oral or injectable
contraceptive, subcutaneous implant, etc.) within a month; Pregnancy test results must
be negative for women of childbearing age within 7 days or less before the initial
trial drug administration.
Exclusion Criteria:
1. People who have a known history of allergy/allergic reaction to yeast or yeast-derived
products, or to any component of the study preparation; Allergic constitution
(multiple drug or food allergy), or have a history of biological product allergy,
other causes Had a history of severe systemic anaphylaxis and was judged by the
investigator to be unsuitable for treatment with the experimental drug;
2. At the time of screening, there were severe digestive diseases and complications that
were deemed unsuitable for participation in this study by the investigators, including
but not limited to malignant ascites and a diagnosis of Grade III or IV liver
according to the West-Haven grading criteria Patients with encephalopathy, portal vein
cancer thrombus/thrombus, circulatory dysfunction after abdominal puncture,
obstructive biliary tract disease identified by ultrasound or other imaging,
gastrointestinal bleeding who stopped bleeding less than 10 days after treatment or
did not effectively stop bleeding after endoscopic ligation, or who were at greater
risk of bleeding during the trial as assessed by the investigator (e.g., before
screening) Gastroscopy within 3 months indicated severe esophageal and fundus varices
with positive red sign);
3. At the time of screening, there was a history of active cardiovascular disease or
other conditions that the investigator judged unsuitable for human albumin therapy,
including, but not limited to, hypertension (systolic blood pressure >140 mmHg or
diastolic blood pressure >90 mmHg, The investigators judged that patients were well
controlled and stable), severe anemia, acute heart disease, severe cardiopulmonary or
structural heart disease, severe arrhythmia, decompensated heart failure (normal or
high blood volume), unstable angina, and nearly 6 Myocardial infarction, medicated
tachycardia/bradycardia, third-degree atrioventricular block occurred within a month;
4. Patients with active metabolic system diseases or medical history (except diabetic
patients with good blood glucose control) at the time of screening, or patients with
combined renal function injury who are not suitable for serum albumin treatment
according to the investigators;
5. If there are serious underlying diseases during screening, the researchers think it is
not suitable to participate in this study. These include, but are not limited to,
active malignancies (including hepatocellular carcinoma [HCC]), pulmonary edema,
bleeding prone or active bleeding diseases, uncontrolled infections (including active
spontaneous bacterial peritonitis [SBP]), thyroid dysfunction (according to the
National Cancer Institute Standard for Common Terminology for Adverse Events [NCI
CTCAE] version 5.0 3 Grade and above), etc.;
6. The patient has the following abnormalities in laboratory examination:
(1). Liver function: alanine aminotransferase (ALT) > 5×ULN (upper limit of normal value);
Aspartate aminotransferase (AST) >5×ULN; Serum bilirubin (TBIL) >4× the upper limit of
normal (ULN) or was deemed unsuitable for trial participation by the investigator; (2)
Renal function: serum creatinine >3× upper limit of normal (ULN), urine protein positive
and deemed unfit for study; (3) Bone marrow function: absolute value of neutrophil (ANC)
<1.0×10^9/L; Platelet (PLT) <20×10^9/L; Hemoglobin (HGB) <70 g/L; (4) Coagulation function:
prothrombin time (PT) extended >5s; 7. Persons who have been treated with human plasma
preparations (including human blood albumin preparations) within 7 days prior to the
initial administration of the experimental drug; People with a history of organ
transplantation; Those who need or plan to undergo interventional invasive testing or
therapy during the study; 8. Those who have participated in or are participating in
clinical trials of other new drugs or medical devices and have used investigational
drugs/investigational treatments within 30 days prior to screening; 9. Those who test
positive for antibodies to the human immunodeficiency virus (HIV); 10. Pregnant or
lactating women; 11. Other reasons why the researcher considered it inappropriate to
participate in the study.
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