hepatic ascites
Conditions
Interventions
Group 1:Recombinant human serum albumin 10 g/day for 14 consecutive days
Group 2:Recombinant human serum albumin 20 g/day for 7 consecutive days
Group 3:Human serum albumin 10 g/day for 14 consecutive days
Group 4:Human serum albumin 20 g/day, continuously administered for 7 days
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
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. Men with fertility and women of childbearing age (women of childbearing age include premenopausal women and women within two years after menopause) are willing to take effective contraceptive measures (condoms, contraceptive sponges, contraceptive gel, contraceptive membranes, intrauterine devices, oral or injectable contraceptives, subcutaneous implants, etc.) within three months after the last administration of the trial drug from the date of signing the informed consent; Pregnancy test results must be negative for women of childbearing age within 7 days or less before the initial trial drug administration.
Exclusion criteria
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) Bone marrow function: absolute value of neutrophil (ANC) 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; (3) Renal function: serum creatinine >3× upper limit of normal (ULN), urine protein positive and deemed unfit for study; (4) Coagulation function: prothrombin time (PT) extended >5s; 7. Persons who have been treated with human plasma preparations (including human blood albumin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in serum albumin concentration from baseline after the completion of the last administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in ascites depth from baseline after administration;Proportion of subjects with serum albumin concentration = 35 g/L after the last administration;The time when the serum albumin concentration reaches = 35 g/L;Changes in abdominal circumference from baseline after administration;Changes in body weight from baseline after administration; | — |
Countries
China
Contacts
Public ContactJia Jidong
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed