hepatic ascites
Conditions
Interventions
Group 1:Recombinant human serum albumin injection 20g/day, continuous administration for 7 days
Group 2: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.Agree to follow the experimental treatment plan and visit schedule, voluntarily join the group, and sign a written informed consent form; 2.On the day of signing the informed consent form, the age is between 18 and 70 years old, and there is no gender limit; Body mass index (BMI) within the range of 17.0-29.0 kg/m² (including boundary values); 3.Patients diagnosed clinically with decompensated liver cirrhosis ascites, and confirmed by abdominal ultrasound examination during screening to have ascites grading of 1-2, while meeting the requirement of serum albumin (ALB)<30 g/L; 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; Women of childbearing age must have a negative pregnancy test result within = 7 days before the first trial drug administration.
Exclusion criteria
Exclusion criteria: 1.Individuals with a known history of allergies/allergic reactions to yeast or yeast derived products, or those who are allergic to any component of the study formulation; Individuals with an allergic constitution (multiple drug or food allergies) or a history of allergies to biological products, as well as a history of severe systemic allergic reactions caused by other reasons and deemed unsuitable for treatment with the investigational drug by the researcher; 2.During the screening process, there were serious digestive system diseases and complications that the researchers deemed unsuitable for participation in this study, including but not limited to malignant ascites, diagnosis of grade III or IV hepatic encephalopathy according to the West Haven grading criteria, portal vein cancer thrombus/thrombus, circulatory dysfunction after abdominal puncture, biliary obstructive disease determined by ultrasound or other imaging examinations, gastrointestinal bleeding that stopped bleeding after treatment for less than 10 days or endoscopic ligation could not effectively stop bleeding, or those assessed by the researchers as having a high risk of bleeding during the trial period (such as severe esophagogastric varices with positive red sign on gastroscopy within 3 months before screening); 3.When screening, there is a history of active cardiovascular disease or other conditions that researchers determine are not suitable for receiving human serum albumin treatment, including but not limited to hypertension (systolic blood pressure>140 mmHg or diastolic blood pressure>90 mmHg, except for those determined by researchers to have good medication control and stable condition), severe anemia, acute heart disease, severe cardiovascular or structural heart disease, severe arrhythmia, decompensated heart failure (normal blood volume or high blood volume), unstable angina pectoris, myocardial infarction in the past 6 months before screening, tachycardia/bradycardia requiring medication treatment, third degree atrioventricular block, etc; 4.Active metabolic system disease or medical history (except for diabetes patients with stable blood glucose control as judged by the investigator), or combined with renal function injury, which is not suitable for serum albumin treatment as judged by the investigator; 5.When screening, there were serious underlying diseases that the researchers deemed unsuitable for participation in this study, including but not limited to active malignant tumors (including hepatocellular carcinoma [HCC]), pulmonary edema, bleeding tendency or active bleeding disease, uncontrolled infections (including active spontaneous bacterial peritonitis [SBP1]), thyroid dysfunction (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events INCICTCAEI 5.0 grade 3 or above), pleural effusion that the researchers determined may require treatment or have disease changes throughout the entire trial process, etc; 6.The patient has the following laboratory test abnormalities: (1) Bone marrow function: Absolute neutrophil count (ANC)5 × ULN (upper limit of normal); Aspartate aminotransferase (AST)>5 × ULN; Serum bilirubin (TBIL)>4 x upper limit of normal (ULN) or deemed unsuitable for participation in the trial by the researcher; (3) Renal function: serum creatinine>3 times the upper limit of nor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in serum albumin concentration confirmed by albumin examination immediately after the completion of secondary intravenous administration compared to baseline (based on the results of central laboratory tests); | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement rate of ascites at the completion of the last intravenous administration is defined as the regression of ascites in patients with grade 1 ascites after treatment at baseline, and the degradation of ascites or a decrease in ascites depth of = 25% compared to baseline in patients with grade 2 ascites after treatment;The change in serum albumin concentration confirmed by local laboratory albumin test immediately after the last intravenous administration compared to baseline;Changes in ascites depth from baseline upon completion of the last intravenous administration;The proportion of subjects whose serum albumin concentration confirmed by albumin examination at the completion of the last intravenous administration is = 35 g/L;The time for serum albumin concentration to reach = 35 g/L;Changes in abdominal circumference compared to baseline at the completion of the last intravenous administration;Changes in body weight compared to baseline at the completion of the last intravenous administration;The change in serum albumin concentration confirmed by albumin examination immediately after the completion of the last intravenous administration during the second treatment period compared to the baseline before the second treatment;The improvement rate of ascites at the completion of the last intravenous administration during the re treatment period is defined as the regression of ascites after treatment in patients with grade 1 ascites at baseline during the re treatment period, and the degradation of ascites or a decrease in ascites depth of = 25% after treatment in patients with grade 2 ascites at baseline during the re treatment period;Changes in ascites depth at the completion of the last intravenous administration during the second treatment period compared to baseline before the second treatment;Proportion of subjects with serum albumin concentration = 35 g/L confirmed by albumin examination during the re treatment period;The time when the serum albumin | — |
Countries
China
Contacts
Public ContactJia Jidong
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed