Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites (NCT06553456) | Clinical Trial Compass
CompletedPhase 2/3
Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites
China390 participantsStarted 2024-08-19
Plain-language summary
This trial adopts random, double-blind, positive control, parallel group design to evaluate the effectiveness and safety of recombinant human serum albumin versus human serum albumin in hepatic cirrhosis patients with ascites.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Agree to follow the experimental treatment plan and visit schedule, voluntarily join the group, and sign a written informed consent form;
. 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);
. 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;
. 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
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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);
. 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;
. 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;
. 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;
. The patient has the following laboratory test abnormalities: (1) Bone marrow function: Absolute neutrophil count (ANC)\<1.0x10 \^ 9/L; Platelets (PLT)\<20x10 \^ 9/L; Hemoglobin (HGB)\<70gL; (2) Liver function: Alanine aminotransferase (ALT)\>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 normal (ULN), positive urine protein, and the researcher's judgment that it is not suitable to participate in the trial; (4) Coagulation function: prothrombin time (PT) prolonged\>5s；
. Individuals who have received human plasma preparations (including human albumin preparations) within 7 days prior to the first administration of the investigational drug; Individuals with a history of organ transplantation; Those who need to undergo or plan invasive invasive examinations or treatments during the research period;
. Participated in or was participating in clinical trials of other new drugs or medical devices within 30 days prior to screening, and used the investigational drug/treatment provider;