Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects (NCT05249374) | Clinical Trial Compass
CompletedPhase 1
Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects
China36 participantsStarted 2021-10-14
Plain-language summary
This trial adopts a randomized, double-blind, positive drug-controlled, dose-escalated phase Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary effectiveness of recombinant human serum albumin in patients with liver cirrhosis and ascites
subjects (both male and female) were screened and enrolled to the three dose levels of 10g, 20 g,and 30 g according to the principle of dose escalation, and 8 out of 12 subjects in each dose group One patient received the test drug, and 4 received a positive drug.
Who can participate
Age range
18 Years – 65 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 plan, voluntarily enroll in the group, and sign the informed consent in person;
. Age ≥18 years old and \<65 years old on the day of signing the informed consent, no gender limitation; Body mass index (BMI) ranged from 18.0 kg/m2 to 29.0 kg/m2 (including boundary values);
. Patients clinically diagnosed as decompensated cirrhotic ascites with ascites grade 1-2 and serum albumin (ALB) \<30 g/L confirmed by abdominal ultrasonography during screening period;
. Men and women of child-bearing age with fertility (childbearing age women including premenopausal women and 2 years after menopause women) from willing to sign a consent form began to experiment with drugs within 3 months after the last delivery effective precautions (take a condom, contraceptive sponge, contraceptive gel, diaphragm, intrauterine device, oral or injectable contraceptives, subcutaneous preparetions Agent, etc.); Women of reproductive age must have a negative pregnancy test no later than 7 days before the first investigational drug is administered.
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.
. People who have a known history of allergy/allergic reaction to yeast or yeast-derived products or are allergic to any component of the study product; Patients with an allergic constitution (multiple drug or food allergy), a history of allergic to biological products, or a history of severe systemic allergic reaction caused by other reasons, and the investigator judges that they are not suitable for treatment with experimental drugs;
. The patient has the following abnormal laboratory tests:
. Active cardiovascular disease or history at the time of screening, or other conditions that the investigator determined were not suitable for human serum albumin therapy, including but not limited to hypertension (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg), Researchers determine drug control is good and stable condition except), severe anemia, heart disease, acute severe lung or structural heart disease, severe arrhythmia, normal blood volume (or high blood volume) of decompensated heart failure, unstable angina, nearly six months prior to screening the myocardial infarction, require drug treatment of tachycardia/slow, three degree atrioventricular block, etc.;
. At the time of screening, there was a history of active metabolic system disease or other renal injury that the investigator determined was unsuitable for serum albumin treatment, including but not limited to renal/postrenal anuria, hepatorenal syndrome (HRS), chronic kidney disease, hepatitis B related nephropathy, etc.;
. Patients with the following active concurrent diseases during screening, including but not limited to, Pulmonary edema, bleeding tendency, or active bleeding disease, sustained or active infection (including active spontaneous bacterial peritonitis (SBP)), according to West - Haven classification standard diagnosis of hepatic encephalopathy grade III or IV level, portal venous tumor emboli/blood clots, circulation dysfunction after abdominal puncture, ultrasound and other imaging examination of biliary obstructive disease Disease, thyroid dysfunction (grade 3 and above according to NCI CTCAE version 5.0);
. Patients with previous history of upper gastrointestinal bleeding within 1 month or gastrointestinal bleeding within 3 months (≥2 times) or high risk of bleeding during the study as assessed by the investigator;
. Patients with active malignancies (including hepatocellular carcinoma \[HCC\]) at the time of screening, or with a history of malignant tumors within 5 years (except cancer in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ and other very low-risk malignancies of cervical or breast cancer undergoing curative treatment);