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 range18 Years – 65 Years
SexALL
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.
Exclusion criteria
✕. Patients with malignant ascites;
✕. 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);