This study was a Phase III multicenter, blinded, and positive active-controlled clinical study to evaluate the efficacy, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites.
This study was a Phase III multicenter, blinded, and positive active-controlled clinical study to evaluate the efficacy, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites.After the primary efficacy endpoint ALB reaches the equivalence standard (-2 g/L to 2 g/L, test drug - control drug), a non-inferiority judgment will be made for the key secondary efficacy endpoint of the improvement rate of ascites depth (\> -10%, test drug - control drug). Dosage: 20 g/day once daily for 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
416
Recombinant Human Albumin injection, strength: 10 g/vial (20%, 50 mL); storage conditions: 2-8°C, protected from light; manufactured and supplied by Tonghua Anrate Biopharmaceutical Co., Ltd.
Human Albumin (An Pu Lai Shi®), strength: 10 g/vial (protein concentration 20%, 50 mL/vial), storage conditions: 2-8°C, protected from light; manufactured by Shanghai RAAS Blood Products Co., Ltd.
The First Hospital of Jilin University
Changchun, Jilin, China
Change from baseline in ALB
The change in albumin (ALB) was determined by calculating the difference between the value measured after the last dose (immediately after the end of dosing) and the value measured before the first dose (the mean).
Time frame: Day -1/7
Improvement rate of ascites depth
Improvement of ascites depth is defined as: * Ascites subside in patients with baseline grade 1 ascites (none Ascites); * Ascites degrade in patients with baseline grade 2 ascites (ascites grade 1 or no ascites) and ascites depth drop more than 1cm; * Ascites depth of patients with baseline ascites grade 2 decrease by ≥ 25% and the ascites depth drop more than 1cm.
Time frame: Day -1/7
Clinical comprehensive improvement rate
The comprehensive clinical improvement was mainly based on changes in body weight and abdominal circumference. The classification and definition are: * Significant improvement: weight loss ≥ 1 kg, abdominal circumference improvement ≥ 2 cm; * Improvement: weight loss ≥ 1 kg, abdominal circumference reduction less than 2 cm; or weight loss less than 1 kg, abdominal circumference reduction ≥2 cm; * General improvement: abdominal circumference reduction less than 2cm and weight loss less than 1 kg; * Unchanged: no change or abdominal circumference reduction less than 2 cm, no change in body weight or slight increase (increase less than 1 kg); or no change in weight or loss less than 1 kg, no change in abdominal circumference or slight increase (increase less than 2cm); * Deterioration: Weight increase ≥ 1 kg or abdominal circumference increase ≥ 2 cm; * Can not judge as classified above. Improvement rate is defined as the proportion of significant improvement and Improvement subject.
Time frame: Day -1/7
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