The goal of this clinical trial is to evaluate the efficacy of OsrHSA works to treat hypoalbuminemia in hepatic cirrhosis patients. It will also learn about the safety and immunogenicity of OsrHSA. The main question it aims to answer is whether OsrHSA is effective in elevating the serum albumin level of cirrhotic patients with hypoalbuminemia. Researchers will compare OsrHSA to the positive comparator, plasma-derived HSA (pHSA) to see if OsrHSA presents as non-inferior to pHSA in the indication of hypoalbuminemia in hepatic cirrhosis patients. Participants will be randomized in a 1:1 ratio to receive OsrHSA or HpHSA (20g IV qd) for up to 14 days, following an EOT visit. Follow-up visits will be taken on EOT+7d, EOT+14d, and EOT+30d, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
328
Recombinant Human Serum Albumin from Oryza Sativa
Albumin (Human) 20%, USP
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
To evaluate the efficacy of OsrHSA on elevating the serum albumin level.
Percentage of participants whose albumin level reaches 35 g/L or above at any time up to 14 days of the study intervention.
Time frame: Day 1 to Day 14
To estimate the time to reach 35 g/L or more in serum albumin
Time to reach serum albumin 35 g/L or more by the end of the treatment (EOT)
Time frame: Day 1 to Day 14
To estimate the change from baseline in serum albumin
To estimate the change from baseline to the end of treatment (EOT) in serum albumin
Time frame: Day 1 to Day 14
To estimate the change from baseline in colloid osmotic pressure
The change from baseline to the end of treatment (EOT) will be measured in Colloid osmotic pressure
Time frame: Day 1 to Day 14
To estimate the change from baseline in body weight
The change in body weight will be measured from baseline to the end of treatment (EOT)
Time frame: Day 1 to Day 14
To estimate the change from baseline in abdominal circumference, and ascites severity
The change in abdominal circumferences will be measured from baseline to the end of treatment (EOT)
Time frame: Day 1 to Day 14
To estimate the change from baseline in ascites severity
The change in ascites severity will be measured from baseline to the end of treatment (EOT)
Time frame: Day 1 to Day 14
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The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Nanfang Hospital
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
...and 27 more locations