A Study of Recombinant Human Albumin Injection to Treat Hypoalbuminemia in Cirrhotic Patients Wit… (NCT06911554) | Clinical Trial Compass
CompletedPhase 3
A Study of Recombinant Human Albumin Injection to Treat Hypoalbuminemia in Cirrhotic Patients With Ascites
China416 participantsStarted 2023-06-16
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Male or female subjects aged 18-75 years (inclusive).
* BMI≥18.0 kg/m\^2.
* Subjects who were diagnosed as liver cirrhosis with ascites according to the Guidelines for Diagnosis and Treatment of Liver Cirrhosis with Ascites and Related Complications (2017) issued by the Chinese Society of Hepatology CMA, with ascites graded 1-2 at diagnosis or after treatment, and also met the requirement of ALB \< 30 g/L ;
* Subjects who were able to understand and comply with the study procedures, voluntarily participated this study, and had signed the informed consent form (ICF).
Exclusion Criteria:
* Subjects with a history of allergies to biological products derived from Escherichia coli, yeast, or Chinese hamster ovary (CHO) cells, or blood products such as HSA.
* Subjects with hepatic encephalopathy of West-Haven HE Grade III or higher.
* Subjects with uncontrolled infections, such as body temperature \> 37.5°C, white blood cell count \> 1.0 × 10\^10/L, or severe abdominal infection, upper respiratory tract infection, lower respiratory tract infection, urinary system infection, etc.).
* Subjects with a history of hepatorenal syndrome (HRS), or serum creatinine (Cr) \> 2 × the upper limit of normal (ULN), or Cr increased by \> 50% during screening period; or presence of urine protein 2+ or more.
* Subjects with other severe underlying conditions that, in the opinion of the investigator, affected the participation in this study, including but not limited to malig…