Phase II/III of Recombinant Human Albumin Injection (NCT06411743) | Clinical Trial Compass
CompletedPhase 2
Phase II/III of Recombinant Human Albumin Injection
China90 participantsStarted 2021-09-07
Plain-language summary
This study was a Phase II/III multicenter, blinded, and positiveactive-controlled clinical study with seamless adaptive design to evaluate the dose-response relationship, safety, and immunogenicity of recombinant human albumin(rHA) injection for the treatment of hypoalbuminemia in cirrhotic patients with ascites, and to provide a reference for the design of the Phase III clinical study.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Male or female subjects aged 18-65 years (inclusive).
* Subjects with body weight ≥ 55.0 kg.
* 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 (based on test values on Day -14 to Day -3).
* 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 \> 9.5 × 10\^9/L, or neutrophil percentage \> 80% (including 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 Ă— the upper limit of normal (ULN), or Cr increased by \> 50% duringat screening period; or presence of urine protein 2+ or more.
* Subjects with other severe underlying conditions that, in the op…