Phase II/III of Recombinant Human Albumin Injection

Jilin University

Status and phase: Completed; Phase 2

Conditions: Hepatic Ascites

Treatments: Biological: Human Albumin; Biological: Recombinant Human Albumin Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06411743

ART-2021-005

Details and patient eligibility

About

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.

Full description

This study was a Phase II/III multicenter, blinded, and positive-controlled clinical study with seamless adaptive design. The Phase II clinical study was conducted first, followed by the Phase III clinical study.The Phase II clinical study aimed 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 provide a reference for the design of Phase III clinical study. Dosage: For the 10 g/day rHA injection group, the subjects were administered rHA at a dose of 10 g/day once daily for 14 days. For the 20 g/day rHA injection group, the subjects were administered rHA at a dose of 20 g/day once daily for 7 days.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 × 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 opinion of the investigator, affected the participation in this study, including but not limited to malignancies (except for liver cancer patients without portal vein or hepatic vein tumor thrombosis), complicated portal vein thrombosis, non-cirrhotic portal hypertension-related ascites, ischemic heart disease, stroke, chronic obstructive pulmonary disease, and Grade III-IV heart failure, and those with gastrointestinal bleeding who had stopped bleeding for less than 14 days after treatment or failed to stop bleeding after endoscopic variceal ligation.
• Subjects with organ transplant.
• Female subjects of childbearing potential who had a positive serum pregnancy test, or subjects refused to use contraceptive measures during the study.
• Subjects who had participated in other clinical trials and received investigational drugs within 3 months prior to screening.
• Subjects with abnormal laboratory test values:a.Hematology: platelets (PLT) < 30 × 10^9/L, hemoglobin (HGB) < 70 g/L;b.Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 × ULN, serum total bilirubin (TBIL) > 3 × ULN;c.Prothrombin activity < 40%, prothrombin time (PT) prolonged by > 5 seconds;d.Left ventricular ejection fraction (LVEF) < 50%.
• Subjects who were considered inappropriate for participation in the study by the investigator due to other reasons.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 4 patient groups

Treatment group1

Experimental group

Description:

Recombinant Human Albumin Injection,10g/day, once daily for 14 days

Treatment:

Biological: Recombinant Human Albumin Injection

Treatment group2

Experimental group

Description:

Recombinant Human Albumin Injection,20g/day ,once daily for 7 days

Treatment:

Biological: Recombinant Human Albumin Injection

Control group1

Active Comparator group

Description:

Human Albumin,10g/day, once daily for 14 days

Treatment:

Biological: Human Albumin

Control group2

Active Comparator group

Description:

Human Albumin,20g/day, once daily for 7 days

Treatment:

Biological: Human Albumin