A Study of Recombinant Human Albumin Injection to Treat Hypoalbuminemia in Cirrhotic Patients With Ascites

NCT ID: NCT06911554

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-16
• Study Completion Date: 2024-09-27

Brief 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.

Detailed Description

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.

Conditions

Hepatic Ascites

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

Recombinant Human Albumin Injection

Intervention Type: BIOLOGICAL

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.

Control group

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

Group Type: ACTIVE_COMPARATOR

Human Albumin

Intervention Type: BIOLOGICAL

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.

Interventions

Recombinant Human Albumin Injection

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.

Intervention Type: BIOLOGICAL

Human Albumin

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 stage C and D liver cancer (according to the Barcelona liver cancer staging criteria), or hepatocellular carcinoma (HCC) stage A/B requiring chemotherapy, intervention, surgery, or a combination of liver cancer Patients with hepatic venous cancer thrombus;
• transplant subjects
• Female subjects of childbearing age who test positive for serological pregnancy, or female subjects of childbearing age and male subjects who refuse to use contraception during the trial period or within 6 months after the last dose;
• Subjects who had participated in other clinical trials and used the investigational drug within 3 months prior to screening.
• The patient has the following laboratory test abnormalities: (1) Platelets (PLT)<30x10 ^ 9/L; Hemoglobin (HGB)<70gL; (2) Alanine aminotransferase (ALT)>5 × ULN (upper limit of normal); Aspartate aminotransferase (AST)>5 × ULN; Serum bilirubin (TBIL)>3 x upper limit of normal (ULN) ; (3) Prothrombin activity was <40%, and prothrombin time (PT) was longer than 5s; (4) Left ventricular ejection fraction (LVEF) <50%.
• Individuals who test positive for human immunodeficiency virus (HIV) antibodies; Treponema pallidum specific antibody positive and treponema pallidum non-specific antibody titer positive (unless no intervention is required during the study period assessed by the investigator);
• Other reasons the investigator considered not suitable to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: collaborator

Tonghua Anrate Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

ART-2021-005

Identifier Type: -

Identifier Source: org_study_id