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

NCT06911554 | Completed Phase 3 DMC

• 1 other identifier: ART-2021-005
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Ascites

Keywords

Hepatic Ascites

Outcome Measures

Primary Outcomes (1)

• Change from baseline in ALB

  The change in albumin (ALB) was determined by calculating the difference between the value measured after the last dose (immediately after the end of dosing) and the value measured before the first dose (the mean).

  Day -1/7

Secondary Outcomes (2)

• Improvement rate of ascites depth

  Day -1/7

• Clinical comprehensive improvement rate

  Day -1/7

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Biological: Recombinant Human Albumin Injection

Control group

ACTIVE COMPARATOR

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

Biological: Human Albumin

Interventions

Recombinant Human Albumin Injection 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.

Treatment group

Human Albumin 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.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tonghua Anrate Biopharmaceutical Co., Ltd.: lead
• The First Hospital of Jilin University: collaborator

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Interventions

Serum Albumin, Human

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 4, 2025
• Study Start: June 16, 2023
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)