Phase II/III of Recombinant Human Albumin Injection

NCT06411743 | Completed Phase 2

• 1 other identifier: ART-2021-005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Ascites

Keywords

Hepatic Ascites

Outcome Measures

Primary Outcomes (1)

• Change from baseline in ALB

  The change in 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 (5)

• Proportion of subjects with serum ALB level reaching 35 g/L at the end of administration

  Day 7/14

• Time taken to attain serum ALB of 35 g/L

  Day1- Day7/14

• Change from baseline in body weight of subjects at the end of administration

  Day 7/14

• Change from baseline in abdominal circumference of subjects at the end of administration

  Day 7/14

• Change from baseline in ascites depth of participantsubjects at the end of administration

  Day 7/14

Study Arms (4)

Treatment group1

EXPERIMENTAL

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

Biological: Recombinant Human Albumin Injection

Treatment group2

EXPERIMENTAL

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

Biological: Recombinant Human Albumin Injection

Control group1

ACTIVE COMPARATOR

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

Biological: Human Albumin

Control group2

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 group1; Treatment group2

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 group1; Control group2

Eligibility Criteria

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

You may qualify if:

• 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).

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 \> 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University (Leading Site)

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 Officials

• Junqi Junqi

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: May 13, 2024
• Study Start: September 7, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: May 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)