A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia

A Phase 3 Randomized, Double-blind, Active-controlled Multi-center Study to Evaluate the Efficacy, Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia

The goal of this clinical trial is to evaluate the efficacy of OsrHSA works to treat hypoalbuminemia in hepatic cirrhosis patients. It will also learn about the safety and immunogenicity of OsrHSA. The main question it aims to answer is whether OsrHSA is effective in elevating the serum albumin level of cirrhotic patients with hypoalbuminemia.

Researchers will compare OsrHSA to the positive comparator, plasma-derived HSA (pHSA) to see if OsrHSA presents as non-inferior to pHSA in the indication of hypoalbuminemia in hepatic cirrhosis patients.

Participants will be randomized in a 1:1 ratio to receive OsrHSA or HpHSA (20g IV qd) for up to 14 days, following an EOT visit. Follow-up visits will be taken on EOT+7d, EOT+14d, and EOT+30d, respectively.

Study Overview

• Status: Completed
• Conditions: Hypoalbuminemia; Hepatic Cirrhosis
• Intervention / Treatment: Drug: OsrHSA; Drug: Plasbumin®-20

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Youan Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Beijing Friendship Hospital, Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China
      • Chongqing University Three Gorges Hospital
  • Fujian
    • Fuzhou, Fujian, China
      • The First Affiliated Hospital of Fujian Medical University
    • Fuzhou, Fujian, China
      • Mengchao Hepatobiliary Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Nanfang Hospital
    • Guangzhou, Guangdong, China
      • The Third Affiliated Hospital, Sun Yat-sen University
    • Huizhou, Guangdong, China
      • Huizhou Central People's Hospital
  • Guangxi
    • Guilin, Guangxi, China
      • Affiliated Hospital of Guilin Medical University
    • Liuzhou, Guangxi, China
      • Liuzhou Worker's Hospital
    • Nanning, Guangxi, China
      • The First Affiliated Hospital of Guangxi Medical University
  • Guizhou
    • Zunyi, Guizhou, China
      • Affiliated Hospital of Zunyi Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The Fourth Affiliated Hospital, Harbin Medical University
  • Henan
    • Luoyang, Henan, China
      • Luoyang Central Hospital
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China
      • The Sixth People's Hospital of Zhengzhou
  • Hubei
    • Jingzhou, Hubei, China
      • Jingzhou Central Hospital
    • Shiyan, Hubei, China
      • Taihe Hospital
    • Wuhan, Hubei, China
      • The Central Hospital of Wuhan
    • Wuhan, Hubei, China
      • Wuhan Jinyintan Hospital
    • Yichang, Hubei, China
      • Yichang Central People's Hospital
  • Hunan
    • Yueyang, Hunan, China
      • Yueyang Central Hospital
  • Jiangsu
    • Zhenjiang, Jiangsu, China
      • The Third People's Hospital of Zhenjiang
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • First Affiliated Hospital of Gannan Medical University
    • Nanchang, Jiangxi, China
      • The First Affiliated Hospital of Nanchang University
    • Pingxiang, Jiangxi, China
      • Pingxiang People's Hospital
    • Yichun, Jiangxi, China
      • Yichun People's Hospital
  • Jilin
    • Chang chun, Jilin, China
      • The First Hospital of Jilin University
    • Chang chun, Jilin, China
      • Hepatobiliary Hospital Of Jilin
  • Liaoning
    • Shenyang, Liaoning, China
      • The Sixth People's Hospital of Shenyang
  • Qinghai
    • Xining, Qinghai, China
      • The People's Hospital of Qinghai
  • Shandong
    • Jinan, Shandong, China
      • Shandong Public Health Clinical Center
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital, Sichuan University
  • Yunnan
    • Kunming, Yunnan, China
      • The Second Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Rui'an, Zhejiang, China
      • Ruian People's Hospital
    • Wenzhou, Zhejiang, China
      • The First School of Medicine, School of Information and Engineering, The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

1. Diagnosis of hepatic cirrhosis
2. Adult males or females, aged 18-75 years (both inclusive) at the time of consent
3. Serum albumin level ≤ 30 g/L
4. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol

Main Exclusion Criteria:

1. History of allergy to rice; a history of allergy to any component of the HpHSA product
2. Therapeutic/ Large-volume paracentesis (> 5L each time) during the treatment period
3. Ascites resulted from non-hepatic cirrhosis, Budd-Chiari syndrome
4. Participants with Grade III or Grade IV hepatic encephalopathy using West Heaven Criteria
5. A transjugular intrahepatic peritoneal shunt (TIPS) is performed within 1 month prior to the first dosing
6. Evidence of upper gastrointestinal hemorrhage 6 months prior to the first dosing
7. Participants with stage C and stage D hepatocellular carcinoma according to China Liver Cancer Staging (CNLC) Classification
8. Evidence of extrahepatic neoplastic disorders
9. Transplantation
10. HIV positive
11. Participants with pleural effusion and need therapeutic thoracentesis during the treatment period
12. Uncontrolled infection with body temperature ≥ 38.5 degrees Celsius (101.3 degrees Fahrenheit) or ≤ 35 degrees Celsius (95 degrees Fahrenheit) and white blood cells > 12.0×10^9/L. i.e. severe intraabdominal infections, sepsis, respiratory tract infections, urine tract infections.
13. Other serious underlying diseases, including but not limited to: hepatopulmonary syndrome, heart failure grade III-IV (NYHA scale of heart function), severe structural heart disease, symptomatic ischemic heart disease, severe chest and lung disease, hemodialysis, active biliary obstructive disease, etc.

14. With the following abnormal laboratory test values:

    Hematology: white blood cell count < 2.0×10^9/L, absolute neutrophil count < 1.0×10^9/L, platelets < 30×10^9/L, or hemoglobin < 75 g/L; Chemistry: ALT and/or AST > 5× upper limit of normal (ULN), total bilirubin > 3× ULN; Coagulation: INR>2.0; Renal function: Cr > 2×ULN, urine protein >2+; Echocardiography: LVEF < 50%

15. Pregnant or breastfeeding or plan to get pregnant in 6 months
16. Potentially fertile participants (other than women who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or postmenopause for more than 1 year, and men who have undergone bilateral vasectomy) who do not consent to or are unable to use effective contraception throughout the study and 120 days after the end of the study (or early discontinuation of the study);
17. Enrolled in any clinical trials within 3 months prior to the first dose of study intervention
18. Any other condition that the investigator considers would make the participant unsuitable for the clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OsrHSA; OsrHSA 20g, IV qd, Day1 up to Day 14	Drug: OsrHSA; Recombinant Human Serum Albumin from Oryza Sativa
Active Comparator: pHSA; pHSA 20g, IV qd, Day1 up to Day 14	Drug: Plasbumin®-20; Albumin (Human) 20%, USP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of OsrHSA on elevating the serum albumin level.	Percentage of participants whose albumin level reaches 35 g/L or above at any time up to 14 days of the study intervention.	Day 1 to Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To estimate the time to reach 35 g/L or more in serum albumin	Time to reach serum albumin 35 g/L or more by the end of the treatment (EOT)	Day 1 to Day 14
To estimate the change from baseline in serum albumin	To estimate the change from baseline to the end of treatment (EOT) in serum albumin	Day 1 to Day 14
To estimate the change from baseline in colloid osmotic pressure	The change from baseline to the end of treatment (EOT) will be measured in Colloid osmotic pressure	Day 1 to Day 14
To estimate the change from baseline in body weight	The change in body weight will be measured from baseline to the end of treatment (EOT)	Day 1 to Day 14
To estimate the change from baseline in abdominal circumference, and ascites severity	The change in abdominal circumferences will be measured from baseline to the end of treatment (EOT)	Day 1 to Day 14
To estimate the change from baseline in ascites severity	The change in ascites severity will be measured from baseline to the end of treatment (EOT)	Day 1 to Day 14

Collaborators and Investigators

• Sponsor: Healthgen Biotechnology Corp.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Hematologic Diseases; Liver Diseases; Blood Protein Disorders; Hypoproteinemia; Fibrosis; Liver Cirrhosis; Hypoalbuminemia
• Other Study ID Numbers: HY1001-2022-P3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No