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

Hepatic Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06355479
• Other study ID #: HY1001-2022-P3
• Status: Completed
• Phase: Phase 3
• Start date: April 10, 2023
• Est. completion date: December 12, 2023

Study information

• Verified date: April 2024
• Source: Healthgen Biotechnology Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: December 12, 2023
• Est. primary completion date: November 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Hepatic Cirrhosis
• Hypoalbuminemia
• Liver Cirrhosis

Intervention

Drug:
• OsrHSA
Recombinant Human Serum Albumin from Oryza Sativa
• Plasbumin®-20
Albumin (Human) 20%, USP

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Healthgen Biotechnology Corp.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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