Clinical trial NCT06355479: A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoalbuminemia
Hepatic Cirrhosis
Lead sponsor: Healthgen Biotechnology Corp.
Sponsor class: INDUSTRY
First posted: 2024-04-09
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the efficacy of OsrHSA on elevating the serum albumin level.
timeFrame: Day 1 to Day 14
Secondary outcomes:
measure: To estimate the time to reach 35 g/L or more in serum albumin
timeFrame: Day 1 to Day 14
measure: To estimate the change from baseline in serum albumin
timeFrame: Day 1 to Day 14
measure: To estimate the change from baseline in colloid osmotic pressure
timeFrame: Day 1 to Day 14
measure: To estimate the change from baseline in body weight
timeFrame: Day 1 to Day 14
measure: To estimate the change from baseline in abdominal circumference, and ascites severity
timeFrame: Day 1 to Day 14
measure: To estimate the change from baseline in ascites severity
timeFrame: Day 1 to Day 14
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
state: Guangdong
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Zunyi
country: China
facility: Affiliated Hospital Of Zunyi Medical University
state: Guizhou
city: Harbin
country: China
facility: The Fourth Affiliated Hospital, Harbin Medical University
state: Heilongjiang
city: Luoyang
country: China
facility: Luoyang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The Sixth People's Hospital of Zhengzhou
state: Henan
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Shiyan
country: China
facility: TaiHe Hospital
state: Hubei
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Wuhan Jinyintan Hospital
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Yueyang
country: China
facility: Yueyang Central Hospital
state: Hunan
city: Zhenjiang
country: China
facility: The Third People's Hospital of Zhenjiang
state: Jiangsu
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Yichun
country: China
facility: Yichun People's Hospital
state: Jiangxi
city: Chang chun
country: China
facility: Hepatobiliary Hospital Of Jilin
state: Jilin
city: Chang chun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The Sixth People's Hospital of Shenyang
state: Liaoning
city: Xining
country: China
facility: The People's Hospital of Qinghai
state: Qinghai
city: Jinan
country: China
facility: Shandong Public Health Clinical Center
state: Shandong
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Rui'an
country: China
facility: Ruian People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First School of Medicine, School of Information and Engineering, The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: