A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia
NCT ID: NCT06355479
Last Updated: 2024-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
328 participants
INTERVENTIONAL
2023-04-10
2023-12-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OsrHSA
OsrHSA 20g, IV qd, Day1 up to Day 14
OsrHSA
Recombinant Human Serum Albumin from Oryza Sativa
pHSA
pHSA 20g, IV qd, Day1 up to Day 14
Plasbumin®-20
Albumin (Human) 20%, USP
Interventions
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OsrHSA
Recombinant Human Serum Albumin from Oryza Sativa
Plasbumin®-20
Albumin (Human) 20%, USP
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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Healthgen Biotechnology Corp.
INDUSTRY
Responsible Party
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Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Nanfang Hospital
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Liuzhou Worker's Hospital
Liuzhou, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Affiliated Hospital Of Zunyi Medical University
Zunyi, Guizhou, China
The Fourth Affiliated Hospital, Harbin Medical University
Harbin, Heilongjiang, China
Luoyang Central Hospital
Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
TaiHe Hospital
Shiyan, Hubei, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Wuhan Jinyintan Hospital
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Yueyang Central Hospital
Yueyang, Hunan, China
The Third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Yichun People's Hospital
Yichun, Jiangxi, China
Hepatobiliary Hospital Of Jilin
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
The People's Hospital of Qinghai
Xining, Qinghai, China
Shandong Public Health Clinical Center
Jinan, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Ruian People's Hospital
Rui’an, Zhejiang, China
The First School of Medicine, School of Information and Engineering, The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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HY1001-2022-P3
Identifier Type: -
Identifier Source: org_study_id
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