Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsrHSA | Experimental | OsrHSA 20g, IV qd, Day1 up to Day 14 |
|
| pHSA | Active Comparator | pHSA 20g, IV qd, Day1 up to Day 14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsrHSA | Drug | Recombinant Human Serum Albumin from Oryza Sativa |
| |
| 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 |
| 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 |
Not provided
Main Inclusion Criteria:
Main Exclusion Criteria:
History of allergy to rice; a history of allergy to any component of the HpHSA product
Therapeutic/ Large-volume paracentesis (> 5L each time) during the treatment period
Ascites resulted from non-hepatic cirrhosis, Budd-Chiari syndrome
Participants with Grade III or Grade IV hepatic encephalopathy using West Heaven Criteria
A transjugular intrahepatic peritoneal shunt (TIPS) is performed within 1 month prior to the first dosing
Evidence of upper gastrointestinal hemorrhage 6 months prior to the first dosing
Participants with stage C and stage D hepatocellular carcinoma according to China Liver Cancer Staging (CNLC) Classification
Evidence of extrahepatic neoplastic disorders
Transplantation
HIV positive
Participants with pleural effusion and need therapeutic thoracentesis during the treatment period
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.
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.
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%
Pregnant or breastfeeding or plan to get pregnant in 6 months
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);
Enrolled in any clinical trials within 3 months prior to the first dose of study intervention
Any other condition that the investigator considers would make the participant unsuitable for the clinical trial
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | China | |||
| Beijing Youan Hospital, Capital Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Plasbumin®-20 |
| Drug |
Albumin (Human) 20%, USP |
|
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 |
| 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 |
| ID | Term |
|---|---|
| D034141 | Hypoalbuminemia |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D007019 | Hypoproteinemia |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided