Hepatic Cirrhosis, Hypoalbuminemia
Conditions
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.
Interventions
DRUGOsrHSA
Recombinant Human Serum Albumin from Oryza Sativa
DRUGPlasbumin®-20
Albumin (Human) 20%, USP
Sponsors
Healthgen Biotechnology Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of OsrHSA on elevating the serum albumin level. | Day 1 to Day 14 | Percentage of participants whose albumin level reaches 35 g/L or above at any time up to 14 days of the study intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To estimate the change from baseline in serum albumin | Day 1 to Day 14 | To estimate the change from baseline to the end of treatment (EOT) in serum albumin |
| To estimate the change from baseline in colloid osmotic pressure | Day 1 to Day 14 | The change from baseline to the end of treatment (EOT) will be measured in Colloid osmotic pressure |
| To estimate the time to reach 35 g/L or more in serum albumin | Day 1 to Day 14 | Time to reach serum albumin 35 g/L or more by the end of the treatment (EOT) |
| To estimate the change from baseline in abdominal circumference, and ascites severity | Day 1 to Day 14 | The change in abdominal circumferences will be measured from baseline to the end of treatment (EOT) |
| To estimate the change from baseline in ascites severity | Day 1 to Day 14 | The change in ascites severity will be measured from baseline to the end of treatment (EOT) |
| To estimate the change from baseline in body weight | Day 1 to Day 14 | The change in body weight will be measured from baseline to the end of treatment (EOT) |
Countries
China
Outcome results
None listed