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

A vizsgálat adatai

Ki végzi

Healthgen Biotechnology Corp.

Azonosító

NCT06355479

A regiszteradat frissítve

2024. április 9.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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

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.

Main Inclusion Criteria:; Diagnosis of hepatic cirrhosis; Adult males or females, aged 18-75 years (both inclusive) at the time of consent; Serum albumin level ≤ 30 g/L; 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:; 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.

ClinicalTrials.gov NCT06355479