NCT06355479已完成3 期
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
Healthgen Biotechnology Corp.37 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2023年4月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 328
- 试验地点
- 37
- 主要终点
- To evaluate the efficacy of OsrHSA on elevating the serum albumin level.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
OsrHSA
Experimental
OsrHSA 20g, IV qd, Day1 up to Day 14
干预措施: OsrHSA (Drug)
pHSA
Active Comparator
pHSA 20g, IV qd, Day1 up to Day 14
干预措施: Plasbumin®-20 (Drug)
结局指标
主要结局
To evaluate the efficacy of OsrHSA on elevating the serum albumin level.
时间窗: 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.
次要结局
- To estimate the change from baseline in serum albumin(Day 1 to Day 14)
- To estimate the time to reach 35 g/L or more in serum albumin(Day 1 to Day 14)
- To estimate the change from baseline in body weight(Day 1 to Day 14)
- To estimate the change from baseline in colloid osmotic pressure(Day 1 to Day 14)
- To estimate the change from baseline in abdominal circumference, and ascites severity(Day 1 to Day 14)
- To estimate the change from baseline in ascites severity(Day 1 to Day 14)
研究者
研究点 (37)
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