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项与 重组人血清白蛋白(北京普罗吉) 相关的临床试验An Open-label, Parallel-group Exploratory Clinical Trial to Evaluate the Safety and Preliminary Efficacy of Recombinant Human Serum Albumin Injection in the Treatment of Mild to Moderate Alzheimer's Disease
This clinical trial is an open-label, parallel-group, exploratory study of recombinant human serum albumin (rHSA, hereafter referred to as the "investigational drug") in patients with mild to moderate Alzheimer's Disease (AD). It aims to enroll 30 subjects who meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for "Probable AD Dementia." Participants will be randomized in a 1:1:1 ratio to receive the investigational drug at doses of 20g, 30g, or 40g, for assessments of safety and preliminary efficacy. Stratification factors will be based on the severity classification (mild; moderate) as indicated by the total score on the Clinical Dementia Rating Scale - Global Score (CDR-GS) during the screening period.
To Evaluate the Effectiveness of Recombinant Human Serum Albumin Versus Human Serum Albumin in Patients With Hepatic Cirrhosis and Safety of Random, Double-blind, Parallel Grouping Phase II/III Clinical Trial
This is a randomized, double-blind, position-controlled, parallel group phase II/III clinical study of recombinant human serum albumin (rHSA) in cirrhotic ascites patients.
评价重组人血清白蛋白对比人血白蛋白在肝硬化腹水患者中的有效性和安全性的随机、双盲、平行分组的II/III 期临床试验
II 期阶段
? 主要目的:
评价重组人血清白蛋白对提高肝硬化腹水患者血清白蛋白水平的疗效,以及剂量
和疗效的关系。
? 次要目的:
1) 评价重组人血清白蛋白在肝硬化腹水受试者中的安全性;
2) 评价重组人血清白蛋白在肝硬化腹水受试者中的药效动力学(PD)特征;
3) 评价重组人血清白蛋白在肝硬化腹水受试者中的免疫原性。
? 探索性目的:评价重组人血清白蛋白对于肝硬化腹水患者糖化白蛋白的影响。
III 期阶段
? 主要目的:
以末次静脉给药完成后即刻血清白蛋白浓度较基线变化为指标,评价重组人血清
白蛋白在肝硬化腹水患者中的疗效。
? 次要目的:
1) 基于其他疗效评价指标评价重组人血清白蛋白在肝硬化腹水患者中的疗效;
2) 评价重组人血清白蛋白在肝硬化腹水受试者中的安全性;
3) 评价重组人血清白蛋白在肝硬化腹水受试者中的药效动力学(PD)特征;
4) 评价重组人血清白蛋白在肝硬化腹水受试者中的免疫原性。
100 项与 重组人血清白蛋白(北京普罗吉) 相关的临床结果
100 项与 重组人血清白蛋白(北京普罗吉) 相关的转化医学
100 项与 重组人血清白蛋白(北京普罗吉) 相关的专利(医药)
100 项与 重组人血清白蛋白(北京普罗吉) 相关的药物交易