|
|
|
|
|
|
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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(III期阶段)
[Translation] A randomized, double-blind, parallel-group Phase II/III clinical trial to evaluate the efficacy and safety of recombinant human serum albumin versus human serum albumin in patients with cirrhosis and ascites (Phase III stage)
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。
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和糖化血红蛋白的影响。
[Translation] Phase III stage
Main purpose:
Using the change of serum albumin concentration from baseline immediately after the last intravenous administration as an indicator, evaluate the efficacy of recombinant human serum albumin in patients with cirrhosis and ascites.
Secondary objectives:
1) Evaluate the efficacy of recombinant human serum albumin in patients with cirrhosis and ascites based on other efficacy evaluation indicators;
2) Evaluate the safety of recombinant human serum albumin in subjects with cirrhosis and ascites;
3) Evaluate the pharmacodynamic (PD) characteristics of recombinant human serum albumin in subjects with cirrhosis and ascites;
4) Evaluate the immunogenicity of recombinant human serum albumin in subjects with cirrhosis and ascites.
Exploratory purpose: To evaluate the effect of recombinant human serum albumin on glycated albumin and glycated hemoglobin in patients with cirrhosis and ascites.
/ RecruitingEarly Phase 1IIT To evaluate the safety and preliminary efficacy of recombinant human serum albumin injection in the treatment of mild to moderate Alzheimer's disease
/ Not yet recruitingPhase 3IIT A randomized, double-blind, parallel grouping phase II/III clinical trial to evaluate the efficacy and safety of recombinant human serum albumin versus human serum albumin in patients with cirrhosis and ascites
100 Clinical Results associated with Shenzhen Projee Medical Technology Co., Ltd.
0 Patents (Medical) associated with Shenzhen Projee Medical Technology Co., Ltd.
100 Deals associated with Shenzhen Projee Medical Technology Co., Ltd.
100 Translational Medicine associated with Shenzhen Projee Medical Technology Co., Ltd.