[Translation] A multicenter, randomized, open-label, active-controlled Phase II/III clinical trial to evaluate QHRD211 injection in the treatment of growth disorders in children caused by endogenous growth hormone deficiency
主要目的:
探索不同剂量QHRD211注射液治疗因内源性生长激素缺乏所造成的儿童生长障碍的有效性、安全性、耐受性、PK/PD特征和免疫原性,探索给药剂量、给药间隔、血药浓度与剂量效应关系,确定Ⅲ期临床试验用法、用量。
次要目的:
比较QHRD211注射液、重组人生长激素注射液(赛增)和聚乙二醇重组人生长激素注射液(金赛增)的有效性、安全性、PK/PD特征。
探索性目的:
评价QHRD211注射液是否通过以下方式对目标人群产生的有益影响:
1)提高受试者的治疗依从性。
2)减轻受试者的疾病家庭负担。
[Translation] Main purpose:
To explore the efficacy, safety, tolerability, PK/PD characteristics and immunogenicity of different doses of QHRD211 injection in the treatment of growth disorders in children caused by endogenous growth hormone deficiency, explore the relationship between dosage, dosing interval, blood drug concentration and dose effect, and determine the usage and dosage of Phase III clinical trials.
Secondary purpose:
To compare the efficacy, safety and PK/PD characteristics of QHRD211 injection, recombinant human growth hormone injection (Saizen) and polyethylene glycol recombinant human growth hormone injection (Jinsaizen).
Exploratory purpose:
To evaluate whether QHRD211 injection has beneficial effects on the target population in the following ways:
1) Improve the treatment compliance of the subjects.
2) Reduce the disease burden on the family of the subjects.