drugset

drugset / Trial / NCT02770157

Efficacy and Safety of DA-3002 in Short Children Borns SGA.

NCT02770157 ↗

Phase 3 Completed 75 enrolled Dong-A ST Co., Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.

Timeline

Start: 2016-02-26
Primary completion: 2019-08-28
Completion: 2019-08-28

Publications

Kim SJ, Kim MS, Cho SY, Suh BK, Ko CW, Lee KH, Yoo HW, Shin CH, Hwang JS, Kim HS, Chung WY, Kim CJ, Han HS, Jin DK. Efficacy and safety of the recombinant human growth hormone in short children born small for gestational age: A randomized, multicentre, comparative phase III trial. Medicine (Baltimore). 2021 Jul 30;100(30):e26711. doi: 10.1097/MD.0000000000026711.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DA-3002	Protein / enzyme biologic	0.48 mg/kg	Subcutaneous
Comparator	Somatropin	Protein / enzyme biologic	0.48 mg/kg	Subcutaneous

Indications