Clinical trial NCT02770157: Efficacy and Safety of DA-3002 in Short Children Borns SGA.
Official title: Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Short Children Born Small for Gestational Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infant, Small for Gestational Age
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-05-12
Enrollment: 75
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Chronological Age ≥ 4
* Before the adolescence, Tuner stage I (breast)
* Height \<3rd percentile for age
* Normal thyroid function

Exclusion Criteria:

* Growth hormone was administered for 12 months or longer in the past
* Treated with estrogen or adrenal androgens for 12 months or longer in the past
* Malignancy, CNS Trauma, Psychiatric Disorder
* endocrine and/or metabolic disorders
* growth failure caused by other disorders

Primary outcomes:
measure: Annualized height velocity(cm/year) after 52 weeks.
timeFrame: 52 weeks
Secondary outcomes:
measure: Annualized height velocity(cm/year) after 26 weeks.
timeFrame: 26 weeks
measure: Changes in height standard deviation score after 52 weeks
timeFrame: 52 weeks
measure: Changes in bone maturation(changes in bone ages/changes in chronological age) after 52 weeks
timeFrame: 52 weeks
measure: Changes in IGF-1 after 52 weeks
timeFrame: 52 weeks
measure: Changes in IGFBP-3 after 52 weeks
timeFrame: 52 weeks
Other outcomes:
measure: Changes in anti-growth hormone antibody
timeFrame: 52 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Seoul Samsung Medical center.
name: Dong kyu Jin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St. Mary's Hospital, The Catholic University of Korea
name: Byung Kyu Suh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: Cheol Woo Ko, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: Kee Hyoung Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Han Wook Yoo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Choong Ho Shin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aju University Hospital
name: Jin Soon Hwang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Children's Hospital Yonsei University
name: Ho Seong Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan University Hospital
name: Woo Young Jeong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Chang Jong Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungbuk National University Hospital
name: Heon Suk Han, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.