Clinical trial NCT01813630: A Clinical Study to Assess the Efficacy and Safety of DA-3002
Official title: Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Patients With Turner's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Turner's Syndrome
Keywords: Turner's Syndrome
Short Stature
Dwarfism
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 58
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
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®.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Turner's Syndrome through chromosome analysis
* The chronological age: 2≤AGE≤12
* The yearly growth rate should be less than 6cm; the bone age should be equal or less than 12; the height ≤ 10th percentile for the heights of their agemates
* Before the adolescence, Tuner stage I (breast)
* 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

Primary outcomes:
measure: Annualized height velocity(cm/year) after 52 weeks
timeFrame: 52 weeks
Secondary outcomes:
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)
timeFrame: 52 weeks
measure: Changes in IGF-1
timeFrame: 52 weeks
measure: Changes in IGFBP-3
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: Asan Medical Center
name: Han Wook Yoo, 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: Seoul Medical Center
name: Dong Kyu Jin, 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 J, Kim MS, Suh BK, Ko CW, Lee KH, Yoo HW, Shin CH, Hwang JS, Kim HS, Chung WY, Kim CJ, Han HS, Jin DK. Recombinant growth hormone therapy in children with Turner Syndrome in Korea: a phase III Randomized Trial. BMC Endocr Disord. 2021 Dec 10;21(1):243. doi: 10.1186/s12902-021-00904-5.