NCT02770157

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2019

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

3.5 years

First QC Date

May 10, 2016

Last Update Submit

October 13, 2019

Conditions

Infant, Small for Gestational Age

Outcome Measures

Primary Outcomes (1)

  • Annualized height velocity(cm/year) after 52 weeks.

    Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate.

    52 weeks

Secondary Outcomes (5)

  • Annualized height velocity(cm/year) after 26 weeks.

    26 weeks

  • Changes in height standard deviation score after 52 weeks

    52 weeks

  • Changes in bone maturation(changes in bone ages/changes in chronological age) after 52 weeks

    52 weeks

  • Changes in IGF-1 after 52 weeks

    52 weeks

  • Changes in IGFBP-3 after 52 weeks

    52 weeks

Other Outcomes (1)

  • Changes in anti-growth hormone antibody

    52 weeks

Study Arms (3)

DA-3002

EXPERIMENTAL

1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week).

Drug: DA-3002

Genotropin®

ACTIVE COMPARATOR

1.44 IU (0.48mg)/kg/week of Genotropin is injected for 52 weeks by changing injecting areas(six or seven times per week).

Drug: Genotropin®

Non-treatment control group

OTHER

After no treatment for 26 weeks, 1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week).

Drug: DA-3002

Interventions

DA-3002DRUG
DA-3002Non-treatment control group
Genotropin®DRUG
Genotropin®

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 34397702DERIVED

MeSH Terms

Interventions

Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Dong kyu Jin, M.D., Ph.D.

    Seoul Samsung Medical center.

    PRINCIPAL INVESTIGATOR

  • Byung Kyu Suh, M.D., Ph.D.

    Seoul St. Mary's Hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Cheol Woo Ko, M.D., Ph.D.

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

  • Kee Hyoung Lee, M.D., Ph.D.

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

  • Han Wook Yoo, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

  • Choong Ho Shin, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

  • Jin Soon Hwang, M.D., Ph.D.

    Aju University Hospital

    PRINCIPAL INVESTIGATOR

  • Ho Seong Kim, M.D., Ph.D.

    Severance Children's Hospital Yonsei University

    PRINCIPAL INVESTIGATOR

  • Woo Young Jeong, M.D., Ph.D.

    Pusan University Hospital

    PRINCIPAL INVESTIGATOR

  • Chang Jong Kim, M.D., Ph.D.

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

  • Heon Suk Han, M.D., Ph.D.

    Chungbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 12, 2016

Study Start

February 26, 2016

Primary Completion

August 28, 2019

Study Completion

August 28, 2019

Last Updated

October 16, 2019

Record last verified: 2019-10

Locations

KR(1)