NCT01813630

Brief Summary

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2013

Longer than P75 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 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

5.2 years

First QC Date

March 15, 2013

Last Update Submit

July 24, 2018

Conditions

Turner's Syndrome

Keywords

Turner's SyndromeShort StatureDwarfism

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 (4)

  • Changes in height standard deviation score after 52 weeks

    52 weeks

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

    52 weeks

  • Changes in IGF-1

    52 weeks

  • Changes in IGFBP-3

    52 weeks

Other Outcomes (1)

  • Changes in anti-growth hormone antibody

    52 weeks

Study Arms (2)

DA-3002

EXPERIMENTAL

0.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas

Drug: DA-3002

Genotropin®

ACTIVE COMPARATOR

0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas

Drug: Genotropin®

Interventions

DA-3002DRUG
DA-3002
Genotropin®DRUG
Genotropin®

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 34893062DERIVED

MeSH Terms

Conditions

Turner SyndromeDwarfism

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Gonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSex Chromosome DisordersChromosome DisordersGenetic Diseases, InbornGonadal DisordersEndocrine System DiseasesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Han Wook Yoo, M.D., Ph.D.

    Asan 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

  • Dong Kyu Jin, M.D.,Ph.D.

    Seoul 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

March 15, 2013

First Posted

March 19, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

KR(1)