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Completed

NCT Number: NCT02770157

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

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

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Key information

Conditions

Infant, Small for Gestational Age

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-3002

Drug

Genotropin®

Drug

Primary outcomes

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

    Time frame: 52 weeks

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

Secondary outcomes

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

    Time frame: 26 weeks

    Height velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.

  2. Changes in height standard deviation score after 52 weeks

    Time frame: 52 weeks

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

    Time frame: 52 weeks

  4. Changes in IGF-1 after 52 weeks

    Time frame: 52 weeks

  5. Changes in IGFBP-3 after 52 weeks

    Time frame: 52 weeks

Other outcomes

  1. Changes in anti-growth hormone antibody

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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.

Acronym: SGA

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 12, 2016
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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