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Completed

NCT Number: NCT01813630

A Clinical Study to Assess the Efficacy and Safety of DA-3002

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

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Key information

Conditions

Turner's Syndrome Bone Diseases Bone Diseases, Developmental Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Dwarfism Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Gonadal Dysgenesis Heart Defects, Congenital Heart Diseases Male Urogenital Diseases Musculoskeletal Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Turner Syndrome Urogenital Abnormalities Urogenital Diseases

Age range

2 year–12 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

  • 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

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. Changes in height standard deviation score after 52 weeks

    Time frame: 52 weeks

  2. Changes in bone maturation(changes in bone ages/changes in chronological age)

    Time frame: 52 weeks

  3. Changes in IGF-1

    Time frame: 52 weeks

  4. Changes in IGFBP-3

    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 Patients With Turner's Syndrome

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2013
Registry last updated
Jul 26, 2018

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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