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

Turner's Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813630
• Other study ID #: DA3002_TS_III
• Status: Completed
• Phase: Phase 3
• Start date: February 2013
• Est. completion date: May 2018

Study information

• Verified date: July 2018
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome
• Turner's Syndrome

Intervention

Drug:
• DA-3002

• Genotropin®

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in anti-growth hormone antibody		52 weeks
Primary	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	Changes in height standard deviation score after 52 weeks		52 weeks
Secondary	Changes in bone maturation(changes in bone ages/changes in chronological age)		52 weeks
Secondary	Changes in IGF-1		52 weeks
Secondary	Changes in IGFBP-3		52 weeks