Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorDong-A ST Co., Ltd.
About this trial
This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children with short stature by growth hormone deficiency(GHD) or idiopathic short stature (ISS) or turner's syndrome(TS) or small for gestational age(SGA)
Children who has official height record at least 6 months prior
Disqualifiers
Children with Epiphyseal closure
Trial population
Short stature by GHD or ISS or TS or SGA
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 1 trial groupGroup A: Growth hormone
Trial outcomes
Primary outcomes
1
Long term safety assessed through the adverse events
Number of occurrence of treatment-related adverse events
Time frame
Up to 2 years after epiphyseal closureSecondary outcomes
1
Change of annualized height velocity
To assess the difference in change of annualized height velocity between baseline and every 6 months
Time frame
Up to 2 years after epiphyseal closure2
The difference between target height and final height
To assess the difference in target height and final height
Time frame
Up to 2 years after epiphyseal closure3
Changes in Height SDS
To assess the changes in Height SDS between baseline and every 6 months
Time frame
Up to 2 years after epiphyseal closure4
Changes in skeletal maturity
To assess the changes in skeletal maturity between baseline and every 6 months
Time frame
Up to 2 years after epiphyseal closureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov