Growth Hormone DeficiencyNCT04798690
Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
An observational study of Growth Hormone Deficiency and Idiopathic Short Stature, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Growth Hormone Deficiency, Idiopathic Short Stature, Turner Syndrome
- How many people
- 5,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Feb 2021to Feb 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Short stature by GHD or ISS or TS or SGA
Who may be able to join
- 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
Who cannot join
- Children with Epiphyseal closure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul, Seodaemun-gu, 03722
Ho Seong Kim, M.D., Ph.D, +82-2-2228-2069, kimho@yuhs.ac
About this study
Official title: Open, Multi-center, Non-interventional, Prospective/ Retrospective Observational Study on Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.
- Conditions
- Growth Hormone Deficiency, Idiopathic Short Stature, Turner Syndrome, Small for Gestational Age
- Medical subject headings
- Dwarfism, Pituitary, Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Growth hormone | Growtropin®-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety assessed through the adverse events
Number of occurrence of treatment-related adverse events
Measured: Up to 2 years after epiphyseal closure
Secondary outcomes (7)
Change of annualized height velocity
To assess the difference in change of annualized height velocity between baseline and every 6 months
Measured: Up to 2 years after epiphyseal closure
The difference between target height and final height
To assess the difference in target height and final height
Measured: Up to 2 years after epiphyseal closure
Changes in Height SDS
To assess the changes in Height SDS between baseline and every 6 months
Measured: Up to 2 years after epiphyseal closure
Changes in skeletal maturity
To assess the changes in skeletal maturity between baseline and every 6 months
Measured: Up to 2 years after epiphyseal closure
Changes in IGF-1
To assess the changes in IGF-1 between baseline and every 6 months
Measured: Up to 2 years after epiphyseal closure
Changes in IGFBP-3
To assess the changes in IGFBP-3 between baseline and every 6 months
Measured: Up to 2 years after epiphyseal closure
Changes in BMI SDS
To assess the changes in BMI SDS between baseline and every 6 months
Measured: Up to 2 years after epiphyseal closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start8 Feb 2021
- Primary completionFeb 2035 (estimated)
- Study completionFeb 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798690
- Sponsor's protocol ID
- DA3002_SS_OS
- Status last verified
- Jul 2026
- First submitted
- 17 Feb 2021
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multi-center, Non-interventional, Prospective/ Retrospective Observational Study on Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
- ClinicalTrials.gov ID
- NCT04798690
- Acronym / sponsor ID
- DA3002_SS_OS
- Conditions
- Growth Hormone Deficiency, Idiopathic Short Stature, Turner Syndrome, Small for Gestational Age
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- Feb 2035 (estimated)
- Study completion
- Feb 2035 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Growth hormone | – | –Growtropin®-II |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Short stature by GHD or ISS or TS or SGA
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Children with Epiphyseal closure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long term safety assessed through the adverse events
Time frame: Up to 2 years after epiphyseal closure
Number of occurrence of treatment-related adverse events
7 secondary outcomes
Change of annualized height velocity
Time frame: Up to 2 years after epiphyseal closure
The difference between target height and final height
Time frame: Up to 2 years after epiphyseal closure
Changes in Height SDS
Time frame: Up to 2 years after epiphyseal closure
Changes in skeletal maturity
Time frame: Up to 2 years after epiphyseal closure
Changes in IGF-1
Time frame: Up to 2 years after epiphyseal closure
Changes in IGFBP-3
Time frame: Up to 2 years after epiphyseal closure
Changes in BMI SDS
Time frame: Up to 2 years after epiphyseal closure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency and Idiopathic Short Stature, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung (+82-2-920-8369, jhsung@donga.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term safety assessed through the adverse events (time frame: Up to 2 years after epiphyseal closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.