Primary outcomeMean· 26 weeks
Annualized Height Velocity(cm/Year) After 26 Weeks
| Group | Value (cm/year) | Spread |
|---|---|---|
| DA-3002 Treatment Group | 10.68 | 1.95 |
| Non-treatment Control Group | 5.72 | 1.72 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy and Safety of DA-3002 in Children With Idiopathic Short Stature
NCTNCT01786902 (opens ClinicalTrials.gov in a new tab)Other idDA3002_ISS_III
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 70 participants (actual)
- Sponsor
- Dong-A ST Co., Ltd. · Industry
- Design
- Randomized · Open label (no masking)
- Countries
- Not stated
- Start
- Feb 2012
- Primary completion
- Apr 2014
- Completion
- Apr 2014
- First posted
- 8 Feb 2013 (estimated)
- Last update posted
- 19 Oct 2017
- Conditions
- Idiopathic Short Stature
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2012201320142015
- Ph 3
Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature
NCT01786902Feb 2012 to Apr 2014
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.
Interventions
- DA-3002Drug
Arms2
Experimental
DA-3002 Treatment group
1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
No intervention
Non-treatment control group
Height be measured with no treatment
Primary outcomes1
Outcomes the sponsor listed as primary.
Annualized Height Velocity(cm/Year) After 26 Weeks
Time frame · 26 weeks
Registry description
Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.
Secondary outcomes(1)
Changes in Height Standard Deviation Score After 26 Weeks
Time frame · 26 weeks
Registry description
The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeMean· 26 weeks
Changes in Height Standard Deviation Score After 26 Weeks
| Group | Value (ratio) | Spread |
|---|---|---|
| DA-3002 Treatment Group | 0.63 | 0.16 |
| Non-treatment Control Group | 0.06 | 0.15 |
Other pre specified outcomeMean· baseline and 26 weeks
Changes in Anti-growth Hormone Antibody
| Group | Value (ng/mL) | Spread |
|---|---|---|
| DA-3002 Treatment Group | 0.30 | 0.35 |
| Non-treatment Control Group | 0.21 | 0.54 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| DA-3002 Treatment Group1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week) DA-3002 | – | 1 / 36 | 19 / 36 |
| Non-treatment Control GroupHeight be measured with no treatment | – | 1 / 31 | 14 / 31 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 4 Years up to 13 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Chronological Age ≥ 4
* Bone Age \<11 (for girls) and \<13 (for boys)
* Height \<3rd percentile for age
* normal thyroid function
Exclusion Criteria:
* endocrine and/or metabolic disorders
* growth failure caused by other disorders
* previous use of drugs that could interfere with Growth Hormone treatment
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