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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-3002 Treatment group | Experimental | 1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week) |
|
| Non-treatment control group | No Intervention | Height be measured with no treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-3002 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Height Velocity(cm/Year) After 26 Weeks | Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Height Standard Deviation Score After 26 Weeks | 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. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Anti-growth Hormone Antibody | baseline and 26 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanwook Yoo, MD | Asan Medical Center | Principal Investigator |
| Byungkyu Suh, MD | Seoul St. Mary's Hospital | Study Director |
| Cheolwoo Ko, MD | Kyungpook National University Hospital | Study Director |
| Keehyoung Lee, MD | Korea University Anam Hospitial | Study Director |
| Dongkyu Jin, MD | Samsung Medical Center | Study Director |
| Choongho Shin, MD | Seoul National University Hospital | Study Director |
| Jinsoon Hwang, MD | Aju University Hospital | Study Director |
| Hoseong Kim, MD | Severance Children's Hospital Yonsei University | Study Director |
| Wooyoung Jeong, MD | Pusan University Hospital | Study Director |
| Chanjong Kim, MD | Chonnam National University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) DA-3002 |
| FG001 | Non-treatment Control Group | Height be measured with no treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) DA-3002 |
| BG001 | Non-treatment Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Annualized Height Velocity(cm/Year) After 26 Weeks | Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate. | Posted | Mean | Standard Deviation | cm/year | 26 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) DA-3002 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngotonsillitis | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enteritis | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hanwook Yoo | Asan Medical Center | 82-2-3010-3374 | hwyoo@amc.seoul.kr |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Study Director |
| Heonsuk Han, MD | Chungbuk National University Hospital | Study Director |
Height be measured with no treatment
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Changes in Height Standard Deviation Score After 26 Weeks | 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 | Mean | Standard Deviation | ratio | 26 weeks |
|
|
|
| Other Pre-specified | Changes in Anti-growth Hormone Antibody | Posted | Mean | Standard Deviation | ng/mL | baseline and 26 weeks |
|
|
|
| 1 |
| 36 |
| 19 |
| 36 |
| EG001 | Non-treatment Control Group | Height be measured with no treatment | 1 | 31 | 14 | 31 |
| Strabismus correction | Surgical and medical procedures |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Laceration | Injury, poisoning and procedural complications |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Strabismus correction | Surgical and medical procedures |
|
| Pyrexia | General disorders |
|
| Hypersensitivity | Immune system disorders |
|
| Upper respiratory tract infection | Infections and infestations |
|
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |