A Phase 3 interventional study of somatropin in Growth Disorder and Idiopathic Short Stature, sponsored by Novo Nordisk A/S. Completed at 8 sites in Korea, Republic of. Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2017-06-02.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.
125 studies on the registry are indexed under Dwarfism; 19 are open to participants now.
This study's enrollment of 54 is below the median of 75 across 74 interventional studies indexed under Dwarfism.
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Exclusion Criteria:
Drug: somatropin
Drug: somatropin
A weekly dosage of 0.469 mg of somatropin per kg of body weight per week will be injected subcutaneously (under the skin) in the evening in 7 days per week.
Height Velocity (Ht-V)
Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.
Time frame: After 6 months of treatment
Change in Ht-SDS (Height Standard Deviation Score)
Height standard deviation scores (HSDS) were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from -2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal.
Time frame: After 6 months of treatment.
Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)
IGF-I (insulin-like growth factor-1) was measured at Visit 1 (screening),Visit 3 (3 months ± 7 days ),Visit 4 (6 months ± 7 days),Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6 months treatment was calculated.
Time frame: After 6 months of treatment.
Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)
IGFBP-3 was measured at Visit 1(screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), 5 (9 months ± 7 days ) and 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6 months treatment were calculated.
Time frame: After 6 months of treatment.
Change in Bone Age
Change in bone age from the baseline to 6 months.
Time frame: After 6 months of treatment.
Occurrence of Adverse Events
AEs were collected throughout the trial in both groups.
Time frame: Throughout the trial (12 months)
Ht-V (Height Velocity)
Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), 4 (6 months ± 7 days) and 6 (12 months ± 7 days), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment. This endpoint was only evaluated for Group A as per the trial protocol.
Time frame: At the first 6 months and the last 6 months in group A
The trial was conducted at 10 sites in Korea.
| Milestone | Group A: 12-month GH Treatment | Group B: 6-month Untreated + 6-month GH Treatment |
|---|---|---|
| Started | 36 | 18 |
| Exposed | 36 | 15 |
| Completed | 36 | 15 |
| Not completed | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 3 |
Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.
| cm/year | Group A: 12-month GH Treatment | Group B: 6-month Untreated + 6-month GH Treatment |
|---|---|---|
| Height Velocity (Ht-V) | 12.02 ± 0.29 | 6.87 ± 0.43 |
Height standard deviation scores (HSDS) were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from -2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal.
| Standard Deviation Score (SDS) | Group A: 12-month GH Treatment | Group B: 6-month Untreated + 6-month GH Treatment |
|---|---|---|
| Change in Ht-SDS (Height Standard Deviation Score) | 0.76 ± 0.04 | 0.19 ± 0.06 |
IGF-I (insulin-like growth factor-1) was measured at Visit 1 (screening),Visit 3 (3 months ± 7 days ),Visit 4 (6 months ± 7 days),Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6 months treatment was calculated.
| ng/ml | Group A: 12-month GH Treatment | Group B: 6-month Untreated + 6-month GH Treatment |
|---|---|---|
| Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I) | 192.58 ± 14.00 | 28.03 ± 21.81 |
IGFBP-3 was measured at Visit 1(screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), 5 (9 months ± 7 days ) and 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6 months treatment were calculated.
| mcg/mL | Group A: 12-month GH Treatment | Group B: 6-month Untreated + 6-month GH Treatment |
|---|---|---|
| Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3) | 0.89 ± 0.19 | 0.22 ± 0.30 |
Change in bone age from the baseline to 6 months.
| years | Group A: 12-month GH Treatment | Group B: 6-month Untreated + 6-month GH Treatment |
|---|---|---|
| Change in Bone Age | 0.5 ± 0.2 | 0.5 ± 0.2 |
AEs were collected throughout the trial in both groups.
| events | Group A: 12-month GH Treatment | Group B: 6-month Untreated + 6-month GH Treatment |
|---|---|---|
| Occurrence of Adverse Events | 70 | 25 |
Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), 4 (6 months ± 7 days) and 6 (12 months ± 7 days), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment. This endpoint was only evaluated for Group A as per the trial protocol.
| cm/year | Group A: 12-month GH Treatment |
|---|---|
| Ht-V (Height Velocity) | 2.80 (1.55 to 4.04) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A: 12-month GH Treatment | — | 4/36 (11.1%) | 20/36 (55.6%) |
| Group B: 6-month Untreated + 6-month GH Treatment | — | 2/15 (13.3%) | 10/15 (66.7%) |
| Event | Group A: 12-month GH Treatment | Group B: 6-month Untreated + 6-month GH Treatment |
|---|---|---|
| PneumoniaInfections and infestations | 0/36 | 1/15 |
| Tonsillar hypertrophyRespiratory, thoracic and mediastinal disorders | 1/36 | 1/15 |
| HydroceleCongenital, familial and genetic disorders | 1/36 | 0/15 |
| PharyngotonsillitisInfections and infestations | 1/36 | 0/15 |
| Kawasaki's diseaseVascular disorders | 1/36 | 0/15 |
| Event | Group A: 12-month GH Treatment | Group B: 6-month Untreated + 6-month GH Treatment |
|---|---|---|
| NasopharyngitisInfections and infestations | 15/36 | 7/15 |
| RhinitisInfections and infestations | 0/36 | 2/15 |
| InfluenzaInfections and infestations | 3/36 | 0/15 |
| Upper respiratory tractInfections and infestations | 3/36 | 1/15 |
| UrticariaSkin and subcutaneous tissue disorders | 3/36 | 0/15 |
| Eye disorderEar and labyrinth disorders | 0/36 | 1/15 |
| Chest painGeneral disorders | 0/36 | 1/15 |
| ConjunctivitisInfections and infestations | 1/36 | 1/15 |
| Rhinitis allergicRespiratory, thoracic and mediastinal disorders | 0/36 | 1/15 |
| DermatitisSkin and subcutaneous tissue disorders | 0/36 | 1/15 |
| Age, Continuous(years) | Group A: 12-month GH Treatment | Group B: 6-month Untreated + 6-month GH Treatment | Total |
|---|---|---|---|
| Mean | 6.3 ± 1.5 | 5.9 ± 1.2 | 6.2 ± 1.5 |
| Sex: Female, Male(Participants) | Group A: 12-month GH Treatment | Group B: 6-month Untreated + 6-month GH Treatment | Total |
|---|---|---|---|
| Female | 17 | 6 | 23 |
| Male | 19 | 9 | 28 |
| Height(cm) | Group A: 12-month GH Treatment | Group B: 6-month Untreated + 6-month GH Treatment | Total |
|---|---|---|---|
| Mean | 107.7 ± 8.7 | 105.8 ± 7.5 | 107.1 ± 8.3 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S