Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature
- Registration Number
- NCT01778023
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Informed consent obtained from subject's parents or legally acceptable representative before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- Pre-pubertal status (males aged from 4 to 11 [both inclusive], females aged from 4 to 9 [both inclusive]): an absence of breast development in females (Tanner 1 only) and testicular volume below 4 mL in males
- Growth hormone level above 10 ng/mL following a stimulation test (test result within 6 months from screening can be used)
- Height below 3 percentile
- Bone age below or equal to 12 year
- Epiphyses confirmed as open in patients at least 10 years or more of age
- Known presence of one or more pituitary hormone deficiencies (ACTH (adrenocorticotropic hormone), ADH (antidiuretic hormone), FSH (follicle-stimulating hormone), LH (luteinising hormone), TSH (thyroid-stimulating hormone))
- Known primary hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated)
- Specific types of growth failure including, but not limited to, known chromosomal abnormalities associated with growth failure and altered sensitivity to growth hormone
- Bone age is advanced over chronological age more than 3 years
- Active malignancy, CNS (central nervous system) trauma, active chemotherapy or radiation therapy for neoplasia
- Prior history of intracranial hypertension
- Hypertrophic cardiomyopathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hGH: 6 month un-treatment + 6 month treatment somatropin - hGH:12months treatment somatropin -
- Primary Outcome Measures
Name Time Method Height Velocity (Ht-V) After 6 months of treatment 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.
- Secondary Outcome Measures
Name Time Method Ht-V (Height Velocity) At the first 6 months and the last 6 months in group A 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.
Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3) After 6 months of treatment. 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.
Change in Ht-SDS (Height Standard Deviation Score) After 6 months of treatment. 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.
Change in Bone Age After 6 months of treatment. Change in bone age from the baseline to 6 months.
Occurrence of Adverse Events Throughout the trial (12 months) AEs were collected throughout the trial in both groups.
Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I) After 6 months of treatment. 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.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇰🇷Suwon, Korea, Republic of