Clinical trial NCT01778023: Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature
Official title: A 12-month, Open-labelled, Randomised, Parallel-group, Multi-centre, Interventional Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone (hGH) (Norditropin® Nordilet®) Therapy on Height Velocity (Ht-V) in Patients With Idiopathic Short Stature in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Disorder
Idiopathic Short Stature
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-01-29
Enrollment: 54
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Height Velocity (Ht-V)
timeFrame: After 6 months of treatment
Secondary outcomes:
measure: Change in Ht-SDS (Height Standard Deviation Score)
timeFrame: After 6 months of treatment.
measure: Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)
timeFrame: After 6 months of treatment.
measure: Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)
timeFrame: After 6 months of treatment.
measure: Change in Bone Age
timeFrame: After 6 months of treatment.
measure: Occurrence of Adverse Events
timeFrame: Throughout the trial (12 months)
measure: Ht-V (Height Velocity)
timeFrame: At the first 6 months and the last 6 months in group A
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Daegu
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Suwon
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Safety and Efficacy Evaluation of Human Growth Hormone (GH) Therapy in Patients with Idiopathic Short Stature (ISS) in Korea - a Randomized Controlled Trial; Min Ho Jung, Byung-Kyu Suh, Cheol Woo Ko et al.; 028-042-GH-Pediatrics (posters) ENDO meeting 2016, Boston Massachusetts
citation: Jung MH, Suh BK, Ko CW, Lee KH, Jin DK, Yoo HW, Hwang JS, Chung WY, Han HS, Prusty V, Kim HS. Efficacy and Safety Evaluation of Human Growth Hormone Therapy in Patients with Idiopathic Short Stature in Korea - A Randomised Controlled Trial. Eur Endocrinol. 2020 Apr;16(1):54-59. doi: 10.17925/EE.2020.16.1.54. Epub 2019 Oct 15.