Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Idiopathic Short Stature; Growth Disorder

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01778023

U1111-1125-4790 (Other Identifier)

GH-3899

2015-002613-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

hGH:12months treatment

Experimental group

Treatment:

Drug: somatropin

hGH: 6 month un-treatment + 6 month treatment

Active Comparator group

Treatment:

Drug: somatropin