Overview

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

Status:
Completed
Trial end date:
2014-12-17
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Hormones
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