Adult Growth Hormone Deficiency, Growth Hormone Disorder
Conditions
Brief summary
This trial is conducted in Japan. This protocol describes an extension trial to supply hGH to subjects who wish continuous treatment after the long-term Phase 3 trial (GHLiquid-1519) until hGH products have been approved for GHDA in Japan.
Interventions
DRUGsomatropin
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 67 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who completed GHLiquid-1519. * If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded. * Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies.
Exclusion criteria
* Subject with a history of acromegaly. * Subject with diabetes mellitus. * Subject suffering from malignancy. * Several medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lipid-related laboratory tests parameters (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride) | at the end of treatment |
| GH-related laboratory parameters (IGF-I, IGF-I SDS, IGFBP-3, IGFBP-3 SDS and IGF-I / IGFBP-3 molar ratio) | at the end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
| FPG, insulin, and HbA1C | — |
| Clinical laboratory tests | — |
Countries
Japan
Outcome results
None listed