Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
Phase 3
Completed
- Conditions
- Adult Growth Hormone DeficiencyGrowth Hormone Disorder
- Registration Number
- NCT00184730
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Adverse events FPG, insulin, and HbA1C Clinical laboratory tests
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
šÆšµTokyo, Japan