Status:
COMPLETED
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Growth Hormone Disorder
Adult Growth Hormone Deficiency
Eligibility:
All Genders
19-67 years
Phase:
PHASE3
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 product...
Eligibility Criteria
Inclusion
- 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
- Subject with a history of acromegaly.
- Subject with diabetes mellitus.
- Subject suffering from malignancy.
- Several medical conditions
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00184730
Start Date
November 1 2004
End Date
September 1 2006
Last Update
November 17 2016
Active Locations (1)
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1
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005