Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
Status and phase
Completed
Phase 3
Conditions
Adult Growth Hormone Deficiency
Growth Hormone Disorder
Treatments
Drug: somatropin
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
86 patients
Sex
All
Ages
19 to 67 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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