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Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

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Novo Nordisk

Status and phase

Completed
Phase 3

Conditions

Adult Growth Hormone Deficiency
Growth Hormone Disorder

Treatments

Drug: somatropin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00184730
GHLIQUID-1650
JapicCTI-050134 (Registry Identifier)

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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