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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

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