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A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency
The objective of this rollover study is to evaluate the long term (1 year) safety of a new weekly administered growth hormone preparation in adults with growth hormone deficiency who were treated with the same experimental preparation in study BPLG-005. In addition, further change in efficacy endpoints of BPLG-005 by prolonged treatment will be evaluated. Additional efficacy and safety data of the experimental preparation will be obtained from the switch-over patients.
Details
| Lead sponsor | LG Life Sciences |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 136 |
| Start date | 2006-08 |
| Completion | 2009-05 |
Conditions
- Pituitary Disorders
- Adult Growth Hormone Deficiency
Interventions
- Growth hormone - LB03002
Primary outcomes
- Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005 — 1 year