Treatment of Adults With Growth Hormone Deficiency

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.

Inclusion Criteria:

• Patients (male and female) who have completed the Visit 8 of preceding main study (BPLG-005) and are willing to continue their participation in an extension study
• If female, women of child-bearing potential who are using a reliable method of contraception and be willing to use it throughout the study. A negative urine pregnancy test at Visit 0 is required for females of child-bearing potential
• Written informed consent of the patient

Exclusion Criteria:

• Evidence of active malignancy or growth of a previously stable tumor
• Benign intracranial hypertension
• Clinically significant respiratory, cardiac, hepatic, renal, neuromuscular disease
• Non-compliance with medications, un-cooperativeness or drug abuse during the BPLG-005 study
• Patients who are not able to comply with the study protocol for any reason