Treatment of Adults With Growth Hormone Deficiency

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: LG Life Sciences
• Collaborator: BioPartners GmbH
• Treatments: Hormones

Criteria

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