Treatment of Adults With Growth Hormone Deficiency

Adult Growth Hormone Deficiency Clinical Trial

Official title:

A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596037
• Other study ID #: BPLG-005-RO
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2008
• Last updated: October 4, 2012
• Start date: August 2006
• Est. completion date: May 2009

Study information

• Verified date: October 2012
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases
• Pituitary Diseases
• Pituitary Disorders

Intervention

Drug:
• Growth hormone - LB03002

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
LG Life Sciences	BioPartners GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005		1 year	Yes