COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Treatment of Adults With Growth Hormone Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00596037
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : October 5, 2012
BioPartners GmbH
Information provided by (Responsible Party):
LG Life Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Pituitary Disorders Adult Growth Hormone Deficiency Drug: Growth hormone - LB03002 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: LB03002 throughout
administered LB03002 for preceding 26 weeks
Drug: Growth hormone - LB03002
Experimental: Switched to LB03002
administered placebo for preceding 26 weeks
Drug: Growth hormone - LB03002

Primary Outcome Measures :
  1. Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005 [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   23 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00596037

Sponsors and Collaborators
LG Life Sciences
BioPartners GmbH
Layout table for investigator information
Study Chair: HJ Ji, PhD LG Life Sciences
Layout table for additonal information
Responsible Party: LG Life Sciences Identifier: NCT00596037    
Other Study ID Numbers: BPLG-005-RO
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: October 5, 2012
Last Verified: October 2012
Keywords provided by LG Life Sciences:
Growth hormone Deficiency
Additional relevant MeSH terms:
Layout table for MeSH terms
Dwarfism, Pituitary
Pituitary Diseases
Endocrine System Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs