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Treatment of Adults With Growth Hormone Deficiency

This study has been completed.
Sponsor:
Collaborator:
BioPartners GmbH
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT00596037
First received: January 7, 2008
Last updated: October 4, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Pituitary Disorders
Adult Growth Hormone Deficiency
 Drug: Growth hormone - LB03002
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by LG Life Sciences:

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

Enrollment: 136
Study Start Date: August 2006
Study Completion Date: May 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   23 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596037

Sponsors and Collaborators
LG Life Sciences
BioPartners GmbH
Investigators
Study Chair: HJ Ji, PhD LG Life Sciences
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT00596037     History of Changes
Other Study ID Numbers: BPLG-005-RO
Study First Received: January 7, 2008
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by LG Life Sciences:
Growth hormone Deficiency

Additional relevant MeSH terms:
Dwarfism, Pituitary
Pituitary Diseases
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013