Treatment of Adults With Growth Hormone Deficiency - Full Text View

Sponsors and Collaborators:	LG Life Sciences BioPartners GmbH
Information provided by:	LG Life Sciences
ClinicalTrials.gov Identifier:	NCT00596037

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 III

Genetics Home Reference related topics: pseudoachondroplasia

MedlinePlus related topics: Pituitary Disorders

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	150
Study Start Date:	August 2006
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

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

Locations

United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States

Sponsors and Collaborators

LG Life Sciences

BioPartners GmbH

Investigators

Study Chair:

HJ Ji, PhD

LG Life Sciences

More Information

Responsible Party:	LG Life Sciences ( Songmi Lee/Clinical Research Manager )
Study ID Numbers:	BPLG-005-RO
Study First Received:	January 7, 2008
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00596037
Health Authority:	United States: Food and Drug Administration

Keywords provided by LG Life Sciences:

Growth hormone Deficiency

Study placed in the following topic categories:

Dwarfism
Bone Diseases, Endocrine
Hypopituitary dwarfism
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases
Central Nervous System Diseases
Dwarfism, Pituitary

Brain Diseases
Bone Diseases
Growth hormone deficiency
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental
Endocrinopathy

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009