Treatment of Adults With Growth Hormone Deficiency

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pituitary Disorders Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

23 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Growth hormone - LB03002

Drug

Primary outcomes

Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Collaborators

BioPartners GmbH

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2009
First posted: Jan 16, 2008
Registry last updated: Oct 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed