Treatment of Adults With Growth Hormone Deficiency
A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency
1 other identifier
interventional
136
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2006
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 7, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedOctober 5, 2012
October 1, 2012
2.1 years
January 7, 2008
October 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005
1 year
Study Arms (2)
LB03002 throughout
EXPERIMENTALadministered LB03002 for preceding 26 weeks
Switched to LB03002
EXPERIMENTALadministered placebo for preceding 26 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Life Scienceslead
- BioPartners GmbHcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
HJ Ji, PhD
LG Life Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2008
First Posted
January 16, 2008
Study Start
August 1, 2006
Primary Completion
September 1, 2008
Study Completion
May 1, 2009
Last Updated
October 5, 2012
Record last verified: 2012-10