Pituitary DisordersPhase 3NCT00596037
Treatment of Adults With Growth Hormone Deficiency
A Phase 3 study testing Growth hormone - LB03002 in people with Pituitary Disorders and Adult Growth Hormone Deficiency, run by LG Life Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 70 years
- Conditions the study is for
- Pituitary Disorders, Adult Growth Hormone Deficiency
- What is being tested?
- Growth hormone - LB03002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to May 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this 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
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.
- Being tested
- Growth hormone - LB03002
- Keywords
- Growth hormone Deficiency
- Medical subject headings
- Pituitary Diseases, Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormone - LB03002Drug
| Study group | Role | What they receive |
|---|---|---|
| LB03002 throughout | Experimental | administered LB03002 for preceding 26 weeks Receives: Drug: Growth hormone - LB03002 |
| Switched to LB03002 | Experimental | administered placebo for preceding 26 weeks Receives: Drug: Growth hormone - LB03002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startAug 2006
- Primary completionSep 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioPartners GmbH
- Responsible party
- Sponsor
- Investigators
- HJ Ji, PhD, Study chair, LG Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596037
- Sponsor's protocol ID
- BPLG-005-RO
- Status last verified
- Oct 2012
- First submitted
- 7 Jan 2008
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00596037
- Acronym / sponsor ID
- BPLG-005-RO
- Keywords
- Growth hormone Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- BioPartners GmbH
- Study start
- Aug 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LB03002 throughout | Experimental | Drug: Growth hormone - LB03002administered LB03002 for preceding 26 weeks |
| Switched to LB03002 | Experimental | Drug: Growth hormone - LB03002administered placebo for preceding 26 weeks |
Who may qualify
- Ages
- 23 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth hormone - LB03002 | Drug | LB03002 throughout, Switched to LB03002 |
Primary outcome
Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HJ Ji, PhD study chair
LG Life Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Growth hormone - LB03002 in people with Pituitary Disorders and Adult Growth Hormone Deficiency, run by LG Life Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.