Growth Hormone DeficiencyPhase 2/3NCT00600808
Sustained Release Formulation of Somatropin (rDNA Origin)for Injection
A Phase 2/3 study testing BPLG-003 in people with Growth Hormone Deficiency, run by BioPartners GmbH.
Trial summary
Annualised height velocity after 12/24 months treatment and HV SDS height velocity after 12/24 months treatment expressed as number of standard deviations difference from the mean population height velocity for the appropriate gender and chronological age. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- BPLG-003
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Jun 2006
- Phase
- Phase 2/3
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis of GHD as determined by two different GH provocation tests documenting deficient GH secretion, defined as a peak plasma GH level of less than 7 ng/mL and absence of any peak plasma GH level in the spontaneous growth hormone secretion above 7 ng/mL monitored 3 hours before the application of the pharmacological stimuli at least before one stimulation test.
- Pre-pubertal children (boys age: 4-10 years or girls: age 4-9 years) with primary (idiopathic) and secondary (organic) insufficiency of growth hormone secretion.
- Children with negative signs for intracranial tumour or tumour growth as confirmed with Computer tomography (CT) or magnetic resonance imaging (MRI) scan within 12 months prior to inclusion or within 6 months prior to inclusion of children with GH insufficiency occurred after treatment for any brain tumour. Such patients have to be at least 24 months into full clinical remission.
- No prior exposure to rhGH (GH-naïve)
- Height (HT) of at least 2.0 standard deviation (SD) (HT SDS ≤2.0) below the mean height for chronological age (CA) and sex according to the Standards of Prader et al15.
- Height Velocity (HV) of at least -1 SD (HV SDS ≤1) below the mean HV for CA and sex according to the Standards of Prader et al15.
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- Baseline IGF-I level standardized for age and sex less than -1.0 SDS
- Bone age (BA) ≤9 years for boys and ≤ 8 years for girls,
- For children with multiple hormonal deficiencies, stabilized on replacement therapies for other pituitary axes (e.g. thyroid-stimulating hormone, adrenocorticotropic hormone/cortisol and vasopressin) for at least 3 months and 6 months for thyroid replacement therapy prior to enrolment for children with multiple hormonal deficiencies.
- Written informed consent of parent or legal guardian of subject.
Who cannot join
- The result of the 3 hours spontaneous GH peak is equal to, or above 7 ng/ml. The value of the peak GH level in case of repeated pharmacology test is below 7 ng/ml, whilst the 6 hours spontaneous peak GH is above this value,
- Any clinically significant abnormality likely to affect growth or the ability to evaluate growth, such as, but not limited to chronic diseases like renal insufficiency, diabetes mellitus and malnutrition (BMI must be above -2SD and below +2SD of mean BMI for the chronological age and sex, and albumin must be above lower limit of normal (LLN) of the central laboratory for a patient to be included), Chromosomal abnormalities and medical "syndromes", with the exception of holoprosencephaly/septo-optic dysplasia (Turner's syndrome, Laron syndrome, Noonan syndrome or absence of growth hormone receptors).
- Congenital abnormalities (causing skeletal abnormalities), Russell-Silver Syndrome, Skeletal dysplasias, Closed epiphyses,
- Other growth promoting medication such as anabolic steroids, with the exception of pituitary hormone replacement therapy, thyroxine, hydrocortisone and desmopressin (DDAVP) replacement therapies,
- Children requiring glucocorticoid therapy (e.g. asthma) that are on the dose of more than 400 micro gram/day of budesonide or equivalents inhaled for longer than 1 month during a year,
- Poorly controlled pituitary insufficiencies of other axes (e.g., thyroid-stimulating hormone, adrenocorticotropic hormone/cortisol, vasopressin-deficiency), Major medical conditions and/or presence of contraindication to rhGH treatment.
- Known or suspected HIV-positive patient or patient with advanced diseases such as AIDS or tuberculosis, Drug, substance, or alcohol abuse, Known hypersensitivity to the components of study medication, Evidence of tumour growth or malignant disease in remission for less than one year At screening, presence of anti-hGH antibodies
- The patient and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct.
About this study
Official title: A Phase II/IIIa, Assessor Blinded (Partially Blinded), Randomised, Active-Controlled, Multicentre, Parallel-Group Study of the Safety, Efficacy and pk/pd of LB03002 Administered Weekly in Children With Growth Failure Due to GH Deficiency.
Annualised height velocity after 12/24 months treatment and HV SDS height velocity after 12/24 months treatment expressed as number of standard deviations difference from the mean population height velocity for the appropriate gender and chronological age.
Read the detailed description
To evaluate the safety, efficacy and pharmacokinetics/ pharmacodynamics of LB03002 in the treatment of growth failure in children with growth hormone deficiency (GHD) and to determine the dose for a subsequent phase IIIb BPLG-004 study
- Conditions
- Growth Hormone Deficiency
- Being tested
- BPLG-003
- Keywords
- SR-hGH, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPLG-003Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualised HV after 12/24 months treatment and HV SDS height velocity
Measured: 12/24 months
Secondary outcomes (1)
HVSDS, HTG, HTSD, bone maturation (BM), IGF-I, IGFBP-3
Measured: 12/24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startJun 2003
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioPartners GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LG Life Sciences
- Investigators
- Ference Peter, MD, Principal investigator, BUDA Children's Hospital, Budapest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600808
- Sponsor's protocol ID
- BPLG-003
- Status last verified
- Jul 2007
- First submitted
- 23 Jul 2007
- Last updated
- 25 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/IIIa, Assessor Blinded (Partially Blinded), Randomised, Active-Controlled, Multicentre, Parallel-Group Study of the Safety, Efficacy and pk/pd of LB03002 Administered Weekly in Children With Growth Failure Due to GH Deficiency.
- ClinicalTrials.gov ID
- NCT00600808
- Acronym / sponsor ID
- BPLG-003
- Conditions
- Growth Hormone Deficiency
- Keywords
- SR-hGH, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- BioPartners GmbHIndustry (pharma, biotech, devices)
- Collaborators
- LG Life Sciences
- Study start
- Jun 2003
- Study completion
- Jun 2006 (actual)
- First posted
- 25 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.
Annualised height velocity after 12/24 months treatment and HV SDS height velocity after 12/24 months treatment expressed as number of standard deviations difference from the mean population height velocity for the appropriate gender and chronological age.
Detailed description
To evaluate the safety, efficacy and pharmacokinetics/ pharmacodynamics of LB03002 in the treatment of growth failure in children with growth hormone deficiency (GHD) and to determine the dose for a subsequent phase IIIb BPLG-004 study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Confirmed diagnosis of GHD as determined by two different GH provocation tests documenting deficient GH secretion, defined as a peak plasma GH level of less than 7 ng/mL and absence of any peak plasma GH level in the spontaneous growth hormone secretion above 7 ng/mL monitored 3 hours before the application of the pharmacological stimuli at least before one stimulation test.
- Pre-pubertal children (boys age: 4-10 years or girls: age 4-9 years) with primary (idiopathic) and secondary (organic) insufficiency of growth hormone secretion.
- Children with negative signs for intracranial tumour or tumour growth as confirmed with Computer tomography (CT) or magnetic resonance imaging (MRI) scan within 12 months prior to inclusion or within 6 months prior to inclusion of children with GH insufficiency occurred after treatment for any brain tumour. Such patients have to be at least 24 months into full clinical remission.
- No prior exposure to rhGH (GH-naïve)
- Height (HT) of at least 2.0 standard deviation (SD) (HT SDS ≤2.0) below the mean height for chronological age (CA) and sex according to the Standards of Prader et al15.
Key exclusion criteria (8 listed)
- The result of the 3 hours spontaneous GH peak is equal to, or above 7 ng/ml. The value of the peak GH level in case of repeated pharmacology test is below 7 ng/ml, whilst the 6 hours spontaneous peak GH is above this value,
- Any clinically significant abnormality likely to affect growth or the ability to evaluate growth, such as, but not limited to chronic diseases like renal insufficiency, diabetes mellitus and malnutrition (BMI must be above -2SD and below +2SD of mean BMI for the chronological age and sex, and albumin must be above lower limit of normal (LLN) of the central laboratory for a patient to be included), Chromosomal abnormalities and medical "syndromes", with the exception of holoprosencephaly/septo-optic dysplasia (Turner's syndrome, Laron syndrome, Noonan syndrome or absence of growth hormone receptors).
- Congenital abnormalities (causing skeletal abnormalities), Russell-Silver Syndrome, Skeletal dysplasias, Closed epiphyses,
- Other growth promoting medication such as anabolic steroids, with the exception of pituitary hormone replacement therapy, thyroxine, hydrocortisone and desmopressin (DDAVP) replacement therapies,
- Children requiring glucocorticoid therapy (e.g. asthma) that are on the dose of more than 400 micro gram/day of budesonide or equivalents inhaled for longer than 1 month during a year,
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 |
|---|---|---|
| BPLG-003 | Drug | – |
Primary outcome
Annualised HV after 12/24 months treatment and HV SDS height velocity
Time frame: 12/24 months
1 secondary outcome
HVSDS, HTG, HTSD, bone maturation (BM), IGF-I, IGFBP-3
Time frame: 12/24 months
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 25 Jan 2008.
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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.
Ference Peter, MD principal investigator
BUDA Children's Hospital, Budapest
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BPLG-003 in people with Growth Hormone Deficiency, run by BioPartners GmbH.
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 10 inclusion and 8 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 25 Jan 2008. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Annualised HV after 12/24 months treatment and HV SDS height velocity (time frame: 12/24 months). 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 25 Jan 2008.