- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00600808
Sustained Release Formulation of Somatropin (rDNA Origin)for Injection
January 15, 2008 updated by: BioPartners GmbH
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Annualised HV after 12/24 months treatment and HV SDS height velocity
Time Frame: 12/24 months
|
12/24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HVSDS, HTG, HTSD, bone maturation (BM), IGF-I, IGFBP-3
Time Frame: 12/24 months
|
12/24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ference Peter, MD, BUDA Children's Hospital, Budapest
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
July 23, 2007
First Submitted That Met QC Criteria
January 15, 2008
First Posted (Estimate)
January 25, 2008
Study Record Updates
Last Update Posted (Estimate)
January 25, 2008
Last Update Submitted That Met QC Criteria
January 15, 2008
Last Verified
July 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- BPLG-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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