Sustained Release Formulation of Somatropin (rDNA Origin)for Injection
Sustained Release Formulation of Somatropin (rDNA Origin)for Injection
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.
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
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.