pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion Level: LLT Classification code 10056438
Conditions
Sponsors
BioPartners GmbH
LG Life Science Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Pre-pubertal children (boys age: > 3 and 3 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? 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, spinal cord irradiation, 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) ? Patients with overt diabetes mellitus (Fasting blood sugar >126 mg/dl) and impaired fasting sugar (Fasting blood sugar >100 mg/dl after repeated blood analysis) ? Chromosomal abnormalities and medical "syndromes" (Turner's syndrome, Laron syndrome, Noonan syndrome or absence of growth hormone receptors), with the exception of septo-optic dysplasia ? 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 µg/d of inhaled budesonide or equivalents inhaled for longer than 1 month during a calendar year ? Bone age (BA) higher than chronological age ? Poorly controlled or uncontrolled pituitary insufficiencies of other axes (e.g., thyroid-stimulating hormone, adrenocorticotropic hormone/cortisol, vasopressin deficiency): Children who are on stable replacement therapy for less than 6 months for thyroid replacement therapy, and less than 3 months for other hormonal deficiencies prior to enrolment ? 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 ? Presence of anti-hGH antibodies at screening ? The patient and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate that the LB03002 is clinically comparable to daily Genotropin® in terms of its safety and efficacy features.;Secondary Objective: none.;Primary end point(s): The primary efficacy endpoint is the height velocity (HV) at the end of 12 months treatment. The HV developed by patients treated with LB03002 will be compared to the control arm receiving daily dose of Genotropin® 0.03 mg/kg/day using non-inferiority tests. Safety endpoints are: ? Incidence of adverse events after 1, 3, 6, 9, 12 months of treatment; ? Incidence of anti-hGH antibody formation after 1, 3, 6, 9, 12 months treatment; ? Incidence of anti-S. cerevisiae protein antibody formation after 1, 3, 6 and 12 months treatment; ? Global tolerability assessment (investigator and patient) ? Investigator's local tolerability assessment; ? Subject's local tolerability assessment; ? IGF-I levels after 1, 3, 6, 9, 12 months treatment; ? IGFBP-3 levels after 1, 3, 6, 9, 12 months treatment; ? Difference of IGF-I SDS and IGFBP-3 SDS after 1, 3, 6, 9, 12 months treatment; ? Blood glucose, fasting insulin level, HbA1c, thyroid panel tests, lipid panel tests, cortisol levels after 1, 3, 6, 9, 12 months treatment; ? All other haematology and biochemical parameters after 3, 6, 9, 12 months treatment; ? Physical examination after 1, 3, 6, 9, 12 months treatment; ? Vital signs after 1, 3, 6, 9, 12 months treatment; | — |
Countries
Austria, Czech Republic, Estonia, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Sweden
Outcome results
None listed