Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later MedDRA version: 14.1 Level: LLT Classification code 10018747 Term: Growth hormone System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Omnitrope®
Product Name: Omnitrope
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629015
Concentration unit: mg/ml millig
Sponsors
Sandoz GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pre-pubertal (Tanner stage I) children born SGA • Boys: equal or above 4 years of age (bilateral testicular volume =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Onset of puberty 2. Closed epiphyses 3. Diabetes mellitus type I or type II 4. Fasting blood glucose equal or above 100 mg/dl (5.6 mmol/l) measured in venous blood sample 5. Abnormal findings in OGTT defined by equal or above 140 mg/dl (7.8 mmol/l) after 120 minutes 6. Known IGF-I level above +2SD for sex and age 7. 8. Acute critical illness e.g. suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure. 9. Known to be hepatitis B or hepatitis C positive or HIV-positive, known to have advanced diseases such as AIDS or tuberculosis 10. Any other disease, genetic disorder or malformation or treatment known to be associated with growth retardation, e.g. Turner or Noonan syndrome, Laron syndrome, Russell-Silver syndrome, Prader-Willi syndrome, skeletal dysplasias, chronic renal failure, cystic fibrosis, heart and liver diseases, malabsorption (coeliac disease), malnutrition, patients receiving radiation therapy of head or spinal cord 11. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin 12. Known or suspected hypersensitivity to rhGH or any of the excipients (e.g. benzyl alcohol) 13. Previous treatment with any hGH preparation 14. Oral, inhalative or parenteral treatment with glucosteroids, except for physiological replacement, or hypothyroidism which has been left untreated, or was inadequately treated, or treated for less than 3 months 15. Treatment with LHRH / gonadotropin releasing hormone (GnRH) analoga (e.g. triptorelin) 16. Treatment with antidiabetic medication (e.g. metformin, insulin) 17. Drug abuse, substance abuse, or alcohol abuse 18. Known to be immunocompromised 19. Intake of growth promoting medication, e.g. anabolic steroids 20. Use of other investigational drugs within 30 days of enrolment 21. Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluation of the long-term effect of growth hormone treatment on the development of diabetes during the treatment period in short children born SGA;Secondary Objective: • report the incidence of anti-rhGH antibodies during treatment • evaluation of the efficacy (with respect to changes in height parameters) of Omnitrope® treatment in short children born SGA • evaluation of IGF-I and IGFBP-3 levels during treatment • evaluation of incidence and severity of adverse events ;Primary end point(s): Safety endpoints: - Carbohydrate metabolism: Fasting plasma glucose and insulin levels will be measured at baseline, at 6 and 12 months, then annually during Omnitrope® treatment, and at the end of treatment. Glycosylated haemoglobin (HbA1C) will be measured at baseline, at 6 and 12 months and then annually during Omnitrope® treatment, and at the end of treatment. An oral glucose tolerance test (OGTT) will be performed at baseline, at 6 and 12 months and then annually during Omnitrope® treatment, and at the end of treatment. - Immunogenicity Anti-rhGH antibodies and E. coli host cell peptide (HCP) antibodies will be measured at baseline, at 3, 6, 9, 12, 18 and 24 months, then annually during Omnitrope® treatment, and at the end of treatment. - Safety lab / urine analysis Hematology, blood chemistry and urine analysis will be measured at baseline, at 6 and 12 months, then annually during Omnitrope® treatment, and at the end of treatment. - (Serious) Adverse events: Adverse events will be collected throughout the study. - Vital signs / weight: Vital signs (blood pressure, pulse) as well as weight and pubertal status will be examined at each visit. BMI will be calculated at each visit. Efficacy endpoints: - Auxological: Height, height SDS, height velocity and height velocity SDS will be monitored at baseline, at every 3 months during Omnitrope® treatment and at the end of treatment. - Pharmacodynamic: IGF-I and IGFBP-3 serum levels will be assessed at | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Poland
Contacts
Public ContactDr Werner Englisch
Sandoz Biopharmaceuticals
Outcome results
None listed