This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).
The purpose of this study is 1. to monitor short children born SGA who were treated with growth hormone in study EP00-401 for the development of diabetes for a further 10 years after termination of growth hormone treatment and 2. to report the incidence of anti-rhGH antibodies and of E. coli host cell peptide (HCP) antibodies (ABs) for 6 months after termination of GH treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
130
Bloodsampling
Novartis Investigative Site
Ústí nad Labem, Czech Republic, Czechia
Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy.
Number of participants diagnosed with Diabetes mellitus type 2 during the study, defined as fullfilment of these 3 criteria: * FPG ≥ 126 mg/dl (7.0 mmol/L) during blood sampling and/or during Oral Glucose Tolerance Test (OGTT) * 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/L) during an OGTT * Investigator documenting diagnosis of diabetes mellitus type 2 during OGTT
Time frame: 5 years
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Plasma Glucose (FPG) Levels
Supportive to Primary Endpoint
Time frame: baseline, 6 months, 1 year, 5 years
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Insulin Levels
Supportive to Primary Endpoint
Time frame: baseline, 6 months, 1 year, 5 years
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Glucose Glycolsylated Hemoglobin (HbA1c)
Supportive to Primary Endpoint
Time frame: baseline, 6 months, 1 year, 5 years
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through HOMA and QUICKI Scores
Supportive to Primary Endpoint. HOMA = homeostasis model assessment for Insulin resistance: Healthy Range: 1.0 (0.5-1.4). \< 1.0 means you are insulin-sensitive which is optimal. \>1.9 indicates early insulin resistance. \> 2.9 indicates significant insulin resistance. The quantitative insulin sensitivity check index (QUICKI) measures insulin sensitivity, which is the inverse of insulin resistance. The QUICKI calculation for insulin resistance in humans fall broadly within a range between 0.45 for unusually healthy individuals and 0.30 in diabetics. Lower numbers reflect greater insulin resistance.
Time frame: baseline, 6 months, 1 year, 5 years
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Novartis Investigative Site
Hradec Králové, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Tbilisi, Georgia
Novartis Investigative Site
Nordrhein Westfalen, Sankt Augustin, Germany
Novartis Investigative Site
München, Germany
Novartis Investigative Site
Miskolc, Hungary
Novartis Investigative Site
Poznai, Greater Poland Voivodeship, Poland
Novartis Investigative Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Novartis Investigative Site
Wroclaw, Lower Silesian Voivodeship, Poland
...and 13 more locations
to Evaluate IGF-I and IGFBP-3 Levels After End of Growth Hormone Treatment
Time frame: baseline, 6 months, 1 year , 5 years
To Evaluate the Incidence of Anti-rhGH Antibodies After Termination of Growth Hormone Treatment.
number of participants with positive results for anti-drug antibody (ADA). Percentages indicated are calculated based on the total number of patients (118 participants).
Time frame: baseline, 6 months, 1 year, 5 years
to Evaluate Final Height
Time frame: baseline, 6 months, 1 year, 5 years