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Genotonorm Medical Research Studies

Up-to-date List of Genotonorm Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Genotonorm Medical Research Studies

Rank Status Study
1 Recruiting An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Growth Hormone Deficiency (GHD) of Adult Onset
Condition: Growth Hormone Deficiency
Intervention: Drug: Saizen® solution for injection (referred as Saizen®)
Outcome Measures: Percentage of subjects developing Binding Antibodies (BAbs) to Saizen®;   Percentage of subjects with BAbs who become positive for Neutralizing Antibody (NAbs);   Insulin-like growth Factor-I (IGF-I) levels;   Insulin-like growth factor binding Protein-3 (IGFBP-3) levels;   Insulin-like Growth Factor-I Standard Deviation Score (IGF-I SDS) levels;   Treatment adherence rate for each subject as documented using EasypodTM connect;   Number of subjects with treatment-emergent adverse events
2 Unknown  Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency
Condition: Growth Hormone Deficiency
Intervention: Drug: Somatropin
Outcome Measure: Mean change in annualized height velocity from pre-treatment to the first 26 weeks of treatment
3 Recruiting Growth Hormone Use in Albright Hereditary Osteodystrophy
Conditions: Pseudohypoparathyroidism Type 1a;   Albright Hereditary Osteodystrophy
Interventions: Drug: Growth hormone;   Drug: Growth Hormone
Outcome Measure: PHP1a: Effect of GH on height, growth velocity, final height in children. Effect on weight, BMI, lipids, self-esteem in all ages.
4 Recruiting A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency
Conditions: Growth Hormone Disorder;   Growth Hormone Deficiency in Children
Interventions: Drug: NNC0195-0092;   Drug: somatropin
Outcome Measures: Incidence of adverse events (AEs);   The area under the insulin-like growth factor I (IGF-I) concentration-time curve
5 Recruiting Growth Hormone in Poor Responders to IVF Trial
Condition: Infertility
Interventions: Drug: Saizen (Human Growth Hormone);   Drug: No Saizen Control (Standard IVF Protocol)
Outcome Measures: Oocyte yield;   Pregnancy rate
6 Unknown  Effects of Growth Hormone on Glucose and Protein Metabolism in Children With Growth Hormone Deficiency
Condition: Growth Hormone Deficiency
Intervention: Drug: growth hormone (Nutropin)
Outcome Measures: Glucose Production rate,Gluconeogenesis, glycogenolysis.;   Insulin resistance;   Proteolysis;   Glucagon response
7 Recruiting Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?
Conditions: Prader-Willi Syndrome;   Growth Hormone Deficiency
Interventions: Drug: Growth hormone (Genotonorm® or Omnitrope®);   Procedure: DEXA, blood tests, H.G.P.O, osseous age.;   Procedure: biopsy
Outcome Measures: Measure of the circulating rates of IGF-I under treatment.;   Measure of the circulating rate of IGFBP-3, GHBP, ghrelin and apelin.;   Measure of physical composition's variation.;   Measure of blood sugar level, H.G.P.O., and hyperglycaemia.;   Measure of the sensibility at the growth hormone in vitro, on fibroblasts and adipocytes obtained by biopsy.
8 Recruiting Safety, PK/PD and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
Condition: Growth Hormone Deficiency (GHD)
Interventions: Drug: ACP-001;   Drug: Human Growth Hormone
Outcome Measures: Safety of ACP-001 on different dosing levels;   Pharmacokinetics of ACP-001;   IGF-I response;   Local tolerability of ACP-001;   Height velocity
9 Unknown  Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism
Condition: Hypothyroidism
Interventions: Drug: Growth hormone;   Drug: Growth hormone treatment and puberty
Outcome Measures: final height;   bone age;   growth factors
10 Recruiting A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Pediatric Subjects Using SAIZEN® Via Easypod™ Auto-injector for Growth Hormone Treatment
Condition: Growth Disorders
Intervention: Device: Easypod™
Outcome Measures: Mean percent of adherence by subject over a period of time;   Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™;   Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment;   Impact of patient adherence support programme on adherence and outcomes for subjects using easypod™
11 Recruiting A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
Condition: Growth Hormone-Deficiency
Interventions: Drug: TV-1106;   Drug: somatropin
Outcome Measures: Height velocity (HV);   Height velocity standard deviation score (HV-SDS);   Height standard deviation score (H-SDS);   Number of participants with adverse events
12 Recruiting Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis
Condition: Osteoporosis
Interventions: Dietary Supplement: Vitamin D + Calcium + Exercise program;   Drug: Vitamin D + Calcium + Exercise program + Humatrope
Outcome Measures: Test the hypothesis that growth hormone administered daily by subcutaneous injection for 2 years will result in a significantly greater BMD Z-score over optimal standard therapy;   Test the hypothesis that subcutaneous growth hormone administration will significantly improve and/or normalize baseline values of fracture frequency;   Test the hypothesis that subcutaneous growth hormone administration will significantly improve and/or normalize baseline values of bone histomorphometric measures osteoid volume, surface, and width;   Test the hypothesis that subcutaneous growth hormone administration will significantly improve and/or normalize baseline measures of bone quality;   Test the hypothesis that subcutaneous growth hormone administration will significantly improve and/or normalize baseline values of BMC corrected for height
13 Recruiting Metabolic Signalling in Muscle- and Adipose-tissue Following Insulin Withdrawal and Growth Hormone Injection.
Conditions: Diabetes Mellitus Type I;   Ketoacidosis
Interventions: Drug: Insulin withdrawal;   Drug: Norditropin
Outcome Measures: Insulin and growth hormone signalling, expressed as CHANGE in phosphorylation of intracellular target proteins and CHANGE in mRNA expression of target genes in muscle- and fat-tissue.;   Change in Intracellular markers of lipid metabolism in muscle- and fat tissue biopsies.;   Metabolism
14 Recruiting A Prospective Non-Interventional Study Protocol With Primary Data Collection - Assessment Of The Long Term Treatment Outcomes Of Genotropin Treatment In Growth Hormone Deficiency (GHD) Patients
Condition: Growth Hormone Deficiency
Intervention: Other: Non Interventional Study
Outcome Measure: This Non-Interventional study does not include pre-specified endpoints, but collects information from adult subjects recieving Genotropin treatment in a real world clinic setting.
15 Recruiting A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS)
Condition: Idiopathic Short Stature
Intervention: Drug: Saizen®
Outcome Measures: Change from baseline in growth velocity (centimeter/year [cm/yr]) at Month 6;   Change from baseline in growth velocity (cm/yr) at Month 12;   Changes from baseline in height (centimeter [cm]) at Month 6 and 12;   Changes from baseline in height standard deviation score (SDS) at Month 6 and 12;   Changes from baseline in serum concentration of insulin-like growth factor-I (IGF-I) and insulin like growth factor binding protein-3 (IGFBP-3) at Month 6 and 12;   Percentage of participants who adhered to study treatment;   Number of participants with adverse events (AEs)
16 Recruiting Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome
Condition: Turner Syndrome
Intervention: Drug: somatotropin
Outcome Measures: Total brain volume;   Volume of brain lobes;   White matter tracts
17 Unknown  Growth Hormone Treatment of Young Growth Hormone-Deficient Adults
Condition: Growth Hormone Deficiency
Intervention: Drug: Growth hormone
Outcome Measure:
18 Not yet recruiting Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.
Conditions: GH Deficiency (GHD);   Growth Retardation
Intervention: Drug: Somatropin
Outcome Measures: The primary efficacy endpoint will be based in the investigation of pharmacokinetics and pharmacodynamics of somatropin in research subjects after administration of single dose, sc, of the drug.;   After administration of the drug will be evaluated for safety and tolerability of the drug through the presence of hematoma, pain, itching and local redness, as well as the incidence of adverse events directly related to somatropin.
19 Recruiting Growth Hormone and Brain Functioning After Traumatic Brain Injury
Condition: Traumatic Brain Injury
Intervention: Drug: Genotropin (somatropin)
Outcome Measures: To compare the brain-functioning (fMRI & EEG) and white matter structural integrity (DTI) of persons with mild to severe TBI with and without GH deficiency during cognitive tasks.;   To examine changes in cognitive and motor performance, EEG/fMRI, white matter integrity, associated with growth hormone treatment for one year using an open-label design in persons with GH deficiency/insufficiency following mild to severe TBI.
20 Recruiting Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ Electromechanical Device for Growth Hormone Treatment
Condition: Growth Disorders
Intervention: Device: easypod ™
Outcome Measures: Mean percent of daily recorded adherence;   Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™;   Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment;   Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges)

These studies may lead to new treatments and are adding insight into Genotonorm etiology and treatment.

A major focus of Genotonorm research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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