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Growth Hormone Deficiency clinical trials

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NCT ID: NCT06455956 Recruiting - Clinical trials for Growth Hormone Deficiency

Use of miRNAs in Growth Hormone Deficiency (GHD)

GH-miRNA2
Start date: April 13, 2023
Phase:
Study type: Observational

This study aims at improving knowledge about the diagnosis of growth hormone deficiency (GHD) and treatment with growth hormone (GH), with the goal of providing information on the presence of new biomarkers, such as miRNAs, for diagnostic and therapeutic purposes, with the goal of establishing a personalized GH treatment scheme, optimizing resources, reducing costs, and improving outcomes.

NCT ID: NCT06294860 Recruiting - Clinical trials for Growth Hormone Deficiency

Biological Age in Children With GH Deficiency Undergoing Hormone Replacement Therapy

ETABIOGHD
Start date: June 19, 2023
Phase:
Study type: Observational

The primary objective of the study is to evaluate the epigenetic age in children with GH deficiency, before and after 6 months of treatment with growth hormone replacement therapy. The secondary objective is to correlate the epigenetic age with the auxometric and biochemical parameters used in the clinical-endocrinological practice. The results of the study will be useful to set up the clinical and biochemical follow-up of the hormone replacement therapy with rhGH and to understand the biomolecular mechanisms at the base of the debated "anti" or "pro" aging action of GH, the most important anabolic hormone of the human organism.

NCT ID: NCT05820672 Recruiting - Clinical trials for Growth Hormone Deficiency

A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA

SkybriGHt
Start date: March 20, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care

NCT ID: NCT05775523 Recruiting - Clinical trials for Growth Hormone Deficiency

A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

SkyPASS
Start date: March 20, 2023
Phase:
Study type: Observational

The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.

NCT ID: NCT05681299 Recruiting - Healthy Clinical Trials

Effects of GH and Lirglutide on AgRP

Start date: May 1, 2023
Phase: Phase 4
Study type: Interventional

This is a randomized, placebo-controlled, cross-over study with 4 arms. Healthy and GH deficient adults ages 18-45 years will be studied. Arms will consist of 21-day treatment periods and be separated by 8-week washout periods. Subjects will receive, in random order: i) GH alone, ii) GH with liraglutide, iii) liraglutide alone and iv) placebo. Each phase of the study will consist of a 7-day baseline period including 2 days of testing and 21 days on therapy with visits on days 2, 7, 14 and 21. Testing before, during and at the completion of each arm will include blood sampling and assessments of insulin resistance, energy expenditure and body composition.

NCT ID: NCT05603936 Recruiting - Clinical trials for Growth Hormone Deficiency

Adaption and Testing of the Quality of Life in Short Stature Youth (QoLISSY) Questionnaire for Parents With Children From 0-4

Start date: March 1, 2022
Phase:
Study type: Observational

The aim of the study is the adaption, implementation and validation of the instrument for the investigation of the short stature specific quality of life (QoLISSY) for children (age 0-4 years) with achondroplasia (ACH), Small for Gestational Age (SGA) and Growth Hormone Deficiency (GHD) from a parental perspective.

NCT ID: NCT04938466 Recruiting - Clinical trials for Growth Hormone Deficiency

Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy

LAuGH TRACK
Start date: August 5, 2021
Phase:
Study type: Observational

The purpose of the study is to compare quality of life, adherence, insulin resistance, body composition and efficacy of long-acting growth hormone (LAGH) to daily growth hormone (DGH) in children with growth hormone deficiency (GHD). These objectives will be evaluated every 6 months for subjects prior to switch from DGH to LAGH, and 6 months after.

NCT ID: NCT04798690 Recruiting - Clinical trials for Growth Hormone Deficiency

Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature

Start date: February 8, 2021
Phase:
Study type: Observational [Patient Registry]

This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.

NCT ID: NCT04352712 Recruiting - Clinical trials for Growth Hormone Deficiency

Gene Expression in Monocytes of Growth Hormone Deficient Children

GEMGH
Start date: April 15, 2019
Phase:
Study type: Observational

The Growth hormone (GH) is mainly synthesized in the anterior portion of the pituitary gland and has an effect on different body areas. Secreted in the circulatory stream, growth hormone reaches the liver and here stimulates the secretion of somatomedin C better known as insulin-like growth factor 1 (IGF), which constitutes its main anabolic effector. Growth hormone deficiency (GHD) is characterized by a delay in the statural growth in children and is correlated with a worsening of body composition, cognitive functions, lipid metabolism, bone mineralization, cardiac performance and exercise in adults. Recombinant GH (rhGH) replacement therapy can correct these alterations and therefore improve the quality of life in treated patients, and accelerate growth in children. The optimal dosage of rhGH varies for each patient, as the response to treatment suffers from considerable inter-individual variability. To date, IGF1 is the only available biomarker whose plasma levels correlate with replacement therapy. It is important to underline how somatomedin C does not provide information about the optimal posology of rhGH for each patient in order, therefore, to predict its adverse events and efficacy. In addition, it has been shown that the effects mediated by the somatotropic hormone on some tissues are direct, therefore independent of the action of IGF1, whose plasma levels are not, in this case, predictive of therapeutic response. For this reason, it is therefore necessary to identify a more specific biomarker capable of monitoring the efficacy, individual responsiveness and any adverse events in patients receiving somatotropic hormone. The GH receptor (GHR) is expressed in several cells, including monocytes. It is therefore possible that the response of monocytes to the somatotropic hormone partially mirrors that of the chondrocyte and other cell types. Given the difficulty of obtaining osteomuscular biopsies or specific body areas in which GH mediates its biological action, the published works have identified the specific cell line in which to study the molecular effects of the hormone in monocytes, thanks to their easy accessibility and high number of GHR. In consideration of this, the investigators propose to stimulate monocytes of healthy and GHD children in vitro with rhGH and through next generation sequencing to identify the characteristic gene expression profile. The GH responsive genes identified with this study can be used for correlation studies on the response to rhGH treatment.

NCT ID: NCT04326374 Recruiting - Clinical trials for Growth Hormone Deficiency

Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency

Start date: December 30, 2019
Phase: Phase 3
Study type: Interventional

This study is conducted in China only. The purpose is to demonstrate the efficacy and safety of once weekly dosing of TransCon hGH, a long-acting growth hormone product, compare to once-daily dosing of human growth hormone (hGH) after 52 weeks of treatment in prepubertal children with growth hormone deficiency (GHD).