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Dwarfism, Pituitary clinical trials

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NCT ID: NCT06109935 Recruiting - Clinical trials for Growth Hormone Deficiency in Children

Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed

Start date: October 4, 2023
Phase:
Study type: Observational

The purpose of the study is to investigate the safety and effectiveness of Sogroya® in children with short stature due to growth hormone deficiency where epiphysial discs are not closed under real-world clinical practice in Japan. The study will last for about 1 year (at shortest) to 3 years (at longest) depending on when the participant takes part in the study. The participant will be asked to answer questionnaire(s) about how they feel about the growth hormone (GH) product treatment once during the study (at about 3 months after starting the Sogroya® treatment) and about 3 months after starting the Sogroya® treatment.

NCT ID: NCT05759624 Recruiting - GH Deficiency Clinical Trials

Vesiculogenesis in Children With GH Deficiency (VESCIGHTP)

VESCIGHTP
Start date: June 24, 2022
Phase:
Study type: Observational

The primary objective of the study is to evaluate the size and derivational profile of the extracellular vescicles (EV) generated in children with GH deficiency, undergoing hormone replacement therapy with rhGH. Secondary objectives is to correlate vesiculogenesis with auxometric and biochemical parameters used in clinical-endocrine practice in the evaluation of short stature. The results of the study will provide useful information to more rationally set up the clinical and biochemical follow-up of hormone replacement therapy with rhGH, as well as to understand the molecular and cellular mechanisms underlying the multi-systemic action of GH, the most important anabolic hormone of the human organism.

NCT ID: NCT05355272 Recruiting - Clinical trials for Adult Growth Hormone Deficiency

Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)

GWIT
Start date: February 12, 2024
Phase: Phase 2
Study type: Interventional

The goal of the GWIT Study is to assess whether growth hormone replacement therapy is a safe and effective treatment for veterans with Gulf War Illness (GWI) and adult growth hormone deficiency (AGHD). The main questions the study aims to answer are: 1. Is growth hormone effective at reducing fat in the trunk of the body and symptoms of GWI among veterans with GWI and growth hormone deficiency? 2. Do the results of the study suggest there is merit in pursuing a larger trial to examine the efficacy of growth hormone as a treatment for growth hormone deficiency among veterans with Gulf War Illness? To determine eligibility for the study, veterans will be asked to complete several assessments including questionnaires, blood tests, and a scan of the brain. Participants who qualify for the study will receive recombinant human growth hormone for 6-months. A body composition scan will be performed at Day1, Day 90, and Day 180 of the intervention. Questionnaires and cognitive tests will also be collected before and after the trial.

NCT ID: NCT04569149 Recruiting - Clinical trials for Meier-Gorlin Syndrome

Primordial Dwarfism Registry

Start date: March 11, 2008
Phase:
Study type: Observational [Patient Registry]

The goal of this registry is to collect information on individuals with Microcephalic Osteodysplastic Primordial Dwarfism Type II (also called MOPDII) and other forms of microcephalic primordial dwarfism. The study team hopes to learn more about these conditions and improve the care of people with it by establishing this registry.

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).

NCT ID: NCT04121780 Recruiting - Clinical trials for Growth Hormone Deficiency

Growth Hormone Replacement Therapy for Retried Professional Football Players

Start date: October 8, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).

NCT ID: NCT03290235 Recruiting - Growth Retardation Clinical Trials

Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children

Start date: March 1, 2017
Phase: Phase 4
Study type: Interventional

1. To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of children with growth hormone deficiency for a relatively long period 2. To explore the factors influencing the efficacy of PEG-Somatropin and to establish the height prediction model based on Chinese children with short stature, and to provide the basis and guidance for standard and reasonable long-term clinical application of PEG-Somatropin.

NCT ID: NCT03249480 Recruiting - Clinical trials for Growth Hormone Deficiency

Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency

Start date: January 2015
Phase: Phase 4
Study type: Interventional

To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with growth hormone deficiency, as well as to study the dosage of PEG Somatropin.

NCT ID: NCT03104010 Recruiting - Clinical trials for Adult Growth Hormone Deficiency

A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD

Start date: April 2017
Phase: Phase 2
Study type: Interventional

This study aims to explore the optimal dose of PEG-rhGH injection in the treatment of AGHD, preliminarily evaluate its safety and efficacy, to provide scientific and reliable evidence for the medication dosage in Phase 2 clinical study.

NCT ID: NCT03053687 Recruiting - Growth Retardation Clinical Trials

Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of Therapy

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

The Proposed study is a double blind, randomized, placebo controlled study The aim of the study is to evaluate the effect of combined Growth Hormone (GH) treatment & nutritional formula supplementation versus GH & placebo on growth parameters in 64 children with Isolated Growth Hormone Deficiency (IGHD) after the 2nd year of GH treatment. In this trial GH is a background treatment (non-investigational medicinal product. Participants may be treated with any of the commercial GH products approved in Israel for the indication of IGHD. Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1. Both participants and study team will be blinded to the type of treatment that each patient will receive during the study. The randomization will be done according to gender and tanner stage. Participants in the intervention groups will be treated with the study formulas and participants in the control group will be treated with a placebo low caloric formulas (Powder added to water) The study will continue for 6 months of intervention versus active placebo, with additional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the active study supplement.