Clinical trials: Growth Hormone Deficiency, Pediatric
Craniocerebral Trauma, Hypothalamic-pituitary Disorders
Long-term Follow-up of Pituitary and Hypothalamic Dysfunction in Children Who Have Suffered Moderate to Severe Head Trauma Included in the ENDOC TC Cohort
The annual incidence of traumatic brain injury (TBI), all causes combined, varies between 180 and 300 per 100,000. TBI increases the risk of death or serious sequelae by a factor of 8.
- Conditions
- Craniocerebral Trauma, Hypothalamic-pituitary Disorders, Pediatric, Endocrinology
- Trial name
- ENDOC TC 2 (NCT07533435)
- Testing
- Telephone questionnaire
- Where
- France
- Volunteers
- 90 people
- Sponsor
- Hospices Civils de Lyon
Dwarfism, Pituitary
A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.
The purpose of this study is to learn about the safety of Somatrogon for the treatment of pediatric growth hormone deficiency (p GHD) in India.
- Trial name
- NCT06587035
- Testing
- Somatrogon
- Where
- 4 sites in India
- Volunteers
- 50 people
- Sponsor
- Pfizer
Growth Hormone Deficiency in Children, Growth Hormone Deficiency (GHD)
Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency
This study aims to evaluate the efficacy and safety of GB08 injection compared to Norditropin NordiFlex in pediatric patients with growth hormone deficiency (PGHD).
- Conditions
- Growth Hormone Deficiency in Children, Growth Hormone Deficiency (GHD), Growth Hormone
- Trial name
- NCT07126288
- Testing
- GB08, Norditropin NordiFlex
- Where
- 16 sites in China
- Volunteers
- 268 people
- Sponsor
- Shenzhen Kexing Pharmaceutical Co., Ltd.
Growth Disorders
Long-Acting Growth Hormone in Children Compared to Daily rhGH
The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of treatment effect against daily injections of rhGH.
- Trial name
- VELOCITY (NCT02339090)
- Testing
- Somavaratan, rhGH
- Volunteers
- 138 people
- Sponsor
- Versartis Inc.
Growth Hormone Deficiency, Pediatric, Endocrine System Diseases
A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency
A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (GHD) will be included.
- Conditions
- Growth Hormone Deficiency, Pediatric, Endocrine System Diseases, Hormone Deficiency, Pituitary Diseases
- Trial name
- NCT03305016
- Testing
- TransCon hGH
- Where
- 24 sites in United States, Australia and 2 more
- Volunteers
- 146 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Pediatric Growth Hormone Deficiency
Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
This is a phase II, open label, active-controlled, randomized safety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone deficient children.
- Trial name
- NCT01592500
- Testing
- MOD-4023, Somatropin
- Where
- 4 sites in Greece, Hungary and 1 more
- Volunteers
- 56 people
- Sponsor
- OPKO Health, Inc.
Growth Hormone Deficiency
A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency
This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first…
- Trial name
- NCT00314938
- Testing
- PHA-794428
- Where
- 7 sites in Belgium, France and 3 more
- Volunteers
- 32 people
- Sponsor
- Pfizer
Growth Hormone Deficiency (GHD)
Development of a Personalized Growth Hormone Treatment Profile (PGTP) Report for Pediatric Endocrinology
The goal of this observational study is to learn how to make growth hormone treatment more personalized for children. The main questions it aims to answer are: How can information about treatment adherence and patient experiences…
- Trial name
- PGTP (NCT06830525)
- Testing
- ACDP® and growth hormone treatment
- Where
- Spain
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Luis Fernandez Luque
Pediatric Growth Hormone Deficiency, Growth Disorders
Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317)
The trial will consist of three stages: 1) a 30 day Phase 2 PK and PD evaluation of somavaratan, 2) an optional Phase 2 Extension and 3) a 12 month Phase 3 safety and efficacy stage.
- Trial name
- NCT02413138
- Testing
- Somavaratan (VRS-317)
- Where
- Japan
- Volunteers
- 41 people
- Sponsor
- Versartis Inc.
Pediatric Growth Hormone Deficiency (PGHD)
A Bioequivalence Study of Two Different PEG-rhGH Preparations.
The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
- Trial name
- NCT06331026
- Testing
- PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R)
- Where
- China
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Growth Hormone Deficiency
A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is
This research study will find out if a new growth hormone stimulation test is safe and works as well as other tests to diagnose growth hormone deficiency (GHD) in children.
- Trial name
- DETECT (NCT04786873)
- Testing
- Macimorelin, Arginine, Clonidine
- Where
- 45 sites in United States, Armenia and 9 more
- Volunteers
- 101 people
- Sponsor
- AEterna Zentaris
Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone)
A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily.
- Conditions
- Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone), Endocrine System Diseases, Hormones
- Trial name
- NCT02781727
- Testing
- Once weekly subcutaneous injection of TransCon hGH, Once daily subcutaneous injection of Genotropin
- Where
- 53 sites in United States, Armenia and 12 more
- Volunteers
- 162 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Growth Hormone Deficiency, Endocrine System Diseases
Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency
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)…
- Conditions
- Growth Hormone Deficiency, Endocrine System Diseases, Hormones, Pituitary Diseases
- Trial name
- NCT04326374
- Testing
- TransCon hGH, daily hGH
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Visen Pharmaceuticals (Shanghai) Co., Ltd.
Growth Hormone Deficiency
PK and PD Study of LUM-201 in Children With Idiopathic Growth Hormone Deficiency: (OraGrowtH212)
The goals of this single site trial are to study the pharmacokinetics (PK) and pharmacodynamics of LUM-201 and effects of LUM-201 administration on growth hormone release over time in children with idiopathic pediatric growth…
- Trial name
- OraGrowtH212 (NCT04806854)
- Testing
- LUM-201
- Where
- Chile
- Volunteers
- 24 people
- Sponsor
- Lumos Pharma
Growth Hormone Deficiency
Evaluation of the Propensity of Patients Under rhGH to Envision a Modification of Their Treatment Regimen Toward LAGH
Daily subcutaneous injections of rhGH can be burdensome for patients, leading to poor adherence and reduced growth outcomes. This has spurred the development of long-acting GH (LAGH) analogues that allow for weekly, biweekly, or…
- Trial name
- TOWARD-LAGH (NCT06542809)
- Testing
- Questionnaire
- Where
- Belgium
- Volunteers
- 500 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Pediatric Growth Hormone Deficiency
Versartis Long-Term Safety Study of Somavaratan
Protocol 13VR3 is is a multi-center, open-label study assessing long-term somavaratan administration. Patients will be monitored for safety throughout their participation in the study.
- Trial name
- VISTA (NCT02068521)
- Testing
- somavaratan
- Volunteers
- 385 people
- Sponsor
- Versartis Inc.
Pediatric Growth Hormone Deficiency
A Study of GenSci134 in Children With Growth Hormone Deficiency (PGHD)
This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation to assess safety, tolerability, PK/PD profile, and immunogenicity of…
- Trial name
- NCT07450001
- Testing
- GenSci134 Injection, Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.