Clinical trials: Growth Hormone Deficiency, Pediatric
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
Pediatric Growth Hormone Deficiency
A Study (Phase 1b/2) of GS3-007a Oral Treatment in Children With Growth Hormone Deficiency (PGHD)
This is a two-part clinical study for children with growth hormone deficiency. In the first part, participants will be randomly assigned to receive different doses of an oral treatment (GS3-007a dry suspension) or a placebo for…
- Trial name
- NCT07264595
- Testing
- GS3-007a dry suspension, rhGH injection
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Growth Hormone Deficiency (GHD)
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
The OraGrowtH Phase 3 Trial is a multi-national trial. The goals of the trial are to study LUM-201 as a treatment for Pediatric Growth Hormone Deficiency (PGHD) in naive to treatment children and validate the LUM-201 predictive…
- Trial name
- NCT06948214
- Testing
- LUM-201
- Where
- 55 sites in United States, Argentina and 6 more
- Volunteers
- 150 people
- Sponsor
- Lumos Pharma
Pediatric Growth Hormone Deficiency (PGHD)
A Clinical Trail to Compare Pharmacokinetics of Two PEG-rhGH Injections With Different Preparations
The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.
- Trial name
- NCT06135168
- Testing
- PEG-rhGH with new preparation, PEG-rhGH with present preparation
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Pediatric Growth Hormone Deficiency
Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
This is an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.
- Trial name
- NCT02968004
- Testing
- MOD-4023, Somatropin
- Where
- 81 sites in United States, Argentina and 18 more
- Volunteers
- 224 people
- Sponsor
- OPKO Health, Inc.
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 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.
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.
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
Korean Post-marketing Surveillance Ngenla® Pre-filled Pen Injection for the Treatment of Pediatric Patients With Growth Disturbance Due to Insufficient Secretion of Growth Hormone
This non-interventional study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Ngenla® pre-filled pen injection, which is required…
- Trial name
- NCT05509894
- Testing
- Ngenla
- Where
- South Korea
- Volunteers
- 565 people
- Sponsor
- Pfizer
Growth Hormone Deficiency, Pediatric, Endocrine System Diseases
A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial
A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial.
- Conditions
- Growth Hormone Deficiency, Pediatric, Endocrine System Diseases, Hormone Deficiency, Pituitary Diseases
- Trial name
- enliGHten (NCT03344458)
- Testing
- TransCon hGH
- Where
- 42 sites in United States, Armenia and 9 more
- Volunteers
- 298 people
- Sponsor
- Ascendis Pharma A/S
Pediatric Growth Hormone Deficiency (PGHD)
A Bioequivalence Study of Two Different Processes of 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
- NCT06840691
- Testing
- PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (T)
- 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
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.
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, 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 (PGHD)
A Bioavailability Study of Two Different PEG-rhGH Preparations.
The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations.
- Trial name
- NCT06385145
- Testing
- PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R)
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Growth Hormone Deficiency
Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method
The purpose of this study is to obtain psychological response and user preference information on the use of the T jet® device versus the traditional subcutaneous injection administration of Tev Tropin®.
- Trial name
- T-jet® (NCT00990340)
- Testing
- T-jet® containing TevTropin®, TevTropin® needle-syringe injection method
- Volunteers
- 52 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Pediatric Growth Hormone Deficiency
Versartis Trial in Children to Assess Long-Acting Growth Hormone
This is a Phase 1b/2a study of VRS-317 (long-acting growth hormone) in pediatric patients with growth hormone deficiency. During Phase 1b, pediatric patients each will receive a single subcutaneous injection of VRS-317.
- Trial name
- VERTICAL (NCT01718041)
- Testing
- Experimental: VRS-317
- Where
- 23 sites in United States
- Volunteers
- 64 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.