Clinical trials: Pediatric Growth Hormone Deficiency
Growth Hormone Deficiency
Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)
This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects…
- Trial name
- OraGrowtH210 (NCT04614337)
- Testing
- LUM-201, rhGH Norditropin® pen (34 µg/kg)
- Where
- 43 sites in United States, Australia and 4 more
- Volunteers
- 104 people
- Sponsor
- Lumos Pharma
Pediatric Growth Hormone Deficiency
A Study to Compare the Experiences of Taking Daily Growth Hormone Injections to Weekly Ngenla in Children With Low Levels of Growth Hormone
The purpose of this study is to learn about: how children stick to taking their injections their experience with the study medicines (Ngenla and daily growth hormone) prescribed to children with low levels of growth hormone.
- Trial name
- NCT06113952
- Testing
- Sharps bin to collect used needles/injections
- Sponsor
- Pfizer
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
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.
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
Pediatric Growth Hormone Deficiency
A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency
A Phase III, Randomized, open-label, positive-drug parallel control, Study to Evaluate the Efficacy and Safety of TJ101 in Child subject with growth hormone deficieney.
- Trial name
- NCT04633057
- Testing
- TJ101, NordiFlex
- Where
- 30 sites in China
- Volunteers
- 168 people
- Sponsor
- TJ Biopharma Co., Ltd.
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.
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.
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
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
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
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, 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
Failure to Thrive
Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepubertal patients with SHOX…
- Trial name
- NCT00190658
- Testing
- Somatropin (rDNA origin) for injection
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Eli Lilly and Company
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
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, 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
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.
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
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