Clinical trials: Growth Hormone Deficiency, Pediatric
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 Hormone Deficiency (GHD), Growth Hormone Deficiency in Children
GB06 Phase III Trial for Pediatric Growth Hormone Deficiency
This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children.
- Conditions
- Growth Hormone Deficiency (GHD), Growth Hormone Deficiency in Children, Growth Hormone Deficiency, Pediatric
- Trial name
- NCT07553351
- Testing
- GB06, Norditropin®FlexProTM
- Where
- China
- Volunteers
- 192 people
- Sponsor
- Kexing Biopharm Co., Ltd.
Growth Hormone Deficiency
Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.
- Trial name
- CHOOSE (NCT01112865)
- Testing
- Genotropin Pen, MARK VII pen
- Where
- 23 sites in Czechia, Germany and 5 more
- Volunteers
- 120 people
- Sponsor
- Pfizer
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
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, 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 (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
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 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
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
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
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.
Craniopharyngioma, Growth Hormone Deficiency (GHD)
Hypothalamic-Stratified Nursing Pathway for Pediatric Craniopharyngioma
The goal of this multicenter retrospective cohort study is to determine whether MRI-graded hypothalamic injury severity predicts growth-hormone deficiency (GHD) and neuropsychological morbidity in 500 children and adolescents (≤…
- Trial name
- NCT07342686
- Where
- China
- Volunteers
- 500 people
- Sponsor
- West China Hospital
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
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
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.
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
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
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.