Clinical trials: Growth Hormone Deficiency in Children
Osteogenesis Imperfecta
Growth Hormone Therapy in Osteogenesis Imperfecta
Growth deficiency is a key feature of severe Osteogenesis Imperfecta (OI) and a frequent feature of mild to moderate forms of the disease. The reason that children with OI are short is not fully understood.
- Trial name
- NCT00001305
- Testing
- Humatrope
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Growth Hormone Deficiency
Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency
Multi-center, randomized, controlled, open-label, phase III study comparing the effects of two different dosages of somatropin treatment (in-label or doubled) after 12 and 24 months of treatment, on height velocity in early…
- Trial name
- NCT00191165
- Testing
- Somatropin
- Where
- 10 sites in Italy
- Volunteers
- 27 people
- Sponsor
- Eli Lilly and Company
Growth Hormone Deficiency in Children
A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)
The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe).
- Trial name
- REAL4 (NCT03811535)
- Testing
- Somapacitan, Norditropin®
- Where
- 139 sites in United States, Algeria and 24 more
- Volunteers
- 200 people
- Sponsor
- Novo Nordisk A/S
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 Hormone Deficiency
Phase 2 Study of LUM-201 in Children Who Have Previously Completed the LUM-201-01 Trial (OraGrowtH213)
This is a multi-national trial. The goals of the trial are to study the growth response to LUM-201 administration in children with idiopathic growth hormone deficiency (GHD) previously treated with daily rhGH for 12 months in the…
- Trial name
- OraGrowtH213 (NCT05250063)
- Testing
- LUM-201
- Where
- 10 sites in United States, Poland
- Volunteers
- 15 people
- Sponsor
- Lumos Pharma
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.
Dwarfism, Pituitary
Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®
This is an open-label, prospective, multicentric, non-comparative, non-randomized Phase IV interventional study in which subjects pre-diagnosed with Growth Hormone Deficiency (GHD) were treated for 4 weeks with Saizen to compare…
- Trial name
- NCT01187550
- Testing
- Recombinant human growth hormone (r-hGH)
- Volunteers
- 214 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Growth Hormone Deficiency
Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH…
- Trial name
- NCT00163189
- Testing
- Somatropin
- Where
- 19 sites in France
- Volunteers
- 98 people
- Sponsor
- Pfizer
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 Disorder, Growth Hormone Deficiency in Children
Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment…
- Trial name
- NCT02616562
- Testing
- somapacitan, Norditropin® FlexPro® pen
- Where
- 89 sites in United States, Austria and 12 more
- Volunteers
- 76 people
- Sponsor
- Novo Nordisk A/S
Obesity, Short Stature
Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children
Background: Overweight and obese children and adults often have lower levels of growth hormone in the blood. Regulation of growth hormone may be tied to weight and free fatty acids in the blood.
- Conditions
- Obesity, Short Stature, Growth Hormone Deficiency
- Trial name
- NCT01237041
- Testing
- Niacin First, Dose-Establishing Study 1 Niacin 250mg, Dose-Establishing Study 1 Niacin 500mg
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Growth Hormone Deficiency
A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency
This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin) (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naïve to prior recombinant human growth hormone (rhGH)…
- Trial name
- NCT02311894
- Testing
- Somatropin
- Where
- 33 sites in United States
- Volunteers
- 82 people
- Sponsor
- Genentech, Inc.
Growth Hormone Deficiency, Turner Syndrome
Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN®
The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.
- Trial name
- NCT00256126
- Testing
- Saizen
- Where
- 13 sites in Argentina, Australia and 11 more
- Volunteers
- 318 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
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
Growth Hormone Deficiency
Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD
This is an open label randomized 24 week crossover trial assessing the treatment burden of a weekly growth hormone injection regimen (somatrogon) compared to a daily growth hormone injection regimen (Genotropin).
- Trial name
- NCT03831880
- Testing
- Genotropin, somatrogon
- Where
- 32 sites in United States, Bulgaria and 3 more
- Volunteers
- 87 people
- Sponsor
- Pfizer
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
Growth Hormone Deficiency (GHD)
Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis.
- Trial name
- NCT01947907
- Testing
- ACP-001, Human Growth Hormone
- Where
- 36 sites in Belarus, Bulgaria and 12 more
- Volunteers
- 53 people
- Sponsor
- Ascendis Pharma A/S
Growth Hormone Deficiency, Septo-Optic Dysplasia
Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
Hypotheses: 1. The prevalence of endocrinopathies, and growth hormone (GH) deficiency in particular, among young children diagnosed with optic nerve hypoplasia (ONH) is higher than is commonly thought. 2.
- Conditions
- Growth Hormone Deficiency, Septo-Optic Dysplasia, Hypopituitarism
- Trial name
- NCT00140413
- Testing
- Nutropin AQ
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Children's Hospital Los Angeles
Growth Hormone Deficiency (GHD)
Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
Protocol CP-4-004-OLE (Open Label Extension) is designed as a long-term, open-label extension using single patient use, multi-dose, disposable pre-filled pen.
- Trial name
- NCT02500316
- Testing
- MOD-4023
- Where
- 13 sites in United States, Belarus and 4 more
- Volunteers
- 48 people
- Sponsor
- OPKO Health, Inc.