Clinical trials: Hormone Deficiency
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
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
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
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.
Growth Hormone Deficiency
A Study of Zomacton in Children With Growth Hormone Deficiency
This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone deficiency in children. The children will be treated for 1 year.
- Trial name
- NCT00884000
- Testing
- Genotropin, Zomacton
- Where
- 43 sites in Hungary, India and 5 more
- Volunteers
- 165 people
- Sponsor
- Ferring Pharmaceuticals
Growth Hormone Deficiency
Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®
The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.
- Trial name
- NCT01731028
- Testing
- Somatropin
- Sponsor
- Ferring Pharmaceuticals
Growth Hormone Deficiency, Idiopathic Short Stature
Genotropin Study Assessing Use of Injection Pen
Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and preference of Genotropin injection pen. Patients already on genotropin will be asked to use a genotropin pen for 2 months.
- Trial name
- NCT00965484
- Testing
- New Genotropin Pen
- Where
- 25 sites in United States
- Volunteers
- 136 people
- Sponsor
- Pfizer
Brain Injuries, Growth Hormone Deficiency
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
- Trial name
- NCT00555009
- Testing
- Genotropin
- Where
- 9 sites in France, Italy and 4 more
- Volunteers
- 10 people
- Sponsor
- Pfizer
Growth Hormone Disorder, Adult Growth Hormone Deficiency
An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin®
This observational study is conducted in Europe. The aim of this observational study is to investigate the changes in a score (GET-score) which includes quality of life, body composition and cholesterol metabolism in patients on…
- Trial name
- GET (NCT00934063)
- Testing
- somatropin, No treatment given
- Where
- Germany
- Volunteers
- 121 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Deficiency
A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency
The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.
- Trial name
- NCT00308464
- Testing
- PHA-794428
- Where
- 35 sites in Belgium, Czechia and 10 more
- Volunteers
- 136 people
- Sponsor
- Pfizer
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks…
- Trial name
- REAL 1 (NCT02229851)
- Testing
- somapacitan, somatropin
- Where
- 117 sites in United States, Australia and 17 more
- Volunteers
- 301 people
- Sponsor
- Novo Nordisk A/S
GHD
A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency
The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.
- Trial name
- ESCALATE (NCT06024967)
- Testing
- PEG-somatropin
- Volunteers
- 180 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Primary Insulin-like Growth Factor-1 Deficiency
IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
This project is a retrospective (beginning January 2006) and prospective patient registry program sponsored by Ipsen (formerly Tercica, Inc.).
- Trial name
- NCT00747604
- Testing
- mecasermin [rDNA origin] injection
- Where
- United States
- Volunteers
- 1,378 people
- Sponsor
- Ipsen
Adult Growth Hormone Deficiency
Versartis International Trial in Adults With Long-Acting Growth Hormone
A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.
- Trial name
- VITAL (NCT02526420)
- Testing
- somavaratan
- Where
- 18 sites in United States, Australia and 2 more
- Volunteers
- 36 people
- Sponsor
- Versartis Inc.
Idiopathic Growth Hormone Deficiency
Comparing Efficacy and Safety of CinnaGen Biosimilar Growth Hormone (CinnaTropin®) Versus Nordilet in Children With Idiopathic Growth Hormone Deficiency
This randomized, active-controlled, two-armed, open-label, and cross-over trial was designed to compare efficacy and safety of 0.03 mg/kg/day subcutaneous injections of either CinnaTropin® or Novo Nordisk growth hormone product…
- Trial name
- NCT03223025
- Testing
- CinnaTropin®, Nordilet®
- Volunteers
- 30 people
- Sponsor
- Cinnagen
Growth Hormone Deficiency in Children
A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.
The study compares two medicines for children with a low level of hormone to grow: somapacitan (a new medicine) given once a week and Norditropin® (a medicine doctors can already prescribe) given once a day.
- Trial name
- NCT04970654
- Testing
- somapacitan, Norditropin®
- Where
- 32 sites in China
- Volunteers
- 110 people
- Sponsor
- Novo Nordisk A/S
Adult Growth Hormone Deficiency
Metabolic Endocrinology and Growth Hormone in Adults
This is a multicentric, longitudinal, observational study with the prospective follow-up of Adult subjects with Growth Hormone Deficiency (AGHD) being treated with Saizen, every six months in the first year and then annually.
- Trial name
- MEGHA FRANCE (NCT01080755)
- Volunteers
- 90 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Dwarfism, Growth Hormone Deficiency
A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood
This was a 48-week, open-label, prospective, multicentric, randomised, comparative with parallel control, Phase 4 study to evaluate the effects of Saizen on cardiac function in GHD subjects during the transition phase from…
- Trial name
- NCT01157793
- Testing
- r-hGH
- Volunteers
- 34 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
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.
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