Clinical trials: Growth Hormone Deficiency in Children
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 in Children, Born Small for Gestational Age
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Participants are free to decide if they want to take part in this study or not. The study will be conducted to collect information about the influence of adherence to growth hormone therapy with Norditropin® in children and…
- Trial name
- NCT03972345
- Testing
- Norditropin® FlexPro®
- Where
- Germany
- Volunteers
- 750 people
- Sponsor
- Novo Nordisk A/S
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 in Children
Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed
The purpose of the study is to investigate the safety and effectiveness of Sogroya® in children with short stature due to growth hormone deficiency where epiphysial discs are not closed under real-world clinical practice in…
- Trial name
- NCT06109935
- Testing
- Somapacitan
- Where
- 86 sites in Japan
- Volunteers
- 200 people
- Sponsor
- Novo Nordisk A/S
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
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
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 Disorder, Adult Growth Hormone Deficiency
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of…
- Conditions
- Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children, Healthy
- Trial name
- NCT01514500
- Testing
- somapacitan
- Where
- Germany
- Volunteers
- 105 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Growth Hormone Deficiency in Children
A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency
This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on…
- Trial name
- NCT01973244
- Testing
- somapacitan, somatropin
- Where
- 22 sites in Austria, Belgium and 8 more
- Volunteers
- 32 people
- Sponsor
- Novo Nordisk A/S
Growth Disorder, Growth Hormone Deficiency in Children
Validation of Two Measures for Growth Hormone Deficiency in Children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD)
This study is conducted in Europe and the United States of America (USA). The aim of the study is to validate two measures for growth hormone deficiency in children, the Treatment Related Impact Measure of Childhood Growth…
- Trial name
- NCT02580032
- Testing
- No treatment given
- Where
- 28 sites in United States, United Kingdom
- Volunteers
- 252 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring…
- Conditions
- Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children
- Trial name
- NCT03186495
- Testing
- Somapacitan
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Deficiency in Children
Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy
The aim of the study is to examine the suitability, the so-called validation, of a questionnaire, with which one can grasp the reasons why injections of growth hormones are omitted by patients ("non-adherence").
- Trial name
- NCT03672617
- Testing
- No treatment given
- Where
- Germany
- Volunteers
- 321 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.
This trial is conducted in Europe. The aim of this trial is to investigate the effect of abnormal liver (hepatic) function on the amount of trial drug getting into the body and removal of the drug from the body (this is called…
- Conditions
- Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children
- Trial name
- NCT03212131
- Testing
- Somapacitan
- Where
- Slovakia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Observational Prospective Study on Patients Treated With Norditropin®
This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Adult Growth Hormone Deficiency, Genetic Disorder
- Trial name
- NCT00960128
- Testing
- somatropin
- Where
- 23 sites in Argentina, Belgium and 21 more
- Volunteers
- 21,249 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.
- Trial name
- NCT00567385
- Testing
- somatropin
- Where
- Turkey (Türkiye)
- Volunteers
- 176 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with…
- Trial name
- NCT01502124
- Testing
- somatropin
- Where
- 21 sites in United States
- Volunteers
- 78 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex® device to the device previously used by patients or parents.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age
- Trial name
- NCT01245374
- Testing
- Norditropin NordiFlex®
- Where
- France
- Volunteers
- 103 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid somatropin formulation in children with growth hormone deficiency.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome
- Trial name
- NCT01563926
- Testing
- somatropin
- Where
- 6 sites in Israel
- Volunteers
- 168 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Growth Hormone Deficiency in Children
A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and…
- Trial name
- NCT00936403
- Testing
- NNC126-0083, somatropin
- Where
- 21 sites in Belgium, Czechia and 8 more
- Volunteers
- 31 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Effect of Growth Hormone in Children With Growth Hormone Deficiency
This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Growth Disorder, Idiopathic Short Stature
- Trial name
- NCT00262249
- Testing
- somatropin
- Where
- 40 sites in United States
- Volunteers
- 173 people
- Sponsor
- Novo Nordisk A/S