Clinical trials: Growth Hormone Disorder
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 Disorder, Adult Growth Hormone Deficiency
Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients
This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.
- Trial name
- NCT01562834
- Testing
- somatropin
- Where
- 24 sites in France
- Volunteers
- 22 people
- Sponsor
- Novo Nordisk 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 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, Adult Growth Hormone Deficiency
A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092, somapacitan) compared to once…
- Trial name
- NCT01706783
- Testing
- somapacitan, Norditropin NordiFlex®
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 35 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 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
Growth Hormone Disorder, Adult Growth Hormone Deficiency
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese…
- Trial name
- NCT03075644
- Testing
- somapacitan, Norditropin
- Where
- 12 sites in Japan
- Volunteers
- 62 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
Adult Growth Hormone Deficiency, Growth Hormone Disorder
A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency
This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered…
- Trial name
- REAL 2 (NCT02382939)
- Testing
- somapacitan, somatropin
- Where
- 28 sites in Denmark, France and 4 more
- Volunteers
- 92 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 Disorder, Adult Growth Hormone Deficiency
French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin
This study is conducted in Europe. The aim of this study is to extract data from the French National Registry holding information about patients having initiated growth hormone therapy with the objective to describe patients…
- Trial name
- NCT01580605
- Testing
- somatropin
- Where
- France
- Volunteers
- 331 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 (GH) Deficiency, Short Stature Homeobox Containing Gene (SHOX) Deficiency
Observational Study of Somatropin Treatment in Children
GeNeSIS is an open-label, multinational, multicenter, observational study to evaluate the safety and effectiveness of Humatrope treatment.
- Conditions
- Growth Hormone (GH) Deficiency, Short Stature Homeobox Containing Gene (SHOX) Deficiency, SHOX Deficiency-related Disorder, Non-GH-deficient Growth Disorders
- Trial name
- GeNeSIS (NCT01088412)
- Testing
- Somatropin (recombinant deoxyribonucleic acid [rDNA] origin)
- Volunteers
- 22,845 people
- Sponsor
- Eli Lilly and Company
Growth Hormone Disorders
A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency
This study is a multicenter, open-label, observational, post marketing surveillance program to collect information on the use of NutropinAq® in adults suffering from Growth Hormone Deficiency in Germany, Italy, and United Kingdom
- Trial name
- NCT00455884
- Where
- United Kingdom
- Volunteers
- 546 people
- Sponsor
- Ipsen
Growth Hormone Disorders
A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders
This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safety and effectiveness…
- Trial name
- iNCGS (NCT00455728)
- Where
- United Kingdom
- Volunteers
- 3,690 people
- Sponsor
- Ipsen
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 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, Pituitary Dwarfism
An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone)
This study is conducted in the United States of America (USA). The aim of this observational study is to collect data concerning the treatment outcomes and safety for children and adults who are prescribed Norditropin®.
- Conditions
- Growth Hormone Disorder, Pituitary Dwarfism, Hypopituitarism
- Trial name
- ANSWER (NCT01009905)
- Testing
- somatropin
- Where
- United States
- Volunteers
- 22,960 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth Hormone Deficiency, comparing two different…
- Trial name
- NCT00184743
- Testing
- somatropin
- Where
- Japan
- Volunteers
- 112 people
- Sponsor
- Novo Nordisk A/S