Clinical trials: Growth Hormone Deficiency in Children
Growth Hormone Deficiency
Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation).
- Trial name
- NCT01495468
- Testing
- PEG-somatropin
- Where
- 6 sites in China
- Volunteers
- 343 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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 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, 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 Deficiency
Practicability and Acceptability of Stylomax® in Children
Primary objective: to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for MAXOMAT®, in children, for 1 year.
- Trial name
- NCT00476385
- Testing
- somatropine
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Sanofi
GHD
A Study to Investigate Efficacy and Safety of Weekly PEG-somatropin (GenSci004) in Treatment Naive Children With Growth Hormone Deficiency
The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD.
- Trial name
- ELEVATE (NCT06007417)
- Testing
- GenSci004, Genotropin
- Where
- United States
- Volunteers
- 162 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Growth Hormone Deficiency
Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children
The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.
- Trial name
- PD (NCT01342146)
- Testing
- pegylated Somatropin, Jintropin AQ
- Volunteers
- 101 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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
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 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, 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
Idiopathic Growth Hormone Deficiency, Turner Syndrome
First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study
PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to confirm that some genes can be used to predict how well a subject diagnosed with idiopathic growth hormone deficiency (IGHD) or turner…
- Trial name
- NCT01419249
- Testing
- Blood sampling
- Where
- 31 sites in Argentina, Canada and 7 more
- Volunteers
- 458 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
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.
Turner Syndrome, Short Stature Homeobox Gene Mutation
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and <18 years with open growth plates.
- Conditions
- Turner Syndrome, Short Stature Homeobox Gene Mutation, Idiopathic Short Stature, Small for Gestational Age at Delivery
- Trial name
- NCT07221851
- Testing
- Lonapegsomatropin [SKYTROFA®], Somatropin Pen Injector
- Where
- 56 sites in United States, France and 5 more
- Volunteers
- 186 people
- Sponsor
- Ascendis Pharma A/S
Pediatric Growth Hormone Deficiency
A Study of GenSci134 in Children With Growth Hormone Deficiency (PGHD)
This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation to assess safety, tolerability, PK/PD profile, and immunogenicity of…
- Trial name
- NCT07450001
- Testing
- GenSci134 Injection, Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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
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.
Growth Hormone-Deficiency
A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.
- Trial name
- NCT02092077
- Testing
- TV-1106, somatropin
- Where
- 34 sites in Belarus, Bulgaria and 11 more
- Volunteers
- 65 people
- Sponsor
- Teva Pharmaceutical Industries, 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