Clinical trials: Hormone Deficiency
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 Disorder
Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were…
- Trial name
- NCT00191074
- Testing
- somatropin, rDNA origin, for injection
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Eli Lilly and Company
Insulin-like Growth Factor-1 Deficiency
rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency
IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in response to another hormone called growth hormone. Growth Hormone is produced by a small gland at the base of the brain (the pituitary).
- Trial name
- NCT00572156
- Testing
- NutropinAq® (Somatropin [rDNA origin]), Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin])
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Ipsen
Growth Hormone Deficiency (GHD)
Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency
This is a Multi-national Trial. The Goal of the Trial is to Offer Subjects Who Complete 12 Months in the LUM-201-10 Phase 3 Trial up to an Additional 36 Months of Treatment of LUM-201 While Evaluating Safety and Tolerability of…
- Trial name
- NCT07129759
- Testing
- LUM-201
- Volunteers
- 150 people
- Sponsor
- Lumos Pharma
Pediatric Growth Hormone Deficiency
A Study to Compare the Experiences of Taking Daily Growth Hormone Injections to Weekly Ngenla in Children With Low Levels of Growth Hormone
The purpose of this study is to learn about: how children stick to taking their injections their experience with the study medicines (Ngenla and daily growth hormone) prescribed to children with low levels of growth hormone.
- Trial name
- NCT06113952
- Testing
- Sharps bin to collect used needles/injections
- Sponsor
- Pfizer
Hypogonadotropic Hypogonadism
Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
Sponsor has decided to discontinue Luveris® in the United States (US) due to level of customer demand for this product, and not due to any efficacy or safety concerns.
- Trial name
- NCT00328926
- Testing
- Luveris® 75 IU, Luveris® 25 IU, Recombinant human follicle stimulating hormone (r-hFSH)
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- EMD Serono
Growth Hormone Deficiency
Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency
To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of PEG…
- Trial name
- NCT02976675
- Testing
- PEG-somatropin
- Where
- 24 sites in China
- Volunteers
- 600 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Idiopathic Growth Hormone Deficiency
A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Study (FE 999905 CS07) of Zomacton in Children With Growth Hormone Deficiency
This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of anti-hGH antibodies at any post-dosing visit…
- Trial name
- NCT02173821
- Testing
- Blood sampling
- Where
- 7 sites in Hungary, India and 5 more
- Volunteers
- 23 people
- Sponsor
- Ferring Pharmaceuticals
Childhood-onset Growth Hormone Deficiency, Pituitary Dwarfism
Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency
The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to…
- Trial name
- NCT00109733
- Testing
- recombinant human growth hormone
- Where
- 9 sites in United States
- Volunteers
- 31 people
- Sponsor
- EMD Serono
Growth Hormone Deficiency
Adipocyte Function and Somtropin Deficiency
To assess the influence of exogenous GH (growth hormone) administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children with delayed growth due to GH deficiency.
- Trial name
- FAYDS (NCT01351818)
- Testing
- Growth Hormone
- Where
- 12 sites in Spain
- Volunteers
- 62 people
- Sponsor
- Ferring Pharmaceuticals
Growth Hormone Deficiency
A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin
The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.
- Trial name
- SkyPASS (NCT05775523)
- Testing
- No intervention
- Where
- 27 sites in United States
- Volunteers
- 500 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
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
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, Endocrine System Diseases
Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency
This study is conducted in China only. The purpose is to demonstrate the efficacy and safety of once weekly dosing of TransCon hGH, a long-acting growth hormone product, compare to once-daily dosing of human growth hormone (hGH)…
- Conditions
- Growth Hormone Deficiency, Endocrine System Diseases, Hormones, Pituitary Diseases
- Trial name
- NCT04326374
- Testing
- TransCon hGH, daily hGH
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Visen Pharmaceuticals (Shanghai) Co., Ltd.
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.
Adult Growth Hormone Deficiency
A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).
- Trial name
- NCT01909479
- Testing
- MOD-4023
- Where
- Israel
- Volunteers
- 202 people
- Sponsor
- OPKO Health, Inc.
Growth Hormone Disorder, Adult Growth Hormone Deficiency
Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
This study is conducted in the United States of America (USA). The aim of the study is to assess the minimal important difference (MID) of the TRIM-AGHD.
- Trial name
- NCT02005198
- Testing
- No treatment given
- Where
- United States
- Volunteers
- 98 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.
Dwarfism, Pituitary
Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad population of children.
- Trial name
- NCT02314676
- Testing
- PEG-somatropin
- Where
- 2 sites in China
- Volunteers
- 900 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Adult Growth Hormone Deficiency
A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9
This is a randomized, active-controlled, open-label, sequential dose group, Phase 1b/2 study designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of weekly and every other week doses of…
- Trial name
- NCT02946606
- Testing
- GX-H9, Genotropin
- Where
- South Korea
- Volunteers
- 45 people
- Sponsor
- Genexine, Inc.