- Trials with a EudraCT protocol (47)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
47 result(s) found for: Growth Hormone Deficiency in Children.
Displaying page 1 of 3.
EudraCT Number: 2013-000013-20 | Sponsor Protocol Number: NN8640-4042 | Start Date*: 2013-12-09 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth... | |||||||||||||
Medical condition: Growth hormone deficiency in children | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: SI (Completed) BE (Completed) AT (Completed) SE (Completed) ES (Completed) FR (Ongoing) | |||||||||||||
Trial results: View results |
EudraCT Number: 2008-008240-25 | Sponsor Protocol Number: NN8630-1824 | Start Date*: 2009-09-02 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: A randomised, open-labelled, single dose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083)... | |||||||||||||
Medical condition: growth hormone deficiency (GHD) in children | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: FR (Completed) BE (Completed) SI (Completed) GB (Completed) ES (Completed) DK (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2005-005593-79 | Sponsor Protocol Number: A6391004 | Start Date*: 2006-06-02 | |||||||||||
Sponsor Name:Pfizer Limited | |||||||||||||
Full Title: A Double blind, third party open, single dose study to explore the safety, pharmacokinetics and pharmacodynamics of pha-794428 in paediatric patients with growth hormone deficiency | |||||||||||||
Medical condition: Paediatric Growth Hormone Deficiency | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) ES (Completed) BE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2004-005054-31 | Sponsor Protocol Number: 24531 | Start Date*: 2005-07-15 | |||||||||||
Sponsor Name:Serono International S.A. | |||||||||||||
Full Title: A phase IV open-label study of predictive markers in Growth Hormone Deficient and Turner Syndrome prepubertal children treated with Saizen | |||||||||||||
Medical condition: - growth failure in children caused by decreased or absent secretion of endogenous growth hormone. - growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal anal... | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) FI (Completed) ES (Completed) DE (Completed) AT (Completed) SE (Completed) IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2022-001695-34 | Sponsor Protocol Number: LUM-201-04 | Start Date*: 2022-09-08 | |||||||||||
Sponsor Name:Lumos Pharma, Inc. | |||||||||||||
Full Title: An Open-Label, Multicenter, Phase 2 Study to Evaluate Growth and Safety of LUM-201 Following 12 Months of Daily rhGH Treatment in Children with Idiopathic Growth Hormone Deficiency who have Previou... | |||||||||||||
Medical condition: Growth hormone deficiency | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: PL (Completed) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2008-001674-32 | Sponsor Protocol Number: NordiNet-IOS | Start Date*: 2009-04-29 | |||||||||||
Sponsor Name:Novo Nordisk Farma Oy | |||||||||||||
Full Title: NordiNet International Outcome Study (NordiNet IOS) | |||||||||||||
Medical condition: Small Gestation Age, Turner Syndrome, Growth Hormone Deficiency | |||||||||||||
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Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: FI (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-004525-41 | Sponsor Protocol Number: 14VR4 | Start Date*: 2015-04-10 | |||||||||||
Sponsor Name:Versartis, Inc. | |||||||||||||
Full Title: Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children w... | |||||||||||||
Medical condition: Growth hormone deficiency | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: SE (Completed) BE (Completed) NL (Ongoing) PL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-000446-56 | Sponsor Protocol Number: CRT076 | Start Date*: 2016-03-07 | |||||||||||
Sponsor Name:Cristália Produtos Químicos Farmacêuticos Ltda. | |||||||||||||
Full Title: Clinical study to compare recombinant human growth hormone Cristalia (r-hGH Cristalia) versus Genotropin® in prepubertal children with growth deficiency due to deficiency of growth hormone. | |||||||||||||
Medical condition: Growth deficiency due to growth hormone deficiency | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2018-000231-27 | Sponsor Protocol Number: NN8640-4263 | Start Date*: 2019-04-23 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency | |||||||||||||
Medical condition: Growth hormone deficiency in children | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Ongoing) FR (Trial now transitioned) DK (Completed) AT (Ongoing) SI (Trial now transitioned) GB (GB - no longer in EU/EEA) NO (Ongoing) IE (Completed) EE (Completed) LV (Trial now transitioned) PL (Trial now transitioned) HU (Completed) ES (Ongoing) IT (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2015-000531-32 | Sponsor Protocol Number: NN8640-4172 | Start Date*: 2015-12-10 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared... | |||||||||||||
Medical condition: Growth hormone deficiency in children | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: AT (Completed) SE (Completed) SI (Completed) DE (Completed) BE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-003410-20 | Sponsor Protocol Number: TransCon_hGH_CT-301EXT | Start Date*: 2018-04-20 | |||||||||||
Sponsor Name:Ascendis Pharma Endocrinology Division A/S | |||||||||||||
Full Title: enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have C... | |||||||||||||
Medical condition: Growth hormone deficiency (GHD) in prepubertal children | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: BG (Completed) GR (Completed) IT (Completed) PL (Completed) RO (Ongoing) | |||||||||||||
Trial results: View results |
EudraCT Number: 2004-000356-17 | Sponsor Protocol Number: 2 79 58035 700 | Start Date*: Information not available in EudraCT |
Sponsor Name:Beaufour Ipsen Pharma | ||
Full Title: PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQ USING A NOVEL CAPILLARY BLOOD COLLECTION METHOD | ||
Medical condition: growth failure associated with: - inadequate growth hormone secretion - Turner syndrome, confirmed by karyotype - chronic renal insufficiency up to renal transplantation | ||
Disease: | ||
Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | |
Trial protocol: ES (Ongoing) IT (Completed) DK (Completed) AT (Completed) SE (Completed) FI (Completed) | ||
Trial results: View results |
EudraCT Number: 2020-002974-28 | Sponsor Protocol Number: NN8640-4468 | Start Date*: 2023-07-12 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: A trial comparing the efficacy and safety of once weekly dosing of somapacitan with daily Norditropin® in Chinese children with growth hormone deficiency | |||||||||||||
Medical condition: Growth hormone deficiency in children | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-003874-42 | Sponsor Protocol Number: CP-4-006 | Start Date*: 2017-09-04 | |||||||||||
Sponsor Name:OPKO Biologics Ltd. | |||||||||||||
Full Title: A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency | |||||||||||||
Medical condition: Growth hormone deficiency in pre-pubertal children | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) BG (Completed) FR (Completed) PL (Completed) ES (Ongoing) GR (Completed) IT (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2013-004468-69 | Sponsor Protocol Number: TV1106-IMM-20001 | Start Date*: 2014-06-11 | |||||||||||
Sponsor Name:Teva Pharmaceutical Industries, Ltd. | |||||||||||||
Full Title: A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive,... | |||||||||||||
Medical condition: Growth hormone deficiency | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: HU (Prematurely Ended) CZ (Prematurely Ended) RO (Ongoing) GR (Prematurely Ended) BG (Prematurely Ended) ES (Prematurely Ended) PL (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2011-000460-10 | Sponsor Protocol Number: EMR200104_10 | Start Date*: 2011-08-03 | ||||||||||||||||
Sponsor Name:Merck Serono SA | ||||||||||||||||||
Full Title: 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 V... | ||||||||||||||||||
Medical condition: idiopathic growth hormone deficienty Turner Syndrome | ||||||||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | |||||||||||||||||
Trial protocol: GB (Completed) ES (Completed) CZ (Completed) IT (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2005-000346-36 | Sponsor Protocol Number: BPLG-004 | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:BioPartners GmbH [...] | |||||||||||||
Full Title: A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Dai... | |||||||||||||
Medical condition: pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: AT (Completed) FI (Prematurely Ended) SE (Prematurely Ended) SK (Completed) HU (Completed) CZ (Prematurely Ended) IT (Completed) DE (Completed) LT (Prematurely Ended) EE (Prematurely Ended) LV (Prematurely Ended) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2008-004849-28 | Sponsor Protocol Number: FE 999905 CS07 | Start Date*: 2009-07-09 | |||||||||||
Sponsor Name:Ferring Pharmaceuticals A/S | |||||||||||||
Full Title: A randomised, open-label, parallel-group, multi-centre trial comparing the efficacy and safety of 12 months treatment with one daily dose of ZOMACTON® to one daily dose of GENOTROPIN® in the treatm... | |||||||||||||
Medical condition: Idiopathic growth hormone deficiency. | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: HU (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2018-000918-38 | Sponsor Protocol Number: C0311002 | Start Date*: 2019-05-16 | |||||||||||
Sponsor Name:Pfizer Inc. | |||||||||||||
Full Title: A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROP... | |||||||||||||
Medical condition: Growth Hormone Deficiency in Children | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) SK (Completed) CZ (Completed) BG (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-001145-11 | Sponsor Protocol Number: TransCon_hGH_CT-301 | Start Date*: 2018-02-12 | |||||||||||
Sponsor Name:Ascendis Pharma Endocrinology Division A/S | |||||||||||||
Full Title: A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard... | |||||||||||||
Medical condition: Growth hormone deficiency (GHD) in prepubertal children | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) IT (Completed) BG (Completed) PL (Completed) GR (Completed) | |||||||||||||
Trial results: View results |
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