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Clinical trials for Recombinant human growth hormone

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   44346   clinical trials with a EudraCT protocol, of which   7374   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    72 result(s) found for: Recombinant human growth hormone. Displaying page 2 of 4.
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    EudraCT Number: 2020-000874-92 Sponsor Protocol Number: LUM-201-01 Start Date*: 2021-03-22
    Sponsor Name:Lumos Pharma, Inc.
    Full Title: A Multicenter, 24-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children with Idiopathic Growth Hormone Deficie...
    Medical condition: Growth hormone deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-000563-41 Sponsor Protocol Number: IMIMFTCL/GH/4 Start Date*: 2014-08-08
    Sponsor Name:Consorci Mar Parc de Salut de Barcelona (Parc de Salut Mar)
    Full Title: Recombinant hGH Biomarkers Discovery
    Medical condition: Healthy volunteers. There is not intended indication.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    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
    EudraCT Number: 2007-000790-36 Sponsor Protocol Number: A6281282 Start Date*: 2008-01-08
    Sponsor Name:Pfizer Pharma GmbH
    Full Title: Prospective, randomized, double blind placebo-controlled trial on the efficacy of growth hormone replacement therapy in adult patients with isolated growth hormone deficiency (PRO ISO-GHD Study)
    Medical condition: Isolated Adult Growth Hormone Deficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056438 Growth hormone deficiency LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-000432-26 Sponsor Protocol Number: versie1,dd01-02-2012 Start Date*: 2012-09-26
    Sponsor Name:Maastricht University Medical Centre
    Full Title: Prospective study on the metabolic and linear growth effects of growh hormone treatment in children with Kabuki Syndrome
    Medical condition: Kabuki Syndrome (KS, OMIM 147920) with a mutation in MLL2 gene.
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-000929-42 Sponsor Protocol Number: TCH-306 Start Date*: 2021-06-09
    Sponsor Name:Ascendis Pharma Endocrinology Division A/S
    Full Title: foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin ...
    Medical condition: Adult Growth Hormone Deficiency (AGHD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SK (Completed) FR (Completed) DK (Prematurely Ended) BG (Completed) ES (Ongoing) NL (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-004553-60 Sponsor Protocol Number: CP-4-004 Start Date*: 2012-01-10
    Sponsor Name:OPKO Biologics Ltd.
    Full Title: Safety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone deficient children
    Medical condition: Pediatric Growth Hormone Deficiency
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) SK (Ongoing) CZ (Prematurely Ended) GR (Completed) PL (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003796-32 Sponsor Protocol Number: TV1106-IMM-30021 Start Date*: 2015-08-21
    Sponsor Name:Teva Pharmaceutical Industries Ltd.
    Full Title: A phase 3, multicenter, randomized, double-blind, placebo-controlled efficacy, safety and tolerability study of TV-1106 in growth hormone-deficient adults who are not current users of rhGH treatment
    Medical condition: Growth hormone deficiency
    Disease: Version SOC Term Classification Code Term Level
    17.1 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Prematurely Ended) CZ (Prematurely Ended) IT (Completed) AT (Prematurely Ended) ES (Prematurely Ended) SI (Prematurely Ended) LT (Prematurely Ended) GR (Prematurely Ended) PL (Prematurely Ended) BG (Prematurely Ended) RO (Prematurely Ended) SK (Prematurely Ended) HR (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
    Disease: Version SOC Term Classification Code Term Level
    13.1 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    13.1 10010331 - Congenital, familial and genetic disorders 10045181 Turner's syndrome PT
    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 [...]
    1. BioPartners GmbH
    2. LG Life Science Ltd.
    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
    Disease: Version SOC Term Classification Code Term Level
    10056438 LLT
    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.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056438 Growth hormone deficiency LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2005-004451-35 Sponsor Protocol Number: MRTSH01505 Start Date*: 2007-03-13
    Sponsor Name:Genzyme Europe BV
    Full Title: Study to Evaluate the Dose, Safety and Effectiveness of Modified-Release Recombinant Human Thyroid Stimulating Hormone (MRrhTSH) When Used in Conjunction with Radioiodine for the Treatment of Multi...
    Medical condition: Nodular goiter are clinically recognizable enlargements of the thyroid gland characterized by excessive growth and structural and or functional transformation of one or several areas within the nor...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10043808 Thyrotropin LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DK (Completed) FR (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-001746-40 Sponsor Protocol Number: PRO-ARX201-701 Start Date*: 2008-08-25
    Sponsor Name:Ambrx, Inc., USA
    Full Title: A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone D...
    Medical condition: Growth Hormone Deficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056438 Growth hormone deficiency LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2013-000830-37 Sponsor Protocol Number: CP-4-005 Start Date*: 2013-07-03
    Sponsor Name:OPKO Biologics Ltd.
    Full Title: A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency
    Medical condition: Adult or childhood onset growth hormone deficiency (GHD)
    Disease: Version SOC Term Classification Code Term Level
    19.1 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) GR (Completed) GB (Completed) AT (Completed) ES (Prematurely Ended) NL (Completed) PL (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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    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: 2015-002072-24 Sponsor Protocol Number: 15VR7 Start Date*: 2015-10-22
    Sponsor Name:Versartis Inc.
    Full Title: An Open-Label, Dose Finding, International Phase 2 Study with Once Monthly Subcutaneous Somavaratan (VRS-317) in Adult Growth Hormone Deficiency (GHD) Versartis International Trial in Adults with ...
    Medical condition: Growth Hormone Deficiency in adults
    Disease: Version SOC Term Classification Code Term Level
    18.1 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-000844-81 Sponsor Protocol Number: MS306 Start Date*: 2019-05-31
    Sponsor Name:Ipsen Pharma
    Full Title: RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-1 (rhIGF-1) TREATMENT OF CHILDREN AND ADOLESCENTS WITH GROWTH FAILURE ASSOCIATED WITH PRIMARY IGF-1 DEFICIENCY: AN OPEN-LABEL, MULTI-CENTER, EXTENSION S...
    Medical condition: Children and adolescents with growth failure associated with primary insulin-like growth factor deficiency (IGFD).
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-016783-37 Sponsor Protocol Number: WS475202 Start Date*: 2010-01-07
    Sponsor Name:Sahlgrenska University Hospital
    Full Title: The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of L...
    Medical condition: Growth hormone deficiency in adults
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    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: 2015-002613-30 Sponsor Protocol Number: GH-3899 Start Date*: 2016-04-25
    Sponsor Name:Novo Nordisk A/S
    Full Title: A 12-month, open-labelled, randomised, parallel-group, multi-centre, interventional trial to evaluate the efficacy and safety of recombinant human growth hormone (hGH) (Norditropin® Nordilet®) ther...
    Medical condition: Idiopathic short stature
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004859 10066333 Idiopathic short stature LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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