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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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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 1 of 4.
    1  2  3  4  Next»
    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
    Disease: Version SOC Term Classification Code Term Level
    8.1 10056438 LLT
    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: 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
    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: FR (Completed) BE (Completed) SI (Completed) GB (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-002736-13 Sponsor Protocol Number: TV1106-IMM-30022 Start Date*: 2015-08-19
    Sponsor Name:Teva Pharmaceutical Industries Ltd.
    Full Title: A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-de...
    Medical condition: Growth hormone deficiency
    Disease: Version SOC Term Classification Code Term Level
    19.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Completed) SE (Prematurely Ended) IT (Prematurely Ended) AT (Completed) ES (Prematurely Ended) SI (Prematurely Ended) LT (Prematurely Ended) GR (Prematurely Ended) CZ (Prematurely Ended) PL (Prematurely Ended) SK (Prematurely Ended) HR (Prematurely Ended)
    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
    Disease: Version SOC Term Classification Code Term Level
    19.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) BE (Completed) NL (Ongoing) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-001681-25 Sponsor Protocol Number: 23681 Start Date*: 2015-07-15
    Sponsor Name:Merck KGaA
    Full Title: An Open, Multicenter, Randomized, Controlled Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Ex...
    Medical condition: Small for Gestational Age
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-001826-61 Sponsor Protocol Number: 11‐HM10560A‐201 Start Date*: 2011-07-29
    Sponsor Name:Hanmi Pharmaceutical Co., Ltd.
    Full Title: A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone defic...
    Medical condition: Adult growth hormone deficiency (AGHD)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-019374-32 Sponsor Protocol Number: CP-4-003 Start Date*: 2010-07-15
    Sponsor Name:ModigeneTech Ltd.
    Full Title: A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)
    Medical condition: Growth Hormone Deficiency
    Disease: Version SOC Term Classification Code Term Level
    12.1 10056438 Growth hormone deficiency LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SK (Completed) HU (Completed) SI (Completed) CZ (Completed) DE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-005587-82 Sponsor Protocol Number: A6391003 Start Date*: 2006-06-12
    Sponsor Name: [...]
    1.
    2. Pfizer AB
    3. Pfizer Ltd
    Full Title: A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients
    Medical condition: 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: SE (Prematurely Ended) DE (Prematurely Ended) DK (Completed) BE (Completed) GB (Completed) NL (Prematurely Ended) IT (Prematurely Ended) CZ (Prematurely Ended) PL (Completed) GR (Prematurely Ended)
    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
    Disease: Version SOC Term Classification Code Term Level
    18.1 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2005-000384-26 Sponsor Protocol Number: BPLG-005 Start Date*: 2005-11-10
    Sponsor Name:LG Life Science Ltd. [...]
    1. LG Life Science Ltd.
    2. BioPartners
    Full Title: A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.
    Medical condition: growth hormone deficiency in adults
    Disease: Version SOC Term Classification Code Term Level
    8.0 10056438 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) ES (Ongoing) SE (Completed) CZ (Completed) GB (Completed) SK (Completed) FR (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002698-13 Sponsor Protocol Number: GX-H9-002 Start Date*: 2015-01-14
    Sponsor Name:Genexine, Inc
    Full Title: A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adu...
    Medical condition: Adult Growth Hormone Deficiency (AGHD)
    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: SK (Completed) HU (Completed) SE (Completed) DE (Completed) GR (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-002278-24 Sponsor Protocol Number: BPLG-005-RO Start Date*: 2006-10-06
    Sponsor Name:BioPartners GmbH
    Full Title: A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency.
    Medical condition: Growth hormone deficiency in adults
    Disease: Version SOC Term Classification Code Term Level
    8.1 10056438 Growth hormone deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) AT (Completed) GB (Completed) FR (Ongoing) SE (Completed) SK (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-019296-30 Sponsor Protocol Number: Start Date*: 2010-05-18
    Sponsor Name:University Hospital Birmingham NHS Foundation Trust
    Full Title: A pharmacokinetic and pharmacodynamic study of recombinant human IGF-I (rhIGF-I) in three boys with ALS deficiency, and insulin sensitivity and bone density in patients and heterozygous first-degre...
    Medical condition: ALS (acid label subunit) deficiency
    Disease: Version SOC Term Classification Code Term Level
    12.1 10056438 Growth Hormone Deficiency LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    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
    Disease: Version SOC Term Classification Code Term Level
    17.0 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    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: 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...
    Disease: Version SOC Term Classification Code Term Level
    7.1 10056438 PT
    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: 2012-004975-37 Sponsor Protocol Number: TV1106-GHD-201 Start Date*: 2013-01-21
    Sponsor Name:Teva Pharmaceutical Industries Ltd.
    Full Title: A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with G...
    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, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) SK (Completed) GR (Completed) SI (Completed) DE (Completed) SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002802-34 Sponsor Protocol Number: Sandoz/OMNI/F/01/03 Start Date*: 2015-07-03
    Sponsor Name:Sandoz SAS
    Full Title: Multicentre study to evaluate the efficacy and safety of a liquid formulation of recombinant growth hormone, Omnitrope® 3.3mg/mL, in the treatment of pre-pubertal children of small stature sufferin...
    Medical condition: Small stature secondary to growth hormone insufficiency deficiency
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-001539-31 Sponsor Protocol Number: FE999905 CS002 Start Date*: 2005-09-16
    Sponsor Name:Ferring Pharmaceuticals A/S
    Full Title: An Open-label, Multi-centre, Phase III Study of Local Tolerability of Zomacton 10 mg (Recombinant Somatropin) administered by ZomaJet Vision X
    Medical condition: Zomacton is indicated for the long term treatment of children who have growth failure due to inadequate secretion of growth hormone and for the long-term treatment of growth retardation due to Turn...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2008-001061-29 Sponsor Protocol Number: NN8630-1823 Start Date*: 2008-06-17
    Sponsor Name:Novo Nordisk A/S
    Full Title: A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated lo...
    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: DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-001939-21 Sponsor Protocol Number: GX-H9-003 Start Date*: 2015-07-16
    Sponsor Name:Genexine, Inc.
    Full Title: A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone defic...
    Medical condition: Growth Hormone Deficiency (GHD) in pre-pubertal children
    Disease: Version SOC Term Classification Code Term Level
    19.1 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Prematurely Ended) SK (Completed) GR (Completed) PL (Completed) EE (Prematurely Ended) LT (Prematurely Ended) LV (Prematurely Ended)
    Trial results: (No results available)
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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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