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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   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 3 of 4.
    EudraCT Number: 2010-022215-19 Sponsor Protocol Number: GHIGF1/2011 Start Date*: 2011-07-21
    Sponsor Name:Greater Glasgow & Clyde NHS
    Full Title: A Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease
    Medical condition: Impaired growth in Paediatric Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004856 10011398 Crohn's LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-006212-30 Sponsor Protocol Number: IMIRC1002 Start Date*: 2007-08-09
    Sponsor Name:Imperial College London
    Full Title: A Randomised, Open labelled, Phase II, Immunogenicity, and Exploratory Efficacy Evaluation of Therapeutic Immunisations +/- IL-2, GM-CSF and Growth Hormone in HIV-1 Infected Subjects Receiving High...
    Medical condition: HIV-1
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-002787-27 Sponsor Protocol Number: ACP-001_CT-004 Start Date*: 2013-02-11
    Sponsor Name:Ascendis Pharma A/S
    Full Title: A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once we...
    Medical condition: Growth Hormone Deficiency (GHD) in pre-pubertal children
    Disease: Version SOC Term Classification Code Term Level
    17.1 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) CZ (Completed) GR (Completed) BG (Completed) SI (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-020742-10 Sponsor Protocol Number: 8-79-52800-011 Start Date*: 2011-05-09
    Sponsor Name:Ipsen Pharma
    Full Title: Recombinant Human Insulin-like Growth Factor (rhIGF-1) and Growth Hormone (rhGH) Combination Therapy of Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency and Poor Response to First Ye...
    Medical condition: Pre-Pubertal Children with Idiopathic Growth Hormone Deficiency
    Disease: Version SOC Term Classification Code Term Level
    12.1 10056438 Growth hormone deficiency LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) SE (Prematurely Ended) FI (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-001696-51 Sponsor Protocol Number: 25735 Start Date*: 2015-07-15
    Sponsor Name:Merck KGaA [...]
    1. Merck KGaA
    2. Merck Serono s.a.s.
    Full Title: Optimization of the Dosage Regimen With Growth Hormone Therapy in Children Born Small for Gestational Age. An Open Label, Randomized, Pilot Study, Comparing in Children Treated for 3 Years, the Eff...
    Medical condition: Small for Gestational Age (SGA)
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-000843-29 Sponsor Protocol Number: MS316 Start Date*: 2019-05-31
    Sponsor Name:Ipsen Pharma
    Full Title: Recombinant Human Growth Hormone (rhGH) and Recombinant Human Insulin-like Growth Factor-1 (rhIGF-1) Combination Therapy in Children with Short Stature Associated with IGF-1 Deficiency: A Six-year,...
    Medical condition: Idiopatic Short Stature in prepubertal children associated with low IGF-1 and normal stimulated GH response
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001708-69 Sponsor Protocol Number: 20184 Start Date*: 2015-07-15
    Sponsor Name:Merck KGaA
    Full Title: An Open Study of the Safety and Efficacy of Saizen®, (Recombinant Human Growth Hormone, r-hGH), in Children Born With Serious Intra-uterine Growth Retardation (IUGR) Treated to Final Height
    Medical condition: Children Born With Serious Intra-uterine Growth Retardation
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-004772-36 Sponsor Protocol Number: 38821 Start Date*: 2006-06-30
    Sponsor Name:NV Organon
    Full Title: Pregnancy and neonatal follow-up of ongoing pregnancies established after controlled ovarian stimulation in clinical trial 38819 for Org 36286 (corifollitropin alfa)
    Medical condition: Controlled Ovarian Stimulation (COS) to induce the development of multiple follicles in patients participating in an Assisted Reproductive Technology (ART) program
    Disease: Version SOC Term Classification Code Term Level
    7.1 10017399 LLT
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed) GB (Completed) SE (Completed) ES (Completed) BE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2006-004304-39 Sponsor Protocol Number: A6281283 Start Date*: 2008-03-12
    Sponsor Name:Pfizer Pharma GmbH
    Full Title: NEUROMUSCULAR CHANGES IN SMALL FOR GESTATIONAL AGE (SGA-) CHILDREN DURING SOMATROPIN THERAPY - A PROSPECTIVE, RANDOMIZED, CONTROLLED, OPEN-LABEL, MULTICENTER TRIAL (SGA-POWER STUDY)
    Medical condition: Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who faile...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10041093 Small for gestational age LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-001574-24 Sponsor Protocol Number: 13041970 Start Date*: 2006-10-06
    Sponsor Name:Radboud University Nijmegen Medical Centre, Department of Endocrinology
    Full Title: Visualisation of coronary arteries for the analysis of premature atherosclerosis in patients with adult-onset GH deficiency
    Medical condition: Patients with adult-onset growth hormone deficiency and the presence of atherosclerotic disease in the coronary arteries
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2017-002164-41 Sponsor Protocol Number: END-GH-2017 Start Date*: 2017-07-03
    Sponsor Name:Fundació Parc Taulí
    Full Title: Growth hormone therapy in adults with Prader-Willi syndrome: Effect on muscle tone assessed by functional magnetic resonance imaging (fMRI) and its relation to muscle strenght and body composition.
    Medical condition: Patients with Prader-Willi Syndrome (SPW) with Growth hormone deficit.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10036476 Prader-Willi syndrome PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-002228-34 Sponsor Protocol Number: 2012/1vas Start Date*: 2015-09-30
    Sponsor Name:Diego Caicedo Valdés
    Full Title: Growth hormone (GH) angiogenic effect clinical trial on patients with lower limb critical ischemia. GHAS Study
    Medical condition: Lower limb critical ischemia
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004866 10023034 Ischemia peripheral LLT
    18.0 100000004866 10058069 Critical limb ischemia LLT
    18.0 100000004866 10066920 Leg ischemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-003146-33 Sponsor Protocol Number: A6281265 Start Date*: Information not available in EudraCT
    Sponsor Name:Pfizer AB
    Full Title: INDIVIDUALIZED DOSE OF GENOTROPIN® (SOMATROPIN) TO SHORT PREPUBERTAL CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA): COMPARISON WITH FIXED DOSE TREATMENT IN EVALUATION OF GROWTH AND SAFETY IN AN OPE...
    Medical condition: TO SHORT PREPUBERTAL CHILDREN BORN SMALL FOR GESTATIONAL AGE
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-012089-30 Sponsor Protocol Number: UZB-PED-2009-001 Start Date*: 2010-03-19
    Sponsor Name:UZ Brussel
    Full Title: Frequency and mechanisms of resistance to IGF-1 generation in non-GH deficient short children with low IGF-1 concentration
    Medical condition: Prepubertal children with stature < -2 SDS, IGF-1 < the lowest reference limit and normal growth hormone response to an ITT or glucagon test
    Disease: Version SOC Term Classification Code Term Level
    9.1 10040600 Short stature LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-004904-19 Sponsor Protocol Number: 04_ENDO_44 Start Date*: 2005-07-11
    Sponsor Name:Christie Hospital
    Full Title: A two-centre, open label study of weekly pegvisomant treatment for patients with acromegaly
    Medical condition: This study will investigate the efficacy of once-weekly pegvisomant treatment in patients with acromegaly who have already achieved disease control on daily pegvisomant. The attraction of once wee...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-019850-42 Sponsor Protocol Number: ENB-010-10 Start Date*: 2011-03-04
    Sponsor Name:Alexion Pharma GmbH
    Full Title: An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfotase alfa (human recombinant tissue nonspecific alkaline phosphatase fusion protein) in Infants a...
    Medical condition: Hypophosphatasia is a rare inborn error of bone metabolism caused by inactivating mutations in the gene encoding the Tissue-nonspecific alkaline phosphatase isoenzyme. With deficiency of Tissue-...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10049933 Hypophosphatasia PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) IT (Completed) ES (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2014-004105-32 Sponsor Protocol Number: 307-MET-9002-052 Start Date*: 2015-04-01
    Sponsor Name:Pfizer Inc
    Full Title: Prevention of Retarded Growth by Early Treatment With Recombinant Human Growth Factor (Genotonorm) in Children With Systemic Forms of Chronic Juvenile Arthritis Receiving Long-Term Corticosteroid T...
    Medical condition: Juvenile idiopathic arthritis (JIA)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-003006-27 Sponsor Protocol Number: GEXGP24201 Start Date*: 2012-11-27
    Sponsor Name:Glycotope GmbH
    Full Title: A Phase II, Multicentre, Multinational, Randomised, Assessor-Blind Trial to Investigate the Efficacy and Safety of Various Dosages of FSH-GEX™ in Comparison With 150 IU Gonal-f® in Women Undergoing...
    Medical condition: women undergoing intracytoplasmatic sperm injection (ICSI) as part of assisted reproduction
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004872 10016398 Female infertility LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-004104-30 Sponsor Protocol Number: 307-MET-9002-0009 Start Date*: 2015-04-01
    Sponsor Name:Pharmacia & Upjohn S.A.
    Full Title: Treatment With Recombinant Human Growth Hormone (Genotonorm) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety
    Medical condition: Juvenile idiopathic arthritis (JIA) and nephrotic syndrome (NeS)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-006465-16 Sponsor Protocol Number: rhGH in MS Start Date*: Information not available in EudraCT
    Sponsor Name:University of Leipzig
    Full Title: Pilot trial of recombinant human growth hormone for remyelination in multiple sclerosis
    Medical condition: Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063399 Relapsing-remitting multiple sclerosis LLT
    9.1 10063400 Secondary progressive multiple sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    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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