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Clinical trials for Recombinant gene

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   44336   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    144 result(s) found for: Recombinant gene. Displaying page 1 of 8.
    1  2  3  4  5  6  7  8  Next»
    EudraCT Number: 2022-002310-16 Sponsor Protocol Number: LHinPOR001 Start Date*: 2023-02-01
    Sponsor Name:UZ Brussel
    Full Title: Endometrial gene expression profiles during ovarian stimulation with recombinant human FSH with or without the addition of recombinant human LH in genuine poor responders.
    Medical condition: Infertility
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    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: 2014-000126-38 Sponsor Protocol Number: OVG2012/05 Start Date*: 2014-04-08
    Sponsor Name:University of Oxford
    Full Title: Towards improved meningococcal vaccines: a randomised, descriptive, open label study exploring the relationship between gene expression signatures with reactogenicity and immunogenicity following v...
    Medical condition: This study aims to investigate gene expression following vaccination with 4CMenB and relate this to vaccine reactions and to immune response
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-003779-31 Sponsor Protocol Number: BER-FSH-2015-01 Start Date*: 2015-12-04
    Sponsor Name:INSTITUTO BERNABEU
    Full Title: Prospective, Randomized Open Trial to Evaluate the Efficacy of Highly Purified Urinary FSH (Fostipur®, IBSA) versus Recombinant FSH (Bemfola® Finox) in Oocyte Donors Undergoing Controlled Ovarian S...
    Medical condition: Ovarian stimulation for oocyte donation.
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004872 10021940 Infertility, female, of unspecified origin LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002290-35 Sponsor Protocol Number: MGT006 Start Date*: 2016-12-20
    Sponsor Name:MeiraGTx UK II Limited
    Full Title: An open label, multi-centre, Phase I/II dose escalation trial of a recombinant adeno-associated virus vector (AAV2/8-hCARp.hCNGB3) for gene therapy of adults and children with achromatopsia owing t...
    Medical condition: Achromatopsia caused by mutations in the CNGB3 gene
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000454 Achromatopsia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-009429-26 Sponsor Protocol Number: local 997 (P06034) Start Date*: 2010-03-15
    Sponsor Name:FREE UNIVERSITY OF BRUSSELS
    Full Title: A PILOT STUDY TO EVALUATE THE EFFECT OF TRIGGERING FINAL OOCYTE MATURATION WITH GnRHa OR hCG ON ENDOMETRIAL RECEPTIVITY PARAMETERS AND THE LUTEAL PHASE IN OOCYTE DONORS
    Medical condition: Compare the endometrium of oocyte donors, who had final oocyte maturation with either hCG, Suprefact, followed by hCG 35 hours after triggering, Suprefact or Suprefact without luteal phase support....
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2007-007165-20 Sponsor Protocol Number: rhASA-04 Start Date*: 2008-02-26
    Sponsor Name:Shire Pharmaceuticals Ireland Limited
    Full Title: A single center, open-label, non-randomized, uncontrolled, multiple-dose study of the efficacy and safety of Metazym (recombinant human arylsulfatase A or rhASA) for the treatment of MLD patients w...
    Medical condition: Metachromatic Leukodystrophy (MLD) in late infantile patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10024381 Leukodystrophy LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2005-002829-31 Sponsor Protocol Number: AGLU02804, Amendment 1 Start Date*: 2005-08-31
    Sponsor Name:Genzyme Europe BV
    Full Title: Full title of the trial : A Single Centre, Open-Label, Bridging Study of the Safety, Pharmacokinetics and Efficacy of Recombinant Human Acid Alpha-Glucosidase (rhGAA) Treatment in Patients with Lat...
    Medical condition: Glycogen Storage Disease type II (Pompe´s disease)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-010736-18 Sponsor Protocol Number: C1 1207 Start Date*: 2009-05-04
    Sponsor Name:Pharming Technologies B.V.
    Full Title: An open-label exploratory Phase II study of the safety and prophylactic effect of a weekly 50 U/kg rC1INH treatment in asymptomatic patients with hereditary C1INH deficiency (HAE)
    Medical condition: Explore the effect of rC1INH in patients with HAE in preventing the occurence of acute HAE attacks.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2014-005477-37 Sponsor Protocol Number: 261303 Start Date*: 2016-01-26
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: Phase 3, prospective, randomized, multi-center clinical study comparing the safety and efficacy of BAX 855 following PK-guided prophylaxis targeting two different FVIII trough levels in subjects wi...
    Medical condition: Severe hemophilia A (FVIII <1%)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) AT (Completed) SE (Completed) CZ (Prematurely Ended) ES (Completed) HU (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    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: 2016-003856-59 Sponsor Protocol Number: MGT007 Start Date*: 2017-04-12
    Sponsor Name:MeiraGTX UK II Ltd
    Full Title: Long-term follow-up study of participants following an open label, multi-centre, Phase I/II dose escalation trial of a recombinant adeno-associated virus vector (AAV2/8-hCARp.hCNGB3) for gene thera...
    Medical condition: Achromatopsia caused by mutations in the CNGB3 gene
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10000454 Achromatopsia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-003967-21 Sponsor Protocol Number: MGT009 Start Date*: 2017-06-09
    Sponsor Name:MeiraGTx UK II Limited
    Full Title: An open label, multi-centre, Phase I/II dose escalation trial of a recombinant adeno-associated virus vector (AAV2/5-hRKp.RPGR) for gene therapy of adults and children with X-linked Retinitis Pigme...
    Medical condition: X-Linked Retinitis Pigmentosa caused by mutations in the RPGR gene
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10038914 Retinitis pigmentosa PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-005203-18 Sponsor Protocol Number: 110551 Start Date*: 2008-06-24
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open Phase II study of immunization with the recMAGE-A3 + AS01B Antigen-Specific Cancer Immunotherapeutic in patients with MAGE-A3-positive unresectable and progressive metastatic cutaneous mela...
    Medical condition: MAGE-A3-positive unresectable and progressive metastatic cutaneous melanoma.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Prematurely Ended)
    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: 2004-000622-67 Sponsor Protocol Number: 3147K2-101WW Start Date*: 2005-06-03
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: A Double-Blind, Placebo-Controlled, Randomized, Multiple Ascending Dose, Safety Study of MYO-029 Administered to Adult Patients with Becker, Facioscapulohumeral and Limb-Girdle Muscular Dystrophy.
    Medical condition: Becker Muscular Dystrophy, Facioscapulohumeral Muscular Dystrophy, Limb-Girdle Muscular Dystrophy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-009369-32 Sponsor Protocol Number: ENB-003-08 Start Date*: 2009-03-30
    Sponsor Name:Alexion Pharma GmbH
    Full Title: Extension Study of ENB-0040 (Human Recombinant Tissue-Nonspecific Alkaline Phosphatase Fusion Protein) in Severely Affected Infants and Young Children with Hypophosphatasia (HPP)
    Medical condition: Infantile hypoposphatasia
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10049933 Hypophosphatasia PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-004007-64 Sponsor Protocol Number: 111476 Start Date*: 2009-07-16
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma
    Medical condition: First-line treatment for patients with unresectable, MAGE-A3-positive stage III or stage IVa melanoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) IE (Completed) FR (Completed) ES (Completed) IT (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2008-002447-16 Sponsor Protocol Number: 111482 Start Date*: 2008-11-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 ASCI as adjuvant therapy in patients with MAGE-A3 positive resected stage III melanoma
    Medical condition: Patients with histologically proven stage IIIB or IIIC cutaneous melanoma with macroscopic lymph node involvement suitable for surgical resection. Macroscopic lymph node involvement is defined as c...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025670 Malignant melanoma stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) DE (Prematurely Ended) BE (Completed) CZ (Prematurely Ended) FR (Completed) NL (Prematurely Ended) IT (Prematurely Ended) SE (Prematurely Ended) EE (Prematurely Ended) ES (Completed) AT (Prematurely Ended) GR (Prematurely Ended) BG (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-000706-21 Sponsor Protocol Number: AT-GTX-501-02 Start Date*: 2021-12-10
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: LONG-TERM FOLLOW-UP OF AT-GTX-501 SCAAV9 GENE TRANSFER IN SUBJECTS WITH CLN6 BATTEN DISEASE
    Medical condition: Patients with variant late infantile neuronal ceroid lipofuscinosis associated with mutation(s) in the CLN6 gene (vLINCL6 disease), a subset of patients with CLN6 Batten disease.
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004850 10052074 Neuronal ceroid lipofuscinosis NOS LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    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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