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Clinical trials for Gene Insertion

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   43893   clinical trials with a EudraCT protocol, of which   7300   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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    20 result(s) found for: Gene Insertion. Displaying page 1 of 1.
    EudraCT Number: 2017-001731-39 Sponsor Protocol Number: STRIM002-(205813) Start Date*: 2017-10-12
    Sponsor Name:Orchard Therapeutics (Europe) Ltd
    Full Title: Methodology study to investigate the utility of retroviral insertion site analysis in samples from subjects treated with Strimvelis™ gene therapy
    Medical condition: Adenosine deaminase (ADA) deficiency severe combined immunodeficiency
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10066367 Adenosine deaminase deficiency LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-005492-12 Sponsor Protocol Number: BDTX-189-01 Start Date*: 2021-05-27
    Sponsor Name:Black Diamond Therapeutics, Inc.
    Full Title: MasterKey-01: A Phase 1/2, Open-label, Two-part, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB Mutation...
    Medical condition: NSCLC, breast cancer, biliary tract cancer, or cervical cancer, any other solid tumors with specific gene mutations
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) NL (Prematurely Ended) ES (Completed) IT (Prematurely Ended) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-003506-11 Sponsor Protocol Number: IFCT-1703 Start Date*: 2019-01-23
    Sponsor Name:IFCT
    Full Title: Phase II trial of trastuzumab in combination with pertuzumab in pretreated patients with non-small cell lung cancer (NSCLC) harboring a Her2 mutation and receiving docetaxel
    Medical condition: Non small cell lung cancer with a Her2 mutation
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029519 Non-small cell lung cancer stage III PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    23.0 10010331 - Congenital, familial and genetic disorders 10075653 HER2 gene amplification PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    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: 2008-004849-28 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: 2012-003427-38 Sponsor Protocol Number: HGT-GCB-068 Start Date*: 2016-04-07
    Sponsor Name:Shire Human Genetic Therapies
    Full Title: A Multi-center, Open-label, Efficacy and Safety Study of Velaglucerase Alfa Enzyme Replacement Therapy in Children and Adolescents With Type 3 Gaucher Disease
    Medical condition: Type 3 Gaucher disease
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10075697 Gaucher's disease type I PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-004734-15 Sponsor Protocol Number: EBio Start Date*: 2019-06-03
    Sponsor Name:Universitätsklinikum Erlangen
    Full Title: EBIO – Enthesitis biopsy study
    Medical condition: Psoriatic arthritis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002680-26 Sponsor Protocol Number: RP-L201-0218 Start Date*: 2018-11-27
    Sponsor Name:Rocket Pharmaceuticals, Inc.
    Full Title: Gene Therapy for Leukocyte Adhesion Deficiency-I (LAD-I): A Phase I Clinical Trial to Evaluate the Safety and Efficacy of the Infusion of Autologous Hematopoietic Stem Cells Transduced with a Lenti...
    Medical condition: Leukocyte Adhesion Deficiency-I (LAD-I)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018137 Genetic anomalies of leukocytes LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-001965-27 Sponsor Protocol Number: HGT-GCB-044 Start Date*: 2008-10-29
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: An Open-Label Extension Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients with Type 1 Gaucher Disease
    Medical condition: Type I Gaucher disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018048 Gaucher's disease LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-002636-82 Sponsor Protocol Number: OTL-200-07 Start Date*: 2019-12-02
    Sponsor Name:Orchard Therapeutics (Europe) Limited
    Full Title: An open label, non-randomised trial to evaluate the safety and efficacy of a single infusion of OTL-200 in patients with Late Juvenile (LJ) Metachromatic Leukodystrophy (MLD)
    Medical condition: Metachromatic Leukodystrophy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10067609 Metachromatic leukodystrophy PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000737-39 Sponsor Protocol Number: AD04-301 Start Date*: 2020-04-28
    Sponsor Name:Adial Pharmaceuticals Inc.
    Full Title: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Tolerability of AD04 (Ondansetron) in Adults with A...
    Medical condition: Adult patients diagnosed with moderate or severe alcohol use disorder
    Disease: Version SOC Term Classification Code Term Level
    20.1 10037175 - Psychiatric disorders 10080021 Alcohol use disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed) BG (Completed) PL (Completed) EE (Completed) LV (Completed) HR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-006304-11 Sponsor Protocol Number: TKT034 Start Date*: 2007-07-03
    Sponsor Name:Shire Human Genetic Therapies Inc
    Full Title: A multicenter open-label study of Gene-Activated Human Glucocerebrosidase (GA-GCB) enzyme replacement therapy in patients with type 1 Gaucher disease previously treated wiht imiglucerase
    Medical condition: Type I Gaucher Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018048 Gaucher's disease LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-000700-38 Sponsor Protocol Number: TEM-LT Start Date*: 2021-07-12
    Sponsor Name:GENENTA SCIENCE SRL
    Full Title: A follow-up study evaluating the long term safety of autologous CD34+-enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human interferon-a2 gene...
    Medical condition: Glioblastoma multiforme (GBM)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018337 Glioblastoma multiforme PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018337 Glioblastoma multiforme PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000814-23 Sponsor Protocol Number: CLDK378A2407 Start Date*: 2015-10-26
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A Phase II, open label, multi-center, multi-arm study of ceritinib in patients with advanced solid tumors and hematological malignancies characterized by genetic abnormalities of anaplastic lymphom...
    Medical condition: Advanced solid tumors and hematological malignancies with ALK genetic alteration and/or overexpression
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Temporarily Halted) CZ (Completed) FR (Prematurely Ended) DK (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-002323-35 Sponsor Protocol Number: TAK-669-3001 Start Date*: 2022-11-10
    Sponsor Name: Takeda Development Center Americas, Inc.
    Full Title: A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Velaglucerase Alfa in Chinese Subjects With Type 1 Gaucher Disease
    Medical condition: Type 1 Gaucher Disease
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2007-002840-21 Sponsor Protocol Number: HGT-GCB-039 Start Date*: 2007-10-30
    Sponsor Name:Shire Human Genetic Therapies Inc
    Full Title: A Multicenter, Randomized, Double-Blind, Parallel-Group Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy Compared with Imiglucerase in Patients with Type I Gauc...
    Medical condition: Type I Gaucher disease Enfermedad de Gaucher tipo 1
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018048 Gaucher's disease LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-002049-13 Sponsor Protocol Number: 843 Start Date*: 2013-11-29
    Sponsor Name:Oulu University Hospital
    Full Title: Erlotinib treatment beyond progression in EGFR mutant or patients who have responded to EGFR TKI in stage IIIB/IV NSCLC
    Medical condition: Locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor or who have responded to EGFR TKI
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10025054 Lung cancer non-small cell stage IIIB LLT
    14.1 100000004864 10025055 Lung cancer non-small cell stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2013-005532-23 Sponsor Protocol Number: CO-1686-019 Start Date*: Information not available in EudraCT
    Sponsor Name:Clovis Oncology, Inc.
    Full Title: TIGER-2: A Phase 2, Open-Label, Multicenter, Safety and Efficacy Study of Oral CO 1686 as 2nd Line EGFR-Directed TKI in Patients with Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)
    Medical condition: Previously treated NSCLC patients who have documented evidence of an activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10029514 Non-small cell lung cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-002077-21 Sponsor Protocol Number: ICR-CTSU/2017/10065 Start Date*: 2019-04-18
    Sponsor Name:The Institute of Cancer Research
    Full Title: PHOENIX Trial: A pre-surgical window of opportunity and post-surgical adjuvant biomarker study of DNA damage response inhibition and/or anti-PD-L1 immunotherapy in patients with neoadjuvant chemoth...
    Medical condition: Triple Negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-003974-29 Sponsor Protocol Number: D6186C00001 Start Date*: 2019-08-15
    Sponsor Name:AstraZeneca AB
    Full Title: A Biomarker-Directed Phase 2 Platform Study in Patients with Advanced Non-Small Cell Lung Cancer whose Disease has Progressed on First-Line Osimertinib Therapy
    Medical condition: Advanced Non-Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing) NO (Ongoing) DK (Completed) ES (Ongoing) NL (Ongoing) IT (Ongoing)
    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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