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Clinical trials for gene therapy

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   44393   clinical trials with a EudraCT protocol, of which   7405   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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    1,407 result(s) found for: gene therapy. Displaying page 8 of 71.
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    EudraCT Number: 2016-001446-25 Sponsor Protocol Number: FHGT002 Start Date*: 2017-09-20
    Sponsor Name:University of Pennsylvania
    Full Title: AAV8-mediated Low Density Lipoprotein Receptor (LDLR) Gene Replacement in Subjects with Homozygous Familial Hypercholesterolemia (HoFH)
    Medical condition: Adults with homozygous familial hypercholesterolemia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004630-42 Sponsor Protocol Number: TAS-120-301 Start Date*: 2021-01-25
    Sponsor Name:Taiho Oncology Inc
    Full Title: A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangem...
    Medical condition: Advanced solid tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) PT (Prematurely Ended) DE (Prematurely Ended) PL (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-006381-29 Sponsor Protocol Number: EXPRESSION Start Date*: 2009-11-12
    Sponsor Name:Universitätsmedizin Mainz
    Full Title: Neoadjuvant, sequential chemotherapy with docetaxel followed by Fluorouracil, Epirubicin, and Cyclophosphamid every 3 weeks - genome wide expression analysis for identification of a predictive gene...
    Medical condition: Eligible will be only females between 18 - 70 years of age, suffering from histologically confirmed primary breast cancer, nodal status positive or negative, phase cT2, cT3, or cT4 including inflam...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006201 Breast cancer stage III PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10021974 Inflammatory breast cancer LLT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006202 Breast cancer stage IV PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006200 Breast cancer stage II PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002096-18 Sponsor Protocol Number: B2151007 Start Date*: 2014-08-13
    Sponsor Name:Pfizer Inc.,235 East 42nd Street, New York, NY 10017
    Full Title: AN OPEN-LABEL, MULTI-CENTER, RANDOMIZED PHASE 1B/2 STUDY OF PF05212384 PLUS 5-FLUOROURACIL-LEUCOVORIN-IRINOTECAN (FOLFIRI) VERSUS BEVACIZUMAB PLUS FOLFIRI IN METASTATIC COLORECTAL CANCER
    Medical condition: Metastatic Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IT (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-003098-26 Sponsor Protocol Number: 3144A1-201-WW Start Date*: 2006-06-06
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: Phase 2 Study of HKI-272 in Subjects with Advanced Breast Cancer
    Medical condition: Breast cancer is the most frequently diagnosed malignancy and the second most common cause of cancer related deaths in women. HER2 is a member of the epidermal growth factor receptor (EGFR) family ...
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-003418-25 Sponsor Protocol Number: CTU/2014/120 Start Date*: 2016-03-29
    Sponsor Name:MeiraGTx UK II Ltd
    Full Title: An Open-label, Multi-centre, Phase I/II Dose Escalation Trial of an Adeno-Associated Virus Vector (AAV2/5-OPTIRPE65) for Gene Therapy of Adults and Children with Retinal Dystrophy associated with D...
    Medical condition: Leber Congenital Amaurosis (LCA) caused by mutations in RPE65
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10070667 Leber's congenital amaurosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-000878-11 Sponsor Protocol Number: OMO1.01.02 Start Date*: 2017-06-08
    Sponsor Name:OCTIMET Oncology NV
    Full Title: A modular, multi-arm, multi-part, first time in patient study to evaluate the safety and tolerability of OMO-1, alone and in combination with anti-cancer treatments, in patients with locally advanc...
    Medical condition: Locally advanced, unresectable or metastatic solid malignancies
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065143 Malignant solid tumour LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) NL (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-000673-38 Sponsor Protocol Number: EGF111438 Start Date*: Information not available in EudraCT
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib plus Capecitabine versus Trastuzumab plus Capecitabine in Patients with Anthracycline- or Taxane-Exposed ErbB2-Positive Metastati...
    Medical condition: Metastatic breast cancer overexpressing ErbB2
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006202 Breast cancer stage IV PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) FR (Completed) ES (Prematurely Ended) BE (Prematurely Ended) IT (Prematurely Ended) SE (Completed) DK (Prematurely Ended) HU (Completed) GB (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2006-000564-81 Sponsor Protocol Number: EGF106903 Start Date*: 2008-01-14
    Sponsor Name:GlaxoSmithKline Research and Development Limited
    Full Title: A randomised, multicentre, open-label, phase III study of neoadjuvant lapatinib, trastuzumab, and their combination plus paclitaxel in women with HER2/ErbB2 positive primary breast cancer
    Medical condition: Women with primary ErbB2 overexpressing and/or gene amplified breast cancer > 2 cm diameter who have not undergone previous treatment for invasive breast cancer
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057654 Breast cancer female LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Completed) DE (Completed) BE (Completed) GB (Completed) LT (Completed) GR (Prematurely Ended) HU (Completed) ES (Completed) IT (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2019-000657-31 Sponsor Protocol Number: EMCR2015-7741 Start Date*: 2019-09-05
    Sponsor Name:Erasmus MC Cancer Institute
    Full Title: Adoptive therapy with TCR gene-engineered T cells to treat patients with MAGE-C2-positive melanoma and head and neck cancer.
    Medical condition: unresectable stage IIIc and IV melanoma (including unknown primary, mucosal and uveal melanoma), and unresectable recurrent/metastatic(R/M) HNSCC.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025670 Malignant melanoma stage III PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10071536 Head and neck cancer stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10071540 Head and neck cancer metastatic PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025671 Malignant melanoma stage IV PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-005437-53 Sponsor Protocol Number: ITCC053 Start Date*: 2016-11-03
    Sponsor Name:Erasmus Medical Center
    Full Title: A phase 1B of crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignancies Study ITCC 053
    Medical condition: Malignancies carrying a genetic alteration of ALK, MET or ROS1
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) DE (Trial now transitioned) IE (Completed) ES (Ongoing) DK (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003612-45 Sponsor Protocol Number: A9001502 Start Date*: 2019-09-06
    Sponsor Name:Pfizer Inc.
    Full Title: TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)
    Medical condition: Cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000206-28 Sponsor Protocol Number: SB-318-1502 Start Date*: 2018-08-14
    Sponsor Name:Sangamo Therapeutics, Inc.
    Full Title: A Phase 1/2, Multicenter, Open-Label, Single-Dose, Dose-Ranging Study to Assess the Safety and Tolerability of SB-318, a rAAV2/6-based Gene Transfer in Subjects with Mucopolysaccharidosis I (MPS I)
    Medical condition: Mucopolysaccharidosis type I (MPS I)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056886 Mucopolysaccharidosis I PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-000192-33 Sponsor Protocol Number: SB-913-1602 Start Date*: 2018-08-17
    Sponsor Name:Sangamo Therapeutics, Inc.
    Full Title: A Phase 1/2, Multicenter, Open-label, Single-dose, Dose-ranging Study to Assess the Safety and Tolerability of SB-913, a rAAV2/6-based Gene Transfer in Subjects with Mucopolysaccharidosis II (MPS II)
    Medical condition: Mucopolysaccharidosis type II (MPS II)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2008-005667-34 Sponsor Protocol Number: G0701625 Start Date*: 2009-01-16
    Sponsor Name:University of Edinburgh [...]
    1. University of Edinburgh
    2. NHS Lothian
    Full Title: Randomised Trial of Genetic Testing and Targeted Zoledronic acid therapy to Prevent SQSTM1 Mediated Paget's Disease (Zoledronate in the Prevention of Paget's).
    Medical condition: Paget's disease of the bone (PDB)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004859 10033363 Paget's disease of bone LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) IT (Completed) IE (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2006-000176-32 Sponsor Protocol Number: CGX-635-CML-202 Start Date*: 2006-09-22
    Sponsor Name:Stragen France
    Full Title: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine) (CGX-635) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) with the T315I BCR-ABL G...
    Medical condition: Chronic Myeloid Leukaemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-006032-22 Sponsor Protocol Number: 41829447 (ISRCTN No) Start Date*: 2007-04-04
    Sponsor Name:University of Manchester [...]
    1. University of Manchester
    2. Dudley Group of Hospitals NHS Trust
    Full Title: TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis
    Medical condition: Rheumatoid arthritis is associated with increased mortality from cardiovascular disease (CVD). Statins have a proven effect in reducing CVD events in at-risk populations, mostly due to their chole...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-000981-41 Sponsor Protocol Number: TUXEDO-1 Start Date*: 2020-06-26
    Sponsor Name:Med. Univ. Wien, Klinik f. Innere Mdizin I, Onkologie
    Full Title: Phase II Study of Trastuzumab-Deruxtecan (T-DX; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases
    Medical condition: HER2-positive Breast Cancer with newly diagnosed or progressing Brain Metastases
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001205-73 Sponsor Protocol Number: IMP4297-202 Start Date*: 2021-08-24
    Sponsor Name:IMPACT Therapeutics, Inc.
    Full Title: A Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Phase II Study to Evaluate Senaparib Maintenance in mCRPC Patients with Homologous Recombination Repair Gene Alterations after Docetax...
    Medical condition: metastatic castration-resistant prostate cancer (mCRPC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Completed) FR (Completed) ES (Ongoing) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-000185-22 Sponsor Protocol Number: 20110265 Start Date*: 2014-12-03
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 1b/2, Multicenter, Open-label Trial of Talimogene Laherparepvec in Combination With MK-3475 for Treatment of Previously Untreated, Unresected, Stage IIIB to IVM1c Melanoma
    Medical condition: Previously Untreated, Unresected, Stage IIIB to IVM1c Melanoma
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10053571 Melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) ES (Prematurely Ended) BE (Completed) DE (Prematurely Ended) AT (Prematurely Ended) GR (Completed) IT (Prematurely Ended) FI (Prematurely Ended) CZ (Completed) PT (Completed) HU (Prematurely Ended)
    Trial results: View results
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    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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