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Clinical trials for Gene products

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   44335   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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    313 result(s) found for: Gene products. Displaying page 1 of 16.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2019-002113-19 Sponsor Protocol Number: 42756493CAN2002 Start Date*: 2019-10-31
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumors and FGFR Gene Alterations
    Medical condition: Advanced solid tumors (other than Urothelial tumors), and FGFR gene alterations.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065143 Malignant solid tumour LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) PL (Completed) FR (Completed) DE (Trial now transitioned) ES (Ongoing) BE (Completed) IT (Completed) Outside EU/EEA SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-002343-14 Sponsor Protocol Number: RAG1-2019-01 Start Date*: 2020-09-25
    Sponsor Name:Leiden University Medical Center
    Full Title: PHASE I/II CLINICAL TRIAL OF AUTOLOGOUS HEMATOPOIETIC STEM CELL GENE THERAPY FOR RAG1-DEFICIENT SEVERE COMBINED IMMUNODEFICIENCY
    Medical condition: Patients with severe combined immunodeficiency (SCID) based on a genetic defect in the Recombinase Activating Gene 1 (RAG1)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-004024-11 Sponsor Protocol Number: SHP648-101 Start Date*: 2020-05-04
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: An Open-Label, Multinational, Phase 1/2 Study of the Safety and Dose Escalation of SHP648, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing FIX Padua in Hemophilia B Subjects
    Medical condition: Hemophilia B is a X-linked recessive bleeding disorder caused by mutations in the gene encoding clotting factor IX (FIX) that result in disruption of the normal clotting pathway. Hemophilia B affec...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended) HU (Prematurely Ended) ES (Prematurely Ended) AT (Prematurely Ended) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002245-11 Sponsor Protocol Number: LTF-303 Start Date*: 2013-11-12
    Sponsor Name:bluebird bio, Inc.
    Full Title: Long-term Follow-up of Subjects Treated with Ex Vivo Gene Therapy using Autologous Hematopoietic Stem Cells Transduced with a Lentiviral Vector
    Medical condition: Subjects treated with gene therapy drug products in a bluebird bio-sponsored or associated clinical study will be invited to participate in this long-term follow-up study to monitor the safety and ...
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004850 10055579 Sickle-cell beta thalassemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) GB (GB - no longer in EU/EEA) GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004266-18 Sponsor Protocol Number: LTF-307 Start Date*: 2020-09-03
    Sponsor Name:bluebird bio, Inc.
    Full Title: Long-term Follow-up of Subjects With Sickle Cell Disease Treated With Ex Vivo Gene Therapy Using Autologous Hematopoietic Stem Cells Transduced With a Lentiviral Vector
    Medical condition: Subjects with sickle-cell disease treated with gene therapy drug products in a bluebird bio-sponsored study will be invited to participate in this long-term follow-up study to monitor the safety an...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10040648 Sickle cell SC disease LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002209-25 Sponsor Protocol Number: 67652000PCR3002 Start Date*: 2020-10-12
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Parti...
    Medical condition: Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
    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
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned) DE (Ongoing) PT (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003895-65 Sponsor Protocol Number: DAL-301 Start Date*: 2016-06-22
    Sponsor Name:DalCor Pharma UK Ltd, Leatherhead, Swiss Branch Zug
    Full Title: A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Sy...
    Medical condition: This study is investigating the cardiovascular morbidity and mortality (cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction (MI) and non-fatal stroke) in subjects wit...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10051592 Acute coronary syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed) SE (Completed) SK (Completed) DK (Completed) FI (Completed) PT (Completed) DE (Completed) HU (Completed) ES (Ongoing) AT (Completed) CZ (Completed) BG (Completed) RO (Ongoing) PL (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-002443-26 Sponsor Protocol Number: OVG2012/04 Start Date*: 2012-08-17
    Sponsor Name:University of Oxford
    Full Title: A phase II, multi-centre, open labelled randomised control trial to describe immune & transcriptomic responses to trivalent inactivated vaccine (TIV) & MF59 adjuvanted influenza vaccine (ATIV) in 1...
    Medical condition: Healthy children will be immunised with two vaccines against influenza: Agrippal or Imuvac, or Fluad to study the immune responses to immunisation at a genetic level.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-002432-17 Sponsor Protocol Number: ALN-AS1-003 Start Date*: 2017-11-22
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: ENVISION: A Phase 3 Randomized, Double-blind, Placebo-controlled Multicenter Study with an Open-label Extension to Evaluate the Efficacy and Safety of Givosiran in Patients with Acute Hepatic Porph...
    Medical condition: Acute Hepatic Porphyrias (AHP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10036182 Porphyria acute PT
    20.0 10010331 - Congenital, familial and genetic disorders 10036184 Porphyria hepatic LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Completed) DK (Completed) CZ (Completed) SE (Completed) BG (Completed) FI (Completed) BE (Completed) FR (Completed) PL (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-005711-17 Sponsor Protocol Number: AGT4HB Start Date*: 2009-09-25
    Sponsor Name:St. Jude Children’s Research Hospital
    Full Title: AN OPEN LABEL DOSE-ESCALATION STUDY OF A SELF COMPLEMENTARY ADENO-ASSOCIATED VIRAL VECTOR (scAAV2/8-LP1-hFIXco) FOR GENE TRANSFER IN SUBJECTS WITH HEMOPHILIA B
    Medical condition: Gene therapy for Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10001140 Adeno-associated in vivo gene therapy LLT
    19.0 10010331 - Congenital, familial and genetic disorders 10061992 Haemophilia PT
    Population Age: Adults Gender: Male
    Trial protocol: GB (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2009-012504-13 Sponsor Protocol Number: A8081005 Start Date*: 2010-01-20
    Sponsor Name:Pfizer Inc 235 East 42nd Street, New York, NY10017
    Full Title: PHASE 2, OPEN-LABEL SINGLE ARM STUDY OF THE EFFICACY AND SAFETY OF PF 02341066 IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION INVOLVING THE ANAP...
    Medical condition: metastatic non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    15.1 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: GB (Completed) NL (Completed) DE (Completed) ES (Completed) HU (Completed) PL (Completed) GR (Completed) IT (Completed) FR (Completed) IE (Completed) BG (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004846-31 Sponsor Protocol Number: 386022010017 Start Date*: 2017-12-14
    Sponsor Name:University medical centre Maribor
    Full Title: Impact of vitamin D supplementation in patients with multiple sclerosis
    Medical condition: Relapsing remitting multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004852 10064137 Progression of multiple sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001057-40 Sponsor Protocol Number: 301OTC01 Start Date*: 2017-03-14
    Sponsor Name:Ultragenyx Pharmaceutical, Inc.
    Full Title: A Phase 1/2, Open-Label Safety and Dose-Finding Study of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults with Late-Onset OT...
    Medical condition: Ornithine transcarbamylase deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10071107 Ornithine transcarbamylase deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-012595-27 Sponsor Protocol Number: A8081007 Start Date*: 2010-01-20
    Sponsor Name:Pfizer Inc. 235 East 42nd Street, New York, NY 10017
    Full Title: PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF PF 02341066 VERSUS STANDARD OF CARE CHEMOTHERAPY (PEMETREXED OR DOCETAXEL) IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (...
    Medical condition: ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS
    Disease: Version SOC Term Classification Code Term Level
    17.1 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: GB (Completed) NL (Completed) DE (Completed) PL (Completed) ES (Completed) HU (Completed) FR (Completed) GR (Completed) IT (Completed) IE (Completed) BG (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004534-23 Sponsor Protocol Number: GATRA2016 Start Date*: 2017-04-11
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    Full Title: Pilot study of Antithrombin supplementation during Extracorporeal Membrane Oxigenation
    Medical condition: Adult patients requiring veno-venous Extracorporeal circulation (ECMO) as a support for respiratory failure
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038651 Respiration failure LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10001053 Acute respiratory failure PT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10060842 Hypercapnic respiratory failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-000418-75 Sponsor Protocol Number: TV5600-CNS-20007 Start Date*: 2014-11-18
    Sponsor Name:Teva Branded Pharmaceutical Products R&D, Inc.
    Full Title: A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients...
    Medical condition: Huntington's Disease (HD)
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10070668 Huntington's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed) GB (Completed) CZ (Completed) DE (Completed) PT (Completed) NL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-003616-13 Sponsor Protocol Number: TPX-0005-01 Start Date*: 2020-05-12
    Sponsor Name:Turning Point Therapeutics, Inc.
    Full Title: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ...
    Medical condition: advanced solid tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) DE (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) HU (Trial now transitioned) DK (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001461-36 Sponsor Protocol Number: CT-AMT-130-02 Start Date*: 2021-06-30
    Sponsor Name:uniQure biopharma B.V.
    Full Title: A Phase Ib/II Randomised, Double-Blind Study to Explore Safety, Tolerability, and Efficacy Signals of Multiple Doses of Striatally-Administered rAAV5-miHTT Total Huntingtin Gene (HTT) Lowering Ther...
    Medical condition: Huntington Disease
    Disease: Version SOC Term Classification Code Term Level
    27.1 10010331 - Congenital, familial and genetic disorders 10070668 Huntington's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-003385-84 Sponsor Protocol Number: GO40782(RXDX-101-02) Start Date*: 2016-03-15
    Sponsor Name:F. Hoffman-La Roche Ltf
    Full Title: AN OPEN-LABEL, MULTICENTER, GLOBAL PHASE 2 BASKET STUDY OF ENTRECTINIB FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS THAT HARBOR NTRK1/2/3, ROS1, OR ALK GENE REARRA...
    Medical condition: Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-019577-16 Sponsor Protocol Number: EGF114299 Start Date*: 2010-12-21
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase III trial to compare the safety and efficacy of lapatinib plus trastuzumab plus an aromatase inhibitor (AI) versus trastuzumab plus an AI versus lapatinib plus an AI as first- or second-lin...
    Medical condition: HER2-positive metastatic breast cancer who have received prior trastuzumab and endocrine therapies
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Prematurely Ended) HU (Completed) IE (Prematurely Ended) PL (Completed) BE (Completed) BG (Prematurely Ended) NO (Prematurely Ended) GB (Completed) LT (Prematurely Ended) PT (Prematurely Ended) ES (Ongoing) GR (Completed) IT (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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