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Clinical trials for Gene duplication

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 ).  
     
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    17 result(s) found for: Gene duplication. Displaying page 1 of 1.
    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: 2016-004262-26 Sponsor Protocol Number: VBP15-002 Start Date*: 2017-02-13
    Sponsor Name:ReveraGen BioPharma Inc.
    Full Title: A Phase IIa, Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Vamorolone in Boys with Duchenne Muscular ...
    Medical condition: Duchenne Muscular Dystrophy (DMD)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: SE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-004901-29 Sponsor Protocol Number: NBK154/1/2020 Start Date*: 2021-06-01
    Sponsor Name:Medical University of Gdańsk
    Full Title: The efficacy and safety of Metoprolol as add-on treatment to standard of care in preventing cardiomyopathy in patients with Duchenne Muscular Dystrophy aged 8-17 years. A randomized, double-blind, ...
    Medical condition: Duchenne muscular dystrophy Cardiomyopathy Tachycardia
    Disease: Version SOC Term Classification Code Term Level
    27.1 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000844-31 Sponsor Protocol Number: VBP15-BMD-001 Start Date*: 2023-05-18
    Sponsor Name:ReveraGen BioPharma Inc.
    Full Title: A Phase II Pilot Trial of Vamorolone vs. Placebo for the Treatment of Becker Muscular Dystrophy
    Medical condition: Becker Muscular Dystrophy
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002301-61 Sponsor Protocol Number: 2215-CL-0603 Start Date*: 2020-01-14
    Sponsor Name:Astellas Pharma Global Development, Inc. (APGD)
    Full Title: A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Ty...
    Medical condition: FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002704-27 Sponsor Protocol Number: VBP15-004-A4 Start Date*: 2019-07-06
    Sponsor Name:ReveraGen BioPharma, Inc.
    Full Title: A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne...
    Medical condition: Duchenne muscular dystrophy (DMD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: BE (Completed) SE (Completed) NL (Completed) CZ (Completed) GR (Completed) ES (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2022-000691-19 Sponsor Protocol Number: BN43881 Start Date*: 2022-10-26
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A two-part, open-label systemic gene delivery study to evaluate the safety and expression of RO7494222 (SRP-9001) in subjects under the age of four with Duchenne muscular dystrophy
    Medical condition: Duchenne Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10052655 Duchenne muscular dystrophy gene carrier PT
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: ES (Ongoing) DE (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-003407-15 Sponsor Protocol Number: SRP-9001-104 Start Date*: 2023-08-08
    Sponsor Name:Sarepta Therapeutics, Inc
    Full Title: An Open-Label, Systemic Gene Delivery Study to Evaluate the Safety, Tolerability and Expression of SRP-9001 in association with imlifidase in Subjects with Duchenne Muscular Dystrophy with pre-exis...
    Medical condition: Duchenne muscular dystrophy
    Disease:
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: ES (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2019-003374-91 Sponsor Protocol Number: SRP-9001-301 Start Date*: 2022-09-12
    Sponsor Name:Sarepta Therapeutics, Inc.
    Full Title: A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBA...
    Medical condition: Duchenne Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10052655 Duchenne muscular dystrophy gene carrier PT
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: FR (Completed) BE (Completed) ES (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-005786-14 Sponsor Protocol Number: 7830 Start Date*: 2021-10-13
    Sponsor Name:Hôpitaux Universitaires de Strasbourg B.1.2
    Full Title: A randomized and controlled phase II national protocol in non NF1 pediatric and AYA (Adolescent and Young Adults) patients bearing a wild type BRAF gene newly diagnosed comparing a daily oral MEK i...
    Medical condition: Histologically proven grade 1 glioma/mixed glio-neuronal tumors or pleomorphic xanthoastrocytoma (PXA) confirmed
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002372-13 Sponsor Protocol Number: SRP-9001-303 Start Date*: 2023-01-19
    Sponsor Name:Sarepta Therapeutics, Inc.
    Full Title: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of SRP-9001 in Non-Ambulatory and Ambulatory Subjects...
    Medical condition: Duchenne Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10052655 Duchenne muscular dystrophy gene carrier PT
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: FR (Trial now transitioned) SE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-002989-12 Sponsor Protocol Number: IMR-BTL-201 Start Date*: 2020-06-02
    Sponsor Name:IMARA, Inc.
    Full Title: A Phase 2 Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects with Beta Thalassemia
    Medical condition: β-thalassemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10054660 Thalassemia beta LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DK (Prematurely Ended) NL (Prematurely Ended) FR (Prematurely Ended) GR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-023744-33 Sponsor Protocol Number: 2 Start Date*: 2012-11-12
    Sponsor Name:University of Rochester
    Full Title: Duchenne muscular dystrophy: double-blind randomized trial to find optimum steroid regimen
    Medical condition: Duchenne muscular dystrophy (DMD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2021-001081-38 Sponsor Protocol Number: ARCT-810-03 Start Date*: 2021-12-23
    Sponsor Name:Arcturus Therapeutics, Inc.
    Full Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Nested Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARCT-810 in Adolescent and Adult ...
    Medical condition: Ornithine transcarbamylase deficiency
    Disease: Version SOC Term Classification Code Term Level
    26.0 100000004850 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) FR (Completed) SE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-001813-35 Sponsor Protocol Number: 2020/65 Start Date*: 2022-04-21
    Sponsor Name:Centre Antoine Lacassagne
    Full Title: AGORA-1 /ALFA 2100 study : A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults with FLT3-ITD relapse/refractory (R/R) AML
    Medical condition: Adult patients (aged 18 years old or more) with a newly diagnosis of relapsed/refractory (R/R) AML associated to the presence a FLT3 gene internal tandem duplication (FLT3-ITD).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10001941 AML LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    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: View results
    EudraCT Number: 2022-003065-38 Sponsor Protocol Number: 1102-DMD-Pre-CT03 Start Date*: 2023-04-13
    Sponsor Name:Antisense Therapeutics Limited
    Full Title: A multicentre, randomised, double-blind, placebo-controlled and open label extension study to assess the efficacy, safety, and pharmacokinetic profile of two dose levels of ATL1102 administered by ...
    Medical condition: Duchenne Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: BG (Prematurely Ended)
    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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