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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 ).  
     
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    1,407 result(s) found for: gene therapy. Displaying page 9 of 71.
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    EudraCT Number: 2014-005006-38 Sponsor Protocol Number: SOLTI-1303 Start Date*: 2015-03-30
    Sponsor Name:SOLTI
    Full Title: PATRICIA: A Phase II clinical trial of palbociclib and trastuzumab with or without letrozole in postmenopausal pretreated HER2-positive locally advanced or metastatic breast cancer patients
    Medical condition: Postmenopausal pretreated HER2-positive locally advanced or metastatic breast cáncer patients
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2016-004987-21 Sponsor Protocol Number: ONO-7579-01 Start Date*: 2017-09-13
    Sponsor Name:Ono Pharmaceutical Co., Ltd.
    Full Title: An open-label, multi-center, dose-escalation and expansion study to evaluate the safety and efficacy of ONO-7579 in patients with advanced solid tumors/ NTRK gene fusion positive advanced solid tumors
    Medical condition: Advanced solid tumors and Neurotrophic receptor tyrosine kinase (NTRK) gene fusion positive advanced solid tumors
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004864 10048683 Advanced cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001036-22 Sponsor Protocol Number: SOLTI-1114 Start Date*: 2013-10-15
    Sponsor Name:SOLTI
    Full Title: PAM50 HER2-enriched phenotype as a predictor of early response to neoadjuvant lapatinib plus trastuzumab in Stage I to IIIA HER2-positive breast cancer
    Medical condition: Untreated invasive breast carcinoma eligible for primary definitive surgery (Stage I-IIIA)
    Disease: Version SOC Term Classification Code Term Level
    14.1 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: ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-005004-21 Sponsor Protocol Number: THOR-TUE-01 Start Date*: 2015-12-23
    Sponsor Name:Universitätsklinikum Tübingen, STZ eyetrial am Department für Augenheilkunde
    Full Title: THOR - Tübingen Choroideremia gene therapy trial open label Phase 2 clinical trial using an adeno-associated viral vector (AAV2) encoding Rab-escort protein 1 (REP1)
    Medical condition: Choroideremia (CHM)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000015185 10008791 Choroideremia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-001906-61 Sponsor Protocol Number: 20180115 Start Date*: 2020-05-18
    Sponsor Name:Amgen Inc.
    Full Title: Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy
    Medical condition: Unresectable/Metastatic Stage IIIB-IVM1d Melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GR (Completed) PL (Prematurely Ended) ES (Ongoing) FR (Prematurely Ended) GB (GB - no longer in EU/EEA) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-001796-21 Sponsor Protocol Number: 2102-ONC-102 Start Date*: 2019-02-21
    Sponsor Name:Forma Therapeutics, Inc.
    Full Title: A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 Mutation
    Medical condition: Advanced Solid Tumors and Gliomas with an IDH1 Mutation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018338 Glioma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008734 Chondrosarcoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073073 Hepatobiliary cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065252 Solid tumor LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073077 Intrahepatic cholangiocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-005571-10 Sponsor Protocol Number: 03-08-21-12 Start Date*: Information not available in EudraCT
    Sponsor Name:Kennedy Krieger Inst. Johns Hopkins Medicine
    Full Title: DEXTROMETORPHAN IN RETT SYNDROME
    Medical condition: Rett syndrome (RTT) is a neurological disorder with devastating consequences on the brain. It is characterized by stagnation of development followed by regression, both occurring between age 6 mont...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: NO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-004486-86 Sponsor Protocol Number: SRA737-01 Start Date*: 2016-04-25
    Sponsor Name:Sierra Oncology, Inc.
    Full Title: A Phase 1/2 Trial of SRA737 (a Chk1 Inhibitor) Administered Orally in Subjects with Advanced Cancer
    Medical condition: Patients with histologically or cytologically proven advanced solid tumours, refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10007050 Cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-002806-28 Sponsor Protocol Number: SOLTI-1502 Start Date*: 2019-10-25
    Sponsor Name:SOLTI
    Full Title: TARGETING THE PAM50 HER2-ENRICHED PHENOTYPE WITH ENZALUTAMIDE IN HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE METASTATIC BREAST CANCER
    Medical condition: Male or pre/post-menopausal women age ≥ 18 years with advanced HR+/HER2-negative locally advanced/metastatic breast cancer resistant to endocrine therapy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-001375-11 Sponsor Protocol Number: not applicable Start Date*: 2007-05-16
    Sponsor Name:
    Full Title: Effects and health economic aspects of enzyme therapy in children and adults with Pompe disease Long-term follow-up of patients receiving commercially available Myozyme
    Medical condition: Pompe disease (glycogen storage disease type II) is a genetic, lysosomal storage disorder with a frequency of 1 in 40.000 newborns. The disease is caused by deficiency of alpha-glucosidase, a lysos...
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    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: 2008-006161-84 Sponsor Protocol Number: Version 2.1 Start Date*: 2009-06-17
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust
    Full Title: ARTiST - Aromasin Randomised Trial +/- Sutent as neoadjuvant Therapy for post-menopausal women with breast cancer.
    Medical condition: Breast cancer
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021944 Infiltrating ductal breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-003217-41 Sponsor Protocol Number: AGMT_ERCC1 Start Date*: 2012-05-23
    Sponsor Name:Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
    Full Title: Biomarker directed treatment in metastatic colorectal cancer
    Medical condition: This pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene expression status suggests better clinical results from historical experience in mCRC.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    20.0 100000016864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-001741-14 Sponsor Protocol Number: TEM-MM-101 Start Date*: 2018-12-13
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: A phase I/II dose escalation study evaluating safety and activity of autologous CD34+-enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human in...
    Medical condition: Multiple myeloma in early relapse after intensive front line therapy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-003248-63 Sponsor Protocol Number: QBGJ398-302 Start Date*: 2020-02-19
    Sponsor Name:QED Therapeutics, Inc.
    Full Title: Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alt...
    Medical condition: Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10046731 Urothelial carcinoma urethra recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Completed) FR (Completed) BE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) IT (Prematurely Ended) BG (Prematurely Ended) PT (Prematurely Ended) GR (Completed)
    Trial results: View results
    EudraCT Number: 2019-002936-97 Sponsor Protocol Number: LTFU-ABO-101 Start Date*: Information not available in EudraCT
    Sponsor Name:Abeona Therapeutics Europe SL.
    Full Title: A Long-term Follow-up Study of Patients with MPS IIIB from Gene Therapy Clinical Trials Involving the Administration of ABO-101 (rAAV9.CMV.hNAGLU)
    Medical condition: MPS IIIB is a devastating lysosomal storage disease, caused by a N-α-acetylglucosaminidase (NAGLU) gene defect. Infants with MPS IIIB appear normal at birth, but the disease is relentlessly progres...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Ongoing)
    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: 2017-002932-18 Sponsor Protocol Number: 42756493-BLC3001 Start Date*: 2018-02-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
    Medical condition: Advanced Urothelial Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10077840 Urothelial cancer of renal pelvis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Trial now transitioned) HU (Completed) ES (Ongoing) AT (Completed) FR (Trial now transitioned) DE (Ongoing) NL (Ongoing) PT (Completed) GR (Completed) PL (Completed) IT (Completed) DK (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000674-30 Sponsor Protocol Number: 2013-000674-30 Start Date*: 2013-07-24
    Sponsor Name:AOU SAN LUIGI GONZAGA - SCDU ONCOLOGIA MEDICA
    Full Title: Multicenter clinical trial, randomized phase II "window of opportunity" which aims to test the biological activity of abiraterone acetate administered as neoadjuvant therapy in patients with prosta...
    Medical condition: PROSTATE CANCER PATIENTS WITH HIGH RISK
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001569-20 Sponsor Protocol Number: 27709 Start Date*: 2015-07-06
    Sponsor Name:Merck Serono Co., Ltd.
    Full Title: A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen®
    Medical condition: Dwarfism, Pituitary
    Disease: Version SOC Term Classification Code Term Level
    18.0 10028395 - Musculoskeletal and connective tissue disorders 10013883 Dwarfism PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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