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Clinical trials for Choroideremia

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   43895   clinical trials with a EudraCT protocol, of which   7301   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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    5 result(s) found for: Choroideremia. Displaying page 1 of 1.
    EudraCT Number: 2015-001383-18 Sponsor Protocol Number: Start Date*: 2015-11-30
    Sponsor Name:University of Oxford
    Full Title: An open label Phase 2 clinical trial of retinal gene therapy for choroideremia using an adeno-associated viral vector (AAV2) encoding Rab-escort protein 1 (REP1)
    Medical condition: Choroideremia - a currently incurable retinal degeneration caused by null mutations in the CHM gene encoding REP1 protein located on the X chromosome. The condition causes blindness in males by the...
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004853 10008791 Choroideremia LLT
    Population Age: Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2017-002395-75 Sponsor Protocol Number: NSR-REP-02 Start Date*: 2018-01-17
    Sponsor Name:NightstaRx Ltd (A Biogen Company)
    Full Title: An Open-Label Safety Study of Retinal Gene Therapy for Choroideremia with Bilateral, Sequential Administration of Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1)
    Medical condition: Choroideremia (CHM)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10008791 Choroideremia LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-003958-41 Sponsor Protocol Number: NSR-REP-01 Start Date*: 2016-10-31
    Sponsor Name:NightstaRx Ltd
    Full Title: A Randomised, Open Label, Outcomes-Assessor Masked, Prospective, Parallel Controlled Group, Phase 3 Clinical Trial Of Retinal Gene Therapy For Choroideremia Using An Adeno-Associated Viral Vector (...
    Medical condition: Choroideremia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10008791 Choroideremia LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed) FI (Completed) DK (Completed) NL (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: 2017-003104-42 Sponsor Protocol Number: NSR-CHM-OS2(273CH201) Start Date*: 2018-01-05
    Sponsor Name:NightstaRx Ltd (A Biogen Company)
    Full Title: A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects with Choroideremia Previously Treated with Adeno-Associated Viral Vector Encoding Rab Escort Prot...
    Medical condition: Choroideremia (CHM) X-Linked Retinitis Pigmentosa (XLRP)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10008791 Choroideremia LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10038914 Retinitis pigmentosa PT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Ongoing) GB (GB - no longer in EU/EEA) FI (Ongoing) FR (Ongoing) DK (Ongoing) NL (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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