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Clinical trials for EPP

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    8 result(s) found for: EPP. Displaying page 1 of 1.
    EudraCT Number: 2009-011018-51 Sponsor Protocol Number: CUV029 Start Date*: 2009-08-06
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic ...
    Medical condition: Erythropoietic Protoporphyria (EPP)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015289 Erythropoietic protoporphyria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) FI (Completed) GB (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2007-000636-13 Sponsor Protocol Number: CUV017 Start Date*: 2008-06-17
    Sponsor Name:Clinuvel Pharmaceuticals Limited
    Full Title: A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP)
    Medical condition: Erythropoietic Protoporphyria (EPP)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015289 Erythropoietic protoporphyria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) IT (Completed) FR (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-002863-28 Sponsor Protocol Number: EPP001 Start Date*: 2007-09-26
    Sponsor Name:Guy's & St Thomas' NHS Foundation Trust
    Full Title: Investigation into the use of colestyramine as a therapy for patients with erythropoietic protoporphyria
    Medical condition: Erythropoietic protoporphyria (EPP)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015289 Erythropoietic protoporphyria LLT
    Population Age: Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004226-16 Sponsor Protocol Number: MT-7117-G01 Start Date*: Information not available in EudraCT
    Sponsor Name:Mitsubishi Tanabe Pharma Development America (MTDA), Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Adults and Adolescents with Erythropoietic Protoporphyria or ...
    Medical condition: Erythropoietic Protoporphyria or X-Linked Protoporphyria
    Disease: Version SOC Term Classification Code Term Level
    24.0 100000004850 10015289 Erythropoietic protoporphyria LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) SE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) FI (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001831-17 Sponsor Protocol Number: MT-7117-A-301 Start Date*: 2022-04-07
    Sponsor Name:Mitsubishi Tanabe Pharma Development America (MTDA), Inc.
    Full Title: A Phase 3, Multicenter, Open-label, Long-term, Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Pr...
    Medical condition: Erythropoietic Protoporphyria or X-Linked Protoporphyria
    Disease: Version SOC Term Classification Code Term Level
    24.0 100000004850 10015289 Erythropoietic protoporphyria LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) SE (Trial now transitioned) NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-004504-35 Sponsor Protocol Number: RF-2010-2311148 Start Date*: 2013-02-26
    Sponsor Name:IRCCS CENTRO SAN GIOVANNI DI DIO FATEBENEFRATELLI
    Full Title: The use of Oxytocin as adjunctive therapy for the treatment of schizophrenia: a randomized, double blind trial
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10039628 Schizophrenia and other psychotic disorders HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022095-31 Sponsor Protocol Number: IIB-ALO-2010-02 Start Date*: 2011-02-28
    Sponsor Name:Institut de Recerca HSCSP
    Full Title: Estudio doble ciego de tratatmiento preventivo con alopurinol 3% crema vs placebo de la eritrodisestesia palmoplantar secundaria al tratamiento con capecitabina
    Medical condition: eritrodisestesia palmoplantar secundaria al tratamiento con capecitabina
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-005032-29 Sponsor Protocol Number: EPP Start Date*: 2013-09-10
    Sponsor Name:Association Bigorre Douleurs
    Full Title: Transmucosal Effentora® efficacy and safety for pre-emptive procedural pain treatment in opioid tolerant cancer patients.
    Medical condition: Painful procedures requiring analgesia in patients receiving already opioids for their background pain.
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10058019 Cancer pain PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
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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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