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Clinical trials for Orphan virus

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   44346   clinical trials with a EudraCT protocol, of which   7374   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.
    How to search [pdf]
    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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    16 result(s) found for: Orphan virus. Displaying page 1 of 1.
    EudraCT Number: 2020-001167-93 Sponsor Protocol Number: Sobi.IMMUNO-101 Start Date*: 2020-03-27
    Sponsor Name:SWEDISH ORPHAN BIOVITRUM AB (PUBL)
    Full Title: A phase 2/3, randomized, open-label, parallel group, 3-arm, multicenter study investigating the efficacy and safety of intravenous administrations of emapalumab, an anti-interferon gamma (anti-IFN¿...
    Medical condition: SARS-CoV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002526-39 Sponsor Protocol Number: 20010133 Start Date*: 2015-07-02
    Sponsor Name:Swedish Orphan Biovitrum AB (publ)
    Full Title: A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Pediatric Subjects with Acute Leukemias Undergoing Myeloblative Therapy and Allogeneic Hematopoieti...
    Medical condition: Oral Mucositis
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-018146-38 Sponsor Protocol Number: MFN09/15 Start Date*: 2010-05-28
    Sponsor Name:Swedish Orphan International AB
    Full Title: Multicenter randomized controlled study comparing the efficacy and safety of natural Multi-subtype interferon alpha (Multiferon) in association with ribavirin versus retreatment with pegylated inte...
    Medical condition: Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    12.1 10019744 Hepatitis C LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005828-11 Sponsor Protocol Number: SAVE-MORE Start Date*: 2020-12-16
    Sponsor Name:Hellenic Institute for the Study of Sepsis
    Full Title: suPAR-GUIDED ANAKINRA TREATMENT FOR VALIDATION OF THE RISK AND EARLY MANAGEMENT OF SEVERE RESPIRATORY FAILURE BY COVID-19: THE SAVE-MORE DOUBLE-BLIND, RANDOMIZED, PHASE III CONFIRMATORY TRIAL
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10035738 Pneumonia viral NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001039-29 Sponsor Protocol Number: ESCAPE Start Date*: 2020-04-01
    Sponsor Name:HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS
    Full Title: EFFICIENCY IN MANAGEMENT OF ORGAN DYSFUNCTION ASSOCIATED WITH INFECTION BY THE NOVEL SARS-CoV-2 VIRUS (COVID-19) THROUGH A PERSONALIZED IMMUNOTHERAPY APPROACH: THE ESCAPE CLINICAL TRIAL
    Medical condition: Organ dysfunction by the novel SARS-Cov-2 virus
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10035738 Pneumonia viral NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001466-11 Sponsor Protocol Number: SAVE Start Date*: 2020-04-15
    Sponsor Name:Hellenic Institute for the Study of Sepsis
    Full Title: suPAR-GUIDED ANAKINRA TREATMENT FOR VALIDATION OF THE RISK AND EARLY MANAGEMENT OF SEVERE RESPIRATORY FAILURE BY COVID-19: THE SAVE OPEN-LABEL, NON-RANDOMIZED SINGLE-ARM TRIAL
    Medical condition: Lower respiratory tract infection by Covid-19 at high risk for development of severe respiratory failure
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10035738 Pneumonia viral NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001636-95 Sponsor Protocol Number: 282110 Start Date*: 2020-05-20
    Sponsor Name:University of Manchester
    Full Title: Subcutaneous and Intravenous anakinra in COVID-19 Infection - Feasibility & Pharmacokinetics/ Pharmacodynamics study
    Medical condition: Suspected or confirmed SARS-CoV-2 infection (confirmed by RNA-PCR)
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2010-022103-21 Sponsor Protocol Number: TUE-002 Start Date*: 2011-04-08
    Sponsor Name:University Hospital Tübingen
    Full Title: Neoadjuvant treatment of locoregional metastases in malignant melanoma (AJCC stage IIIB/C) with Multiferon: a phase IIa DeCOG trial
    Medical condition: The study is an open label, multicenter phase IIa clinical trial which is designed as a pilot project in order to establish the efficacy and tolerability of Multiferon as a neoadjuvant treatment o...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001963-10 Sponsor Protocol Number: 2020-CHITS-003 Start Date*: 2020-05-12
    Sponsor Name:Centre Hospitalier Intercommunal de Toulon La Seyne-sur-mer
    Full Title: Interleukin-1 (IL-1) and Interferon gamma (IFNg) inhibition during COVID 19 inflammation: Randomized, controlled study assessing efficacy and safety of Anakinra and Ruxolitinib
    Medical condition: Covid-19 disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003472-13 Sponsor Protocol Number: MYTH-1 Start Date*: 2019-10-31
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: Myocarditis Therapy with IL-1 inhibitor (MYTH-1): a double-blind, phase IIa, placebo-controlled, randomized clinical trial to evaluate the efficacy and safety of anakinra in addition to standard of...
    Medical condition: Endomyocardial biopsy proven virus-negative myocarditis with left ventricular ejection fraction lower than 55%.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10007541 - Cardiac disorders 10064539 Autoimmune myocarditis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001246-18 Sponsor Protocol Number: APHP200375 Start Date*: 2020-03-25
    Sponsor Name:Assistance Publique - Hôpitaux de Paris
    Full Title: Cohort Multiple randomized controlled trials open-label of immune modulatory drugs and other treatments in COVID-19 patients
    Medical condition: COVID-19
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-001734-36 Sponsor Protocol Number: DR200111 Start Date*: 2020-04-20
    Sponsor Name:CHRU de TOURS
    Full Title: Efficacy and safety of ANAkinra during Adult « COVID-19 » with Aggravating respiratory symptoms: a multicenter open-label controlled randomized trial
    Medical condition: COVID-19 infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-001819-12 Sponsor Protocol Number: CIS-COV Start Date*: 2022-10-13
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: Cysteamine in association with standard therapy for the treatment of hospitalized patients with COVID-19 pneumonia: phase 2 study on safety of a new antiviral and direct therapy on the host
    Medical condition: Covid-19 infection
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004862 10084401 COVID-19 respiratory infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2023-000102-25 Sponsor Protocol Number: PRECISION Start Date*: 2023-05-30
    Sponsor Name:Hellenic Institute for the Study of Sepsis
    Full Title: SAFETY AND EFFICACY OF ANAKINRA TREATMENT FOR PATIENTS WITH PERSISENT RESPIRATORY SYMPTOMS POST ACUTE COVID AND IMMUNE SYSTEM ACTIVATION: THE PRECISION DOUBLE-BLIND, RANDOMIZED CLINICAL TRIAL
    Medical condition: Post-acute COVID-19 syndrome (PACS)
    Disease: Version SOC Term Classification Code Term Level
    24.1 100000004862 10085504 Long COVID LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001500-41 Sponsor Protocol Number: COV-AID Start Date*: 2020-04-03
    Sponsor Name:University Hospital Ghent
    Full Title: A prospective, randomized, factorial design, interventional study to compare the safety and efficacy of combinations of blockade of interleukin-6 pathway and interleukin-1 pathway to best standard ...
    Medical condition: COVID-19 patients with acute hypoxic respiratory failure and systemic cytokine release syndrome.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-001748-24 Sponsor Protocol Number: ImmCoVA Start Date*: 2020-05-15
    Sponsor Name:Karolinska University Hospital
    Full Title: A multi-center, randomized, open-label study in patients with COVID-19 and respiratory distress not requiring mechanical ventilation, to compare standard-of-care with anakinra and tocilizumab treat...
    Medical condition: COVID-19 infection in patients with respiratory distress.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (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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