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Clinical trials for Mycobacterial infectious disorders

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   44412   clinical trials with a EudraCT protocol, of which   7421   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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    4 result(s) found for: Mycobacterial infectious disorders. Displaying page 1 of 1.
    EudraCT Number: 2020-002545-42 Sponsor Protocol Number: INS-415 Start Date*: 2021-02-08
    Sponsor Name:Insmed Incorporated
    Full Title: ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous M...
    Medical condition: Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061229 Lung infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) DE (Completed) HU (Completed) AT (Completed) NL (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-003079-16 Sponsor Protocol Number: INS-416 Start Date*: 2021-02-08
    Sponsor Name:Insmed Incorporated
    Full Title: ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen ...
    Medical condition: Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
    Disease: Version SOC Term Classification Code Term Level
    22.1 10021881 - Infections and infestations 10061229 Lung infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) FR (Trial now transitioned) DE (Ongoing) AT (Trial now transitioned) HU (Completed) GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-006765-82 Sponsor Protocol Number: MOXEP Start Date*: 2009-05-29
    Sponsor Name:ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
    Full Title: Preventive therapy for multidrug-resistant tuberculosis: a multicentre clincal trial.
    Medical condition: Close contacts of an infectious respiratory of a MDR-TB who are diagnosed with tuberculosis infection that is likely to have been acquired from the MDR-TB case will be eligible for inclusion in th...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028440 HLGT
    9.1 10044756 HLT
    9.1 10021868 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-000252-28 Sponsor Protocol Number: SHCVOLT1 Start Date*: 2009-03-13
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust
    Full Title: A Multi-Centre Prospective Controlled Trial Comparing Calcineurin Inhibitor Monotherapy With Sirolimus Monotherapy in Hepatitis C Infected Patients with Hepatic Fibrosis Following Liver Transplanta...
    Medical condition: Patients who have undergone liver transplantation and are infected with Hepatitis C virus.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052779 Transplant rejections HLT
    9.1 10024970 Respiratory tract infections HLGT
    9.1 10046577 Urinary tract infections HLT
    9.1 10001032 Acute pyelonephritis LLT
    9.1 10040072 Septicaemia LLT
    9.1 10019972 Herpes viral infections HLT
    9.1 10028440 Mycobacterial infectious disorders HLGT
    9.1 10015107 Epstein-Barr viral infections HLT
    9.1 10011831 Cytomegalovirus infection LLT
    9.1 10019974 Herpes zoster LLT
    9.1 10058872 Fungal sepsis LLT
    9.1 10040808 Skin cancer PT
    9.1 10051358 Post transplant lymphoproliferative disorder LLT
    9.1 10043555 Thrombocytopenias HLT
    9.1 10037561 Purpura thrombocytopenic LLT
    9.1 10002034 Anaemia PT
    9.1 10018932 Haemolytic uraemic syndrome PT
    9.1 10024384 Leukopenia PT
    9.1 10029355 Neutropenias HLT
    9.1 10033661 Pancytopenia PT
    9.1 10013505 Disturbance of liver function tests LLT
    9.1 10002218 Anaphylaxis LLT
    9.1 10002425 Angioedemas HLT
    9.1 10015665 Exfoliative dermatitis LLT
    9.1 10020764 Hypersensitivity vasculitis LLT
    9.1 10021015 Hypokalaemia PT
    9.1 10021058 Hypophosphataemia PT
    9.1 10020603 Hypercholesterolaemia PT
    9.1 10020635 Hyperglycaemia PT
    9.1 10020869 Hypertriglyceridaemia PT
    9.1 10043071 Tachycardia PT
    9.1 10034474 Pericardial effusion PT
    9.1 10048642 Lymphocele PT
    9.1 10051055 Deep vein thrombosis PT
    9.1 10037377 Pulmonary embolism PT
    9.1 10025282 Lymphoedema PT
    9.1 10035742 Pneumonitis PT
    9.1 10035598 Pleural effusion PT
    9.1 10015090 Epistaxis PT
    9.1 10037394 Pulmonary haemorrhage PT
    9.1 10000081 Abdominal pain PT
    9.1 10012735 Diarrhoea PT
    9.1 10042128 Stomatitis PT
    9.1 10033645 Pancreatitis PT
    9.1 10000496 Acne PT
    9.1 10037844 Rash PT
    9.1 10003239 Arthralgia PT
    9.1 10031264 Osteonecrosis PT
    9.1 10037032 Proteinuria PT
    9.1 10029164 Nephrotic syndrome PT
    9.1 10030124 Oedema peripheral PT
    9.1 10021519 Impaired healing PT
    9.1 10030095 Oedema PT
    9.1 10037660 Pyrexia PT
    9.1 10005630 Blood lactate dehydrogenase increased PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    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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