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Clinical trials for BCG

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   43845   clinical trials with a EudraCT protocol, of which   7282   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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    131 result(s) found for: BCG. Displaying page 1 of 7.
    1  2  3  4  5  6  7  Next»
    EudraCT Number: 2011-005653-31 Sponsor Protocol Number: P12.087 Start Date*: 2012-06-28
    Sponsor Name:LUMC, Department Infection Disease
    Full Title: Immune respons induced by vaccination with BCG
    Medical condition: BCG vaccination / immune respons
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001967-22 Sponsor Protocol Number: MK-3475-676 Start Date*: 2018-11-27
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-...
    Medical condition: High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10022877 Invasive bladder cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) BE (Ongoing) ES (Ongoing) FI (Trial now transitioned) GB (GB - no longer in EU/EEA) DE (Trial now transitioned) AT (Ongoing) PT (Trial now transitioned) IT (Ongoing) PL (Trial now transitioned) NL (Trial now transitioned) HU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001678-31 Sponsor Protocol Number: APHP200462 Start Date*: 2020-04-28
    Sponsor Name:Assistance Publique Hopitaux de Paris
    Full Title: Randomized controlled trial evaluating the efficacy of vaccination with Bacillus Calmette and Guérin (BCG) in the Prevention of COVID-19 via the strengthening of innate immunity in Health Care Work...
    Medical condition: COVID 19 Health care workers (medical or non-medical) in French hospitals in direct contact with COVID-19 patients, including nurses, medical doctors and other personnel working in wards in charge...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021979-85 Sponsor Protocol Number: 2009-323 Start Date*: 2017-06-01
    Sponsor Name:The Pediatric Clinics, The Juliane Marie Center, The Danish National Hospital "Rigshospitalet"
    Full Title: Danish: BCG vaccination og sygelighed blandt danske småbørn. En prospektivt, randomiseret, klinisk lægemiddelafprøvning. English: Bacille Calmette Guérin immunisation at birth and childhood morbidi...
    Medical condition: The study aims to test the hypothesis of the positive non-specific effect of BCG immunization at birth on early childhood morbidity in a high-income country.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10054112 Hospitalisation LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2004-003699-13 Sponsor Protocol Number: MAK-BLA-202 Start Date*: 2005-03-08
    Sponsor Name:INMUNO DESIGNED MOLECULES (IDM)
    Full Title: Phase II/III, Multicenter, Open-label, Randomized Study Comparing Autologous Intravesical Macrophage Cell Therapy (“Bexidem”) to Intravesical BCG-Therapy in Patients With Superficial Papillary Blad...
    Medical condition: BLADDER CANCER AFTER TRANSURETRHAL RESECTION
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002456-21 Sponsor Protocol Number: 74082 Start Date*: 2020-05-28
    Sponsor Name:Radboudumc
    Full Title: Enhancing the BCG-induced trained immunity response by addition of bisphosphonate or MMR vaccine: a possible preventive approach against COVID-19 (BCG-PLUS)
    Medical condition: Trained immunity COVID-19 This study will investigate whether oral bisphosphonate supplementation or the MMR vaccine can be used as immune potentiators when simultaneously administered with BCG, t...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-000966-23 Sponsor Protocol Number: BCG_influenza Start Date*: 2014-05-30
    Sponsor Name:Radboud University Nijmegen Medical Centre
    Full Title: The effects of BCG-vaccination on the immune response induced by influenza-vaccination in healthy volunteers A pilot proof-of-principle study
    Medical condition: Influenza virus infection
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004862 10022005 Influenza viral infections HLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-002567-96 Sponsor Protocol Number: CA209-7G8 Start Date*: 2021-01-07
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A phase 3, randomized, double-blind trial of nivolumab in combination with intravesical BCG versus standard of care BCG alone in participants with high-risk non-muscle invasive bladder cancer that ...
    Medical condition: Bladder Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Prematurely Ended) NL (Prematurely Ended) GR (Completed) SE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) AT (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-001186-85 Sponsor Protocol Number: HIVEC-HR Start Date*: 2016-06-09
    Sponsor Name:Dr. Felipe Villacampa
    Full Title: HIVEC HR: USE OF CHEMOHYPERTHERMIA WITH INTRAVESICAL MITOMYCIN (HIVEC) FOR THE TREATMENT OF PATIENTS WITH NMIBC AND HIGH RISK (HR)
    Medical condition: Non Muscle Invasive Bladder Cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-005520-42 Sponsor Protocol Number: BCG-LPS Start Date*: 2014-04-28
    Sponsor Name:Radboud University Nijmegen Medical Centre
    Full Title: The effects of BCG-vaccination on the innate immune response and immunoparalysis in healthy volunteers
    Medical condition: sepsis induced immunoparalysis
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10040047 Sepsis PT
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2017-003581-27 Sponsor Protocol Number: CA209-9UT Start Date*: 2020-07-03
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined with Intravesical BCG in Participants with BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Ca...
    Medical condition: BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005005 Bladder cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) ES (Prematurely Ended) GB (GB - no longer in EU/EEA) NL (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2019-003375-19 Sponsor Protocol Number: B8011006 Start Date*: 2020-07-20
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an anti-PD-1 antibody, in Combination with Bacillus Calmette-Guerin (BCG Induction With or Without BCG Mai...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10022877 Invasive bladder cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) GB (GB - no longer in EU/EEA) PT (Completed) BE (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-004677-18 Sponsor Protocol Number: BRD07/11-U Start Date*: 2008-10-03
    Sponsor Name:CHU de Nantes
    Full Title: Etude prospective monocentrique: Analyse et corrélation de la réaction immunologique locale et systémique induite par des instillations endovésicales de BCG (Bacille de Calmette et Guérin) dans le ...
    Medical condition: Patients présentant un cancer superficiel de la vessie.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002503-19 Sponsor Protocol Number: 62586 Start Date*: 2020-07-08
    Sponsor Name:UMC Utrecht
    Full Title: BCG vaccination to Reduce the impact of COVID-19 in healthcare workers (BRACE) Trial
    Medical condition: SARS-CoV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10047490 Virus identification and serology HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2017-002979-26 Sponsor Protocol Number: D419JC00001 Start Date*: 2018-07-16
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non Musc...
    Medical condition: Non-muscle invasive bladder cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005008 Bladder cancer stage I, with cancer in situ PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) ES (Restarted) FR (Trial now transitioned) PL (Trial now transitioned) AT (Ongoing) NL (Trial now transitioned) BE (Trial now transitioned) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000235-51 Sponsor Protocol Number: ANZUP1301 Start Date*: 2020-11-11
    Sponsor Name:Nottingham University Hospitals NHS Trust
    Full Title: BCG+MM Trial Adding mitomycin to BCG as adjuvant intravesical therapy for high-risk, non–muscle-invasive bladder cancer: a randomised phase 3 trial
    Medical condition: High grade non muscle invasive bladder cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2010-019181-91 Sponsor Protocol Number: EAURF2008-01 Start Date*: 2013-05-24
    Sponsor Name:EAU Foundation for Urological Research
    Full Title: Treatment of High Grade Non-Muscle Invasive Urothelial Carcinoma of the Bladder by Standard Number and Dose of Intravesical BCG Instillations Versus Reduced Number of Intravesical Instillations wi...
    Medical condition: Non muscle invasive bladder cancer after transurethral resection of the Bladder Tumor (TURT).
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Prematurely Ended) BE (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001783-28 Sponsor Protocol Number: BCG-COVID_HU_001 Start Date*: 2020-05-06
    Sponsor Name:National Korányi Institute of Pulmonology
    Full Title: REDUCING ABSENCE FROM WORK OF HEALTHCARE WORKERS DUE TO COVID-19 INFECTION BY BCG (BACILLUS CALMETTE-GUÉRIN) VACCINATION
    Medical condition: healthy volunteers working in the healthcare treating patients with new type of coronavirus (SARS-CoV-2) infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003904-15 Sponsor Protocol Number: 20202407 Start Date*: 2020-08-27
    Sponsor Name:University of Southern Denmark
    Full Title: Using BCG vaccine to enhance non-specific protection of senior citizens during the COVID-19 pandemic. A randomized clinical trial.
    Medical condition: Healthy volunteers, senior citizens of 65 years or older. Immune system activation after BCG vaccination. Acute infections, COVID-19 and self-reported respiratory illness will be monitored.
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10084382 Coronavirus disease 2019 LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2020-004506-64 Sponsor Protocol Number: 17000139BLC3002 Start Date*: 2023-01-09
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination with Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG...
    Medical condition: BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10046714 Urothelial carcinoma bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) PL (Ongoing) IT (Ongoing) PT (Trial now transitioned) NL (Trial now transitioned) ES (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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