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Clinical trials for Amphotericin B

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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    41 result(s) found for: Amphotericin B. Displaying page 2 of 3.
    EudraCT Number: 2010-019562-91 Sponsor Protocol Number: GS-EU-131-0247 Start Date*: 2010-12-13
    Sponsor Name:Gilead Sciences International Ltd
    Full Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo Controlled Study to Assess the Efficacy, Safety and Tolerability of Prophylactic Liposomal Amphotericin B (AmBisome®) for the Prevention of...
    Medical condition: Invasive fungal infections (IFI) in subjects with Acute Lymphoblastic Leukemia (ALL) undergoing remission induction chemotherapy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10017533 Fungal infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) PT (Completed) ES (Completed) DE (Completed) GR (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-001549-32 Sponsor Protocol Number: Caspofungin vs Amfotericina Start Date*: 2006-03-01
    Sponsor Name:A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
    Full Title: Prospectic, multicentric, randomized, controlled trial for the evaluation of efficacy of Caspofungin vs Amfotericina B liposomiale for the empirical treatment of the FUO in children neutropenic for...
    Medical condition: Neutropenia (neutrophil count <500/mm3 for at least 10 days persistent fever for at least 72-96 hours, refrectory to the traetment with wide spectrum antibiotic appropriate for high risk pa...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029354 Neutropenia LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-000595-32 Sponsor Protocol Number: Ematonco/divmalinf/2006.1 Start Date*: 2006-09-06
    Sponsor Name:ISTITUTO GIANNINA GASLINI
    Full Title: Rescue therapy for indwelling central venous Hickmann-Broviac catheter related infections with antibiotic lock technique
    Medical condition: Patients with Hemato-oncologic disease or undergoing Hematopoietic stem cell transplantation
    Disease: Version SOC Term Classification Code Term Level
    6.1 10003997 PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003435-11 Sponsor Protocol Number: VL2397-201 Start Date*: 2018-08-14
    Sponsor Name:Vical Incorporated
    Full Title: A Phase 2 Study of VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis in Immunocompromised Adults
    Medical condition: Invasive Aspergillosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10051597 Cerebral aspergillosis PT
    20.1 10021881 - Infections and infestations 10006473 Bronchopulmonary aspergillosis PT
    20.0 10021881 - Infections and infestations 10003490 Aspergillosis pharyngeal LLT
    20.1 10021881 - Infections and infestations 10022881 Invasive bronchopulmonary aspergillosis LLT
    20.0 10021881 - Infections and infestations 10059259 Pulmonary aspergillosis LLT
    20.0 10021881 - Infections and infestations 10003488 Aspergillosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2007-000607-15 Sponsor Protocol Number: GS-IT-131-0177 Start Date*: 2007-12-06
    Sponsor Name:GILEAD SCIENCES S.R.L.
    Full Title: Phase II pilot multicenter study on efficacy and safety of liposomal amphotericin B (AmBisome) at 2 mg/kg/day in the treatment of candidemia and invasive candidiasis in nonneutropenic patients
    Medical condition: CANDIDEMIA AND INVASIVE CANDIDIASIS
    Disease: Version SOC Term Classification Code Term Level
    9.1 10007134 Candida infections HLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-008382-35 Sponsor Protocol Number: AIFA - FARM07YPBW Start Date*: 2010-04-08
    Sponsor Name:Azienda Ospedaliera di Perugia
    Full Title: Open , multicenter, randomized trial comparing two therapeutic approaches for the treatment of invasive fungal infections in neutropenic onco-hematologic patients.Empiric vs. ``presumptive`` (pree...
    Medical condition: opportunistic fungal infections in neutropenic onco-hematologic patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10017528 Fungal infectious disorders HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000240-26 Sponsor Protocol Number: PC_ASP_002 Start Date*: 2019-05-17
    Sponsor Name:Pulmocide Ltd
    Full Title: An open-label, pilot study to assess safety, tolerability, pharmacokinetics and effects of inhaled PC945 in the pre-emptive treatment of Aspergillus fumigatus colonisation in lung transplant recipi...
    Medical condition: Pre-emptive treatment of Aspergillus fumigatus colonisation in lung transplant recipients
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10059259 Pulmonary aspergillosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001433-74 Sponsor Protocol Number: LOCAL/2017/CR-01 Start Date*: 2017-06-29
    Sponsor Name:CHU de NIMES
    Full Title: Screening Anti-Fungal Exposure in Intensive Care Units – The French Cohort
    Medical condition: The study will recruit patients in intensive care unit prescribed to receive any of the chosen systemic antifungal agents
    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: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-001585-15 Sponsor Protocol Number: 2018-01671 Start Date*: 2020-01-30
    Sponsor Name:Centre Hospitalier Universitaire Vaudois
    Full Title: PTX3 genetically stratified randomized double-blinded allocation eventdriven clinical trial for antifungal prophylaxis in patients with acute myeloid leukemia
    Medical condition: Patients with acute myeloid leukemia (AML) or myelodysplastic syndrome in transformation (MDSit) who receive antifungal profylaxis during their treatment with an intensive chemotherapy regimen, inc...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-004495-21 Sponsor Protocol Number: GS-MC-131-0165 Start Date*: 2006-09-07
    Sponsor Name:Gilead Sciences GmbH
    Full Title: Pilot study on safety of four weekly administrations of 7 mg/kg of liposomal amphotericin B (AmBisome®) in antifungal primary prophylaxis treatment of elderly patients with acute lymphoblastic leuk...
    Medical condition: Antifungal prophylaxis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10049085 Antifungal prophylaxis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001290-17 Sponsor Protocol Number: F901318/0032 Start Date*: 2018-03-30
    Sponsor Name:F2G Biotech GmbH (FN 483749 x)
    Full Title: An open-label single-arm Phase IIb study of F901318 as treatment of invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi in pat...
    Medical condition: invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Ongoing) NL (Completed) DE (Completed) GB (GB - no longer in EU/EEA) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-001845-34 Sponsor Protocol Number: AMBIHOW Start Date*: 2011-09-15
    Sponsor Name:AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    Full Title: LIPOSOMAL AMPHOTERICIN B (AMBISOME) 10 mg/kg once a week for 10 weeks as maintenance antifungal therapy for Proven/Probable Invasive Fungal Infection in hematologic patients with Acute Myeloid Leuk...
    Medical condition: Proven/Probable Invasive Fungal Infection in hematologic patients with Acute Myeloid Leukaemia and/or in Allogeneic Hematopoietic Stem Cell Transplant recipients.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10061730 Bone marrow transplant PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    14.1 10005329 - Blood and lymphatic system disorders 10028484 Mycoses fungoides HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-003005-14 Sponsor Protocol Number: GVHD 1 Start Date*: 2010-12-30
    Sponsor Name:ASSOCIAZIONE MALATTIE SANGUE
    Full Title: Antimicotyc prophylaxis with Amphotericina B in lypidic complex aerosol in GVHD patients under steroid treatment
    Medical condition: GVHD patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018799 GVHD LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-000386-32 Sponsor Protocol Number: F901318/0041 Start Date*: 2022-01-21
    Sponsor Name:F2G Ltd.
    Full Title: A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with...
    Medical condition: invasive fungal infections due to Aspergillus spp.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10017533 Fungal infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-003745-40 Sponsor Protocol Number: GS-IT-131-0151 Start Date*: 2005-02-07
    Sponsor Name:GILEAD SCIENCES S.R.L.
    Full Title: Phase II pilot study on safety of administration of 3mg/kg/day three times a week until day 22 (21 days after transplantation day) and 7 mg/kg weekly from day 29 to the end of treatment ( day 50-8t...
    Medical condition: Fungal Infection High risk patients undergoing allogeneic stem-cell transplantation.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10017528 Fungal infectious disorders HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-007973-19 Sponsor Protocol Number: VORI-ZonMW Start Date*: 2009-04-09
    Sponsor Name:University Medical Center Groningen
    Full Title: Pharmacologic optimization of voriconazole - a prospective clustered group-randomized cross-over trial of therapeutic drug monitoring
    Medical condition: The objective of this prospective stratified cluster randomized cross-over trial is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) res...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003406-14 Sponsor Protocol Number: UHNM1219 Start Date*: 2017-09-26
    Sponsor Name:University Hospital of North Midlands NHS Trust
    Full Title: The Metoclopramoide and selective oral decontamination for Avoiding Pneumonia after Stroke (MAPS-2) Trial: a 2x2 double-blind, randomized controlled trial of metoclopramide and selective oral decon...
    Medical condition: Stroke We are testing two differnt intervetnions which could prevent pneumonia in stroke patietns. Prevention pneumonia could potentiallly speed up recovery and improve survival.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10035669 Pneumonia aspiration PT
    20.0 10029205 - Nervous system disorders 10061256 Ischaemic stroke PT
    20.1 10029205 - Nervous system disorders 10019016 Haemorrhagic stroke PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002503-26 Sponsor Protocol Number: X16082 Start Date*: 2017-03-14
    Sponsor Name:Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)
    Full Title: Phase Ib/II trial to evaluate safety and efficacy of oral ixazomib in combination with sirolimus and tacrolimus in the prophylaxis of chronic graft-versus-host disease
    Medical condition: Adult patiens after allogeneic stem cell transplantation
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004870 10018653 Graft-versus-host disease LLT
    19.1 100000004865 10067859 Allogenic stem cell transplantation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000804-17 Sponsor Protocol Number: GESITRA0110 Start Date*: 2011-08-10
    Sponsor Name:FUNDACION SEIMC-GESIDA
    Full Title: Randomized, multicentric, open label comparative trial to assess safety of Anidulafungina versus Anfotericina B Liposomal for antifungic profilaxis in high risk hepatic transplanted patients. AVALT...
    Medical condition: Hepatic transplanted patient with high risk of invasory fungic infection.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10049991 Candidal infection NOS LLT
    14.1 10021881 - Infections and infestations 10003486 Aspergillus infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-001833-87 Sponsor Protocol Number: 00600 Start Date*: 2008-06-20
    Sponsor Name:University Medical Center Freiburg
    Full Title: Use of Palifermin to reduce the duration, frequency and severity of oral mucositis after high dose therapy with BEAM and autologous peripheral blood stem cell transplantation in patients with malig...
    Medical condition: malign lymphoma (primary high risks patients: - therapy refractory / relapsed NHL - therapy refractory / relapsed M. Hodgkin - Burkitt-NHL
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006595 Burkitt's lymphoma LLT
    9.1 10029609 Non-Hodgkin's lymphoma unspecified histology aggressive recurrent LLT
    9.1 10029610 Non-Hodgkin's lymphoma unspecified histology aggressive refractory LLT
    9.1 10020328 Hodgkin's lymphoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
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