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Clinical trials for Palifermin

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   44335   clinical trials with a EudraCT protocol, of which   7366   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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    16 result(s) found for: Palifermin. Displaying page 1 of 1.
    EudraCT Number: 2010-021186-70 Sponsor Protocol Number: 10089DMCA-CS Start Date*: 2010-10-01
    Sponsor Name:Belfast Health and Social Care Trust
    Full Title: Keratinocyte growth factor in Acute lung injury to REduce pulmonary dysfunction – a randomised placebo controlled trial (KARE)
    Medical condition: Acute Lung Injury
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    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: 2006-003709-15 Sponsor Protocol Number: 20050219 Start Date*: 2006-11-08
    Sponsor Name:Swedish Orphan Biovitrum AB (publ)
    Full Title: A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin (Pre- and Post Chemotherapy and Pre-Chemotherapy only) for Reduction in Severity of Oral Mucositis in S...
    Medical condition: Oral Mucositis Induced by High Dose Chemotherapy Cataract development associated with palifermin administration
    Disease: Version SOC Term Classification Code Term Level
    13.1 10017947 - Gastrointestinal disorders 10028130 Mucositis oral LLT
    13.1 10015919 - Eye disorders 10007739 Cataract PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) CZ (Completed) IE (Completed) AT (Completed) BE (Completed) FI (Completed) SE (Completed) DE (Completed) DK (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2005-000213-35 Sponsor Protocol Number: 20020402 Start Date*: 2005-08-05
    Sponsor Name:Swedish Orphan Biovitrum AB (publ.)
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduct...
    Medical condition: Oral mucositis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004856 10028130 Mucositis oral LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) AT (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-005007-14 Sponsor Protocol Number: 20040122 Start Date*: 2005-05-20
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) for Reduction of Oral Mucositis in Subjects Wit...
    Medical condition: Oral Mucositis
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004856 10028130 Mucositis oral LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2004-002016-28 Sponsor Protocol Number: 20040118 Start Date*: 2005-01-04
    Sponsor Name:Amgen
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduct...
    Medical condition: Oral mucositis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004856 10028130 Mucositis oral LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) AT (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-001716-31 Sponsor Protocol Number: 20040124 Start Date*: 2015-09-17
    Sponsor Name:Swedish Orphan Biovitrum AB (publ.)
    Full Title: A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduct...
    Medical condition: Oral Mucositis
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004856 10028130 Mucositis oral LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-003116-33 Sponsor Protocol Number: 20030185 Start Date*: 2005-04-11
    Sponsor Name:Swedish Orphan Biovitrum (Sobi) AB (publ)
    Full Title: A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy fo...
    Medical condition: Dysphasia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10013950 Dysphagia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-013791-49 Sponsor Protocol Number: RHM MED 0879 Start Date*: 2009-09-23
    Sponsor Name:Southampton Universities Hospital Trust
    Full Title: Safety and Efficacy of parenteral KGF in moderate asthma subjects
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    12 10003553 Asthma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2006-001923-20 Sponsor Protocol Number: PALIFERMIN EXPANDED ACCESS PROTOCO Start Date*: 2006-04-27
    Sponsor Name:OSPEDALE S. RAFFAELE
    Full Title: Palifermin use in patients , out of clinical investigation, which are receiving chemioterapic therapy with staminal cells to reduce severuty and incidence of mucositis.
    Medical condition: mucositis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028128 Mucositis management LLT
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-004642-14 Sponsor Protocol Number: 20050100 Start Date*: 2006-01-30
    Sponsor Name:Amgen S.A.
    Full Title: Estudio abierto, de un solo grupo, de palifermin para la reducción de la mucositis en sujetos con linfoma no Hodgkin (LNH) o mieloma múltiple (MM) sometidos a quimioterapia a altas dosis y trasplan...
    Medical condition: Mucositis Oral Oral Mucositis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-003683-54 Sponsor Protocol Number: OSHO #76 Start Date*: 2008-06-18
    Sponsor Name:GMIHO Gesellschaft für medizinische Innovation/Hämatologie und Onkologie mbH
    Full Title: Prospektive, offene, randomisierte, multizentrische Studie zur Effektivität von Palifermin in der Prophylaxe der Mukositis nach allogener Stammzelltransplantation mit myeloablativer Granzkörperbest...
    Medical condition: Patients suffering from leukemia (acute or chronic), receiving allogenic blood stem cell transplantation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-000441-58 Sponsor Protocol Number: 08005DM-A Start Date*: 2009-01-22
    Sponsor Name:Belfast City Hospital
    Full Title: Investigation of the protective effects of keratinocyte growth factor (KGF) in a human lipopolysaccharide induced model of acute lung injury
    Medical condition: Acute lung injury
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-012717-22 Sponsor Protocol Number: UCL/08/0167 Start Date*: 2010-01-13
    Sponsor Name:University College London
    Full Title: UKALL14 - A randomized trial for adults with newly diagnosed acute lymphoblastic leukemia
    Medical condition: Acute Lymphoblastic Leukemia (ALL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    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
    EudraCT Number: 2011-005606-30 Sponsor Protocol Number: CAM-THY Start Date*: 2012-04-25
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
    Full Title: Keratinocyte Growth Factor - promoting thymic reconstitution and preventing autoimmunity after alemtuzumab (Campath-1H) treatment of multiple sclerosis. CAM-THY
    Medical condition: This trial will test the efficacy of Kepivance in the prevention of new autoimmune diseases in patients who have multiple sclerosis (MS)who are being treated with alemtuzumab.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038359 - Renal and urinary disorders 10058948 Nephritis autoimmune PT
    14.1 10014698 - Endocrine disorders 10049046 Autoimmune thyroiditis PT
    14.1 10021428 - Immune system disorders 10061664 Autoimmune disorder PT
    14.1 10014698 - Endocrine disorders 10068004 Autoimmune hyperthyroidism LLT
    14.1 10005329 - Blood and lymphatic system disorders 10050245 Autoimmune thrombocytopenia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (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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