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Clinical trials for filgrastim and pediatric

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   44353   clinical trials with a EudraCT protocol, of which   7380   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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    11 result(s) found for: filgrastim and pediatric. Displaying page 1 of 1.
    EudraCT Number: 2014-001772-55 Sponsor Protocol Number: XM02-ONC-201 Start Date*: 2015-01-26
    Sponsor Name:TEVA Pharmaceutical Industries Ltd
    Full Title: A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Efficacy, and Immunogenicity of Daily Subcutaneous Administration of 5 μg/kg tbo-filgrastim...
    Medical condition: Chemotherapy induced Neutropenia
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004851 10029355 Neutropenias HLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed) PL (Completed) RO (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2015-000087-34 Sponsor Protocol Number: XM22-08 Start Date*: 2015-06-05
    Sponsor Name:Merckle GmbH
    Full Title: An Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Lipegfilgrastim 100 μg/kg B...
    Medical condition: Neutropenia in pediatric patients diagnosed with Ewing family of Tumors or rhabdomyosarcoma receiving chemotherapy
    Disease: Version SOC Term Classification Code Term Level
    19.0 10005329 - Blood and lymphatic system disorders 10029354 Neutropenia PT
    19.0 10005329 - Blood and lymphatic system disorders 10016288 Febrile neutropenia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) SK (Completed) CZ (Completed) BG (Completed) DE (Ongoing) ES (Completed) RO (Completed) PL (Completed) BE (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2007-001430-14 Sponsor Protocol Number: peg-filgrastim Vs filgrastim nel t Start Date*: 2007-02-19
    Sponsor Name:AZIENDA OSPEDALIERA DI PADOVA
    Full Title: Peg-filgrastim Vs filgrastrim in pediatric patients.
    Medical condition: haematologic malignant tumors
    Disease: Version SOC Term Classification Code Term Level
    6.1 10000880 PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002697-45 Sponsor Protocol Number: ACT15378 Start Date*: 2019-03-04
    Sponsor Name:Sanofi-aventis recherche & developpement
    Full Title: Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Year...
    Medical condition: Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination with Chemotherapy in Pediatric Patients from 28 Days to Less than 18 Year...
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000846 Acute lymphocytic leukaemia PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) NO (Completed) FI (Completed) DK (Completed) FR (Completed) NL (Completed) PT (Completed) BE (Completed) DE (Completed) CZ (Completed) GR (Completed) Outside EU/EEA IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-005432-28 Sponsor Protocol Number: NEUGR-005 Start Date*: 2013-10-15
    Sponsor Name:Teva Pharmaceuticals Industries Ltd.
    Full Title: An open label, randomized, active controlled, dose finding study to evaluate the pharmacodynamics, pharmacokinetics, efficacy and safety of balugrastim at doses of 300 μg/kg and 670 μg/kg in pediat...
    Medical condition: Neutropenia induced by chemotherapy in patients with solid tumors
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10065252 Solid tumor LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) CZ (Completed) BG (Prematurely Ended) SK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-002172-39 Sponsor Protocol Number: VX21-CTX001-141 Start Date*: 2021-10-05
    Sponsor Name:VERTEX PHARMACEUTICALS INCORPORATED
    Full Title: A Phase 3 Study to Evaluate the Safety and Efficacy of a Single Dose of CTX001 in Pediatric Subjects With Transfusion-Dependent ß-Thalassemia
    Medical condition: Transfusion-Dependent ß Thalassemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10054660 Thalassemia beta LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003444-20 Sponsor Protocol Number: AAML1421 Start Date*: 2017-08-24
    Sponsor Name:Children's Oncology Group
    Full Title: A Phase 1/2 Study of CPX-351 Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children with Relapsed Acute Myeloid Leukemia (AML).
    Medical condition: Acute myeloid leukemia recurrent
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000012987 10060558 Acute myeloid leukemia recurrent LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2016-004554-14 Sponsor Protocol Number: PIX111 Start Date*: 2016-11-24
    Sponsor Name:CTI BioPharma Corp.
    Full Title: A Phase 1, Dose-Escalation Study of Pixantrone Monotherapy in Pediatric Patients with Relapsed or Refractory Cancer
    Medical condition: Relapsed or refractory solid tumors (excluding those with CNS tumors) or lymphoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10007050 Cancer LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2009-016075-30 Sponsor Protocol Number: GIMEMA LAL1308 Start Date*: 2010-07-09
    Sponsor Name:G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO
    Full Title: Therapy of the Young Adult Acute Lymphoblastic Leukemia (ALL): treatment intensification of the pediatric protocol AIEOP LLA-2000
    Medical condition: Acute Lymphoblastic Leukemia (ALL)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000844 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005923-42 Sponsor Protocol Number: TACL2008-002/ITCC033 Start Date*: 2013-04-09
    Sponsor Name:TACL
    Full Title: A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL, POETIC and ITCC
    Medical condition: relapsed T-ALL, T-NHL
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024338 Leukemia lymphoblastic acute LLT
    14.1 10005329 - Blood and lymphatic system disorders 10025321 Lymphomas non-Hodgkin's T-cell HLGT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) AT (Prematurely Ended) GB (Completed) IT (Prematurely Ended) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000415-87 Sponsor Protocol Number: 208467 Start Date*: 2019-12-11
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ES...
    Medical condition: Synovial sarcoma and Myxoid/Round Cell Liposarcoma (MRCLS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10042863 Synovial sarcoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073137 Myxoid liposarcoma PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) DE (Completed) IT (Trial now transitioned)
    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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