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Clinical trials for Romiplostim

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
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   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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    25 result(s) found for: Romiplostim. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2008-004347-10 Sponsor Protocol Number: 20080009 Start Date*: 2009-06-17
    Sponsor Name:Amgen Inc
    Full Title: A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated with Im...
    Medical condition: Thrombocytopenia associated with ITP
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021245 Idiopathic thrombocytopenic purpura LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) CZ (Completed) DE (Completed) PL (Completed) BE (Completed) ES (Completed) HU (Completed) SE (Completed) EE (Completed) IT (Completed) LT (Completed) SI (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2009-016203-32 Sponsor Protocol Number: 20090340 Start Date*: 2009-11-19
    Sponsor Name:Amgen Inc
    Full Title: An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects with immune (Idiopathic) Thrombocytopenia Purpura (ITP).------------...
    Medical condition: Thrombocytopenia in pediatric subjects with ITP---------Sujetos Pediátricos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10043558 Thrombocytopenia purpura LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002992-25 Sponsor Protocol Number: 20140346 Start Date*: 2019-09-13
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving FOLFOX-based Chemotherapy for Treatment of...
    Medical condition: gastrointestinal or colorectal adenocarcinoma, which includes cancers of the esophagus, stomach, colon, or rectum.
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052360 Colorectal adenocarcinoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10053548 Gastrointestinal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) HU (Prematurely Ended) PT (Trial now transitioned) AT (Ongoing) PL (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-005019-96 Sponsor Protocol Number: 20101221 Start Date*: 2014-09-11
    Sponsor Name:Amgen Inc
    Full Title: A Single Arm, Open-label, Long-term Efficacy and Safety Study of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)
    Medical condition: Immune Thrombocytopenia (ITP) in Paediatric Subjects
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10043558 Thrombocytopenia purpura LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) ES (Completed) GB (Completed) HU (Completed) Outside EU/EEA PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-002564-69 Sponsor Protocol Number: 410/56 Start Date*: 2014-04-11
    Sponsor Name:GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
    Full Title: Double-blind, placebo-controlled multicenter phase II trial to evaluate the efficacy and safety of romiplostim for the treatment of chemotherapy-induced thrombocytopenia in subjects with relapse...
    Medical condition: Patients with relapsed ovarian cancer (2nd and 3rd line) treated with chemotherapy according to AGO guidelines who develop thrombocytopenia grade 3 and/or grade 4.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001006-28 Sponsor Protocol Number: 20170770 Start Date*: 2019-09-13
    Sponsor Name:Amgen Inc.
    Full Title: PROCLAIM: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of No...
    Medical condition: non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029519 Non-small cell lung cancer stage III PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057529 Ovarian cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070907 Ovarian cancer stage III PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070908 Ovarian cancer stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006201 Breast cancer stage III PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006202 Breast cancer stage IV PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) AT (Completed) HU (Completed) ES (Ongoing) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-001751-38 Sponsor Protocol Number: 2011_29 Start Date*: Information not available in EudraCT
    Sponsor Name:CHRU de Lille
    Full Title: SECONDARY PROPHYLAXIS USE OF ROMIPLOSTIM FOR THE PREVENTION OF THROMBOCYTOPENIA IN NEWLY DIAGNOSED GLIOBLASTOMA PATIENTS
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004851 10043559 Thrombocytopenia toxic LLT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018336 Glioblastoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-007258-75 Sponsor Protocol Number: 20060198 Start Date*: 2008-08-22
    Sponsor Name:Amgen Inc
    Full Title: A Randomized Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Thrombocytopenia in Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndr...
    Medical condition: Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS). ------------------------------------------------------------------------------ Síndrome Mielodisplásico (SMD) de Riesgo Bajo o Intermedio-1
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028533 Myelodysplastic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) SK (Prematurely Ended) NL (Completed) CZ (Prematurely Ended) IE (Completed) AT (Prematurely Ended) DE (Completed) HU (Completed) BE (Completed) GB (Completed) DK (Completed) SE (Prematurely Ended) FR (Completed) IT (Completed) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-001516-24 Sponsor Protocol Number: 20060197 Start Date*: 2007-08-23
    Sponsor Name:Amgen Inc
    Full Title: An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects with Myelodysplastic Syndromes (MDS)
    Medical condition: Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028533 Myelodysplastic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) FR (Completed) SE (Prohibited by CA) BE (Completed) DE (Completed) ES (Completed) HU (Completed) PL (Completed) CZ (Completed) AT (Completed) SK (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-018426-39 Sponsor Protocol Number: 20080279 Start Date*: 2014-09-09
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Determine the Safety and Efficacy of Romiplostim in Thrombocytopenic Pediatric Subjects with Immune Thrombocytopenia (ITP)
    Medical condition: Immune Thrombocytopenia (ITP) in Paediatric Subjects
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004851 10043558 Thrombocytopenia purpura LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-003824-12 Sponsor Protocol Number: ProRom Start Date*: 2011-10-21
    Sponsor Name:FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
    Full Title: Pilot phase II trial on safety and activity of secondary prophylaxis with Romiplostim in patients with non-Hodgkin lymphoma and chemotherapy-induced throm-bocytopenia
    Medical condition: chemotherapy-induced thrombocytopenia in patients affected by non-Hodgkin lymphoma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029547 Non-Hodgkin's lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-005429-10 Sponsor Protocol Number: EORTC-1926-BTG Start Date*: 2022-03-28
    Sponsor Name:European Organisation for Research and Treatment of Cancer EORTC
    Full Title: Romiplostim for thrombocytopenia induced by lomustine at first progression of MGMT promoter-methylated glioblastoma: a randomized phase II open label multicenter study
    Medical condition: thrombocytopenia caused by chemotherapy drug lomustine
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043554 Thrombocytopenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-000638-37 Sponsor Protocol Number: 20040209 Start Date*: 2008-02-28
    Sponsor Name:Amgen Inc.
    Full Title: An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
    Medical condition: Immune (Idiopathic) Thrombocytopenic Purpura
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021245 Idiopathic thrombocytopenic purpura LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) CZ (Completed) BE (Completed) AT (Completed) IE (Completed) GB (Completed) IT (Completed) ES (Prematurely Ended) SK (Completed)
    Trial results: View results
    EudraCT Number: 2010-019987-35 Sponsor Protocol Number: 20080435 Start Date*: 2010-07-23
    Sponsor Name:Amgen Inc
    Full Title: A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim.
    Medical condition: Adult immune thrombocytopenic purpura (ITP)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021245 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) DE (Completed) GB (Completed) ES (Completed) FR (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-004328-12 Sponsor Protocol Number: Europe Start Date*: 2015-01-23
    Sponsor Name:GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
    Full Title: Prospective validation of a predictive model of response to romiplostim in patients with IPSS low or intermediate-1 risk myelodysplastic syndrome (MDS) and thrombocytopenia - the EUROPE-trial
    Medical condition: Patients with IPSS low or intermediate-1 risk myelodysplastic syndrome (MDS) and thrombocytopenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Ongoing) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2021-006970-22 Sponsor Protocol Number: 2021-006970-22 Start Date*: 2022-08-18
    Sponsor Name:FISEVI
    Full Title: A multicentre, randomized, open-label study of romiplostim plus dexamethasone vs dexamethasone in patients with newly diagnosed primary immune thrombocytopenia
    Medical condition: Primary immune thrombocytopenia
    Disease: Version SOC Term Classification Code Term Level
    23.0 10005329 - Blood and lymphatic system disorders 10083842 Immune thrombocytopenia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-001257-22 Sponsor Protocol Number: 20210112 Start Date*: 2023-03-29
    Sponsor Name:Amgen, Inc.
    Full Title: Two Arm Bridging Study to Evaluate the Efficacy of Romiplostim in the Treatment of Non Asian Adult Severe Aplastic Anemia (SAA) Subjects who are Either Previously Untreated With Immunosuppressive T...
    Medical condition: Aplastic anemia (AA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10002967 Aplastic anaemia PT
    20.1 10005329 - Blood and lymphatic system disorders 10002968 Aplastic anaemia, unspecified LLT
    23.0 10005329 - Blood and lymphatic system disorders 10083893 Acquired aplastic anaemia LLT
    20.0 10005329 - Blood and lymphatic system disorders 10032510 Other specified aplastic anaemias LLT
    20.0 10005329 - Blood and lymphatic system disorders 10002969 Aplastic anemia LLT
    20.0 10005329 - Blood and lymphatic system disorders 10002037 Anaemia aplastic LLT
    20.0 10005329 - Blood and lymphatic system disorders 10002274 Anemia aplastic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-005453-76 Sponsor Protocol Number: C-935788-048 Start Date*: 2014-09-11
    Sponsor Name:Rigel Pharmaceuticals, Inc.
    Full Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
    Medical condition: Persistent/Chronic Immune Thrombocytopenic Purpura
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004851 10067644 Immune-mediated thrombocytopenic purpura LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) AT (Completed) ES (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2019-004103-12 Sponsor Protocol Number: TAK-079-1004 Start Date*: 2021-02-22
    Sponsor Name:Takeda Development Center Americas, Inc. (Takeda)
    Full Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia
    Medical condition: Primary immune thrombocytopenia
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004851 10050245 Autoimmune thrombocytopenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SI (Completed) BG (Completed) HR (Completed) IT (Completed) ES (Completed) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-010421-39 Sponsor Protocol Number: TRA112940 Start Date*: 2010-03-10
    Sponsor Name:GlaxoSmithKline
    Full Title: A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
    Medical condition: Chronic Idiopathic Thrombocytopenic Purpura
    Disease: Version SOC Term Classification Code Term Level
    15.1 10005329 - Blood and lymphatic system disorders 10021245 Idiopathic thrombocytopenic purpura PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) FR (Completed) HU (Completed) IT (Completed)
    Trial results: View results
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