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Clinical trials for Cold Agglutinin

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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    • 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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    17 result(s) found for: Cold Agglutinin. Displaying page 1 of 1.
    EudraCT Number: 2009-016966-97 Sponsor Protocol Number: CAD01 Start Date*: 2010-06-08
    Sponsor Name:Universitätsklinikum Essen
    Full Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized, Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients with Cold Agglutinin Disease ...
    Medical condition: Cold agglutinin disease
    Disease: Version SOC Term Classification Code Term Level
    12.1 10009868 Cold type haemolytic anaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-006329-42 Sponsor Protocol Number: CAD0111 Start Date*: 2012-10-11
    Sponsor Name:G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
    Full Title: Short course of Bortezomib in anemic patients with refractory cold agglutinin disease
    Medical condition: Anaemia with refractory cold agglutinin disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10009868 Cold type haemolytic anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002039-40 Sponsor Protocol Number: CLNP023L12201 Start Date*: 2021-10-29
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, multi-center, phase 2 basket study to assess efficacy, safety and pharmacokinetics of iptacopan (LNP023) in participants with autoimmune benign hematological disorders
    Medical condition: Immune thrombocytopenia (ITP) Cold agglutinin disease (CAD)
    Disease: Version SOC Term Classification Code Term Level
    23.0 10005329 - Blood and lymphatic system disorders 10083842 Immune thrombocytopenia PT
    20.0 10005329 - Blood and lymphatic system disorders 10068863 Cold agglutinin disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004835-30 Sponsor Protocol Number: CAD5 Start Date*: 2012-10-23
    Sponsor Name:Department of Medicine, Haugesund Hospital
    Full Title: Therapy for chronic cold agglutinin disease: A prospective, non-randomized international multicenter trial on the safety and efficacy of bendamustine and rituximab combination therapy.
    Medical condition: Primary chronic cold agglutinin disease requiring treatment
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) DK (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2020-005854-90 Sponsor Protocol Number: ANX005-CAD-01 Start Date*: 2021-02-11
    Sponsor Name:Annexon, Inc.
    Full Title: A Phase 2, Single-Center, Open-Label, Repeat-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of Intravenous ANX005 in Participants with Primary...
    Medical condition: Primary Cold Agglutinin Disease (CAD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003539-12 Sponsor Protocol Number: EFC16216 Start Date*: 2017-11-15
    Sponsor Name:Bioverativ USA Inc.
    Full Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFU...
    Medical condition: Primary Cold Agglutinin Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10073785 Autoimmune haemolytic anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) NO (Completed) ES (Ongoing) BE (Ongoing) NL (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2021-003160-27 Sponsor Protocol Number: Sobi.PEGCET-101 Start Date*: 2022-05-31
    Sponsor Name:Swedish Orphan Biovitrum AB
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD)
    Medical condition: Patients with Cold Agglutinin Disease (CAD)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) NO (Prematurely Ended) HU (Prematurely Ended) AT (Prematurely Ended) IT (Prematurely Ended) BG (Prematurely Ended) ES (Prematurely Ended) FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-003363-35 Sponsor Protocol Number: APL2-CP-AIHA-208 Start Date*: 2018-07-05
    Sponsor Name:APELLIS PHARMACEUTCIALS, INC.
    Full Title: An open label, prospective, study to assess the safety, tolerability, efficacy and pharmacokinetics of APL-2 in patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Di...
    Medical condition: Patients affected by Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10002045 Anaemia haemolytic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003538-10 Sponsor Protocol Number: BIVV009-03 Start Date*: 2017-11-15
    Sponsor Name:Bioverativ USA Inc.
    Full Title: A PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION
    Medical condition: Primary Cold Agglutinin Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10073785 Autoimmune haemolytic anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) NO (Completed) ES (Completed) BE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-003652-22 Sponsor Protocol Number: INCB50465-206 Start Date*: 2018-05-18
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
    Medical condition: Autoimmune Hemolytic Anemia (AIHA), immunohemolytic anemia, autoimmune hemolytic anemia, immune complex hemolytic anemia. Warm AIHA, Cold AIHA
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10003825 Autoimmune hemolytic anemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) AT (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004998-53 Sponsor Protocol Number: OMB116024 Start Date*: 2013-02-05
    Sponsor Name:National and Kapodistrian University of Athens
    Full Title: A phase II study of the efficacy of the combination of ofatumumab with fludarabine and cyclophosphamide in patients with relapsed or refractory Waldenström’s Macroglobulinemia.
    Medical condition: Relapsed or refractory Waldenström’s Macroglobulinemia.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-001033-27 Sponsor Protocol Number: REMODEL-WM3 Start Date*: 2016-08-25
    Sponsor Name:FILO
    Full Title: REMODEL - WM3 An Open Label non-randomized Phase II Study exploring «chemo-free » treatment association with Idelalisib + Obinutuzumab in Patient with relapsed/refractory Waldenstrom’s Macroglobuli...
    Medical condition: Waldenstrom’s Macroglobulinemia (MW)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000506-37 Sponsor Protocol Number: ECWM-1 Start Date*: 2014-10-31
    Sponsor Name:University Hospital Ulm
    Full Title: Efficacy of first line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for patients with Waldenström's Macroglobulinemia
    Medical condition: Waldenström's Macroglobulinemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Ongoing) IT (Ongoing) PT (Prematurely Ended) SE (Ongoing) GR (Restarted) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-005053-20 Sponsor Protocol Number: ML39235 Start Date*: 2018-02-06
    Sponsor Name:Polish Myeloma Consortium
    Full Title: A multicenter, single-arm, phase II study to evaluate a safety and efficacy of obinutuzumab induction followed by 2 years of maintenance in patients with relapsed/refractory Waldenström Macroglobul...
    Medical condition: Waldenström's macroglobulinemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004851 10047802 Waldenstrom's macroglobulinaemias HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002324-36 Sponsor Protocol Number: MK1026-003 Start Date*: 2021-03-06
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    Full Title: A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10003899 B-cell lymphoma PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008976 Chronic lymphocytic leukemia LLT
    20.0 100000004851 10026798 Mantle cell lymphomas HLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10054693 Von Waldenstrom macroglobulinemia LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076596 Marginal zone lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IT (Ongoing) DK (Trial now transitioned) PL (Trial now transitioned) IE (Trial now transitioned) CZ (Trial now transitioned) HU (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004362-95 Sponsor Protocol Number: ECWM-2 Start Date*: 2019-04-12
    Sponsor Name:University Hospital Ulm
    Full Title: Efficacy of first line Bortezomib, Rituximab, Ibrutinib (B-RI) for patients with treatment naive Waldenström’s Macroglobulinemia
    Medical condition: Waldenström's Macroglobulinemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10047801 Waldenstrom's macroglobulinaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) GR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-003563-31 Sponsor Protocol Number: 26866138CAN 2021 Start Date*: 2007-03-09
    Sponsor Name:European Myeloma Network
    Full Title: Phase II Study of Combination Bortezomib (VELCADE, PS-341), Dexamethasone, and Rituximab (MabThera) (BDR) in Patients with previously untreated Waldenstrom’s Macroglobulinemia (WM).
    Medical condition: Newly diagnosed Waldenstrom's macroglobulinemia (WM)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10054695 Waldenstrom's macroglobulinemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Ongoing) NL (Ongoing) ES (Ongoing) FR (Ongoing) IT (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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