Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Warm autoimmune hemolytic anemia

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   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    14 result(s) found for: Warm autoimmune hemolytic anemia. Displaying page 1 of 1.
    EudraCT Number: 2022-001773-31 Sponsor Protocol Number: CVAY736O12301 Start Date*: 2023-02-14
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of tr...
    Medical condition: warm autoimmune haemolytic anaemia (wAIHA)
    Disease: Version SOC Term Classification Code Term Level
    25.0 100000004851 10047822 Warm type haemolytic anaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001882-34 Sponsor Protocol Number: C-935788-058 Start Date*: 2020-01-28
    Sponsor Name:Rigel Pharmaceuticals, Inc.
    Full Title: A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
    Medical condition: Warm antibody autoimmune hemolytic anemia (wAIHA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10003825 Autoimmune hemolytic anemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed) GB (GB - no longer in EU/EEA) CZ (Completed) DE (Prematurely Ended) AT (Prematurely Ended) DK (Completed) FR (Completed) HU (Prematurely Ended) BE (Prematurely Ended) NL (Prematurely Ended) IT (Prematurely Ended) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2021-001671-16 Sponsor Protocol Number: ACT17209 Start Date*: 2021-10-08
    Sponsor Name:Sanofi aventis recherche et developpement
    Full Title: A multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia
    Medical condition: Warm autoimmune hemolytic anemia
    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: ES (Ongoing) DK (Trial now transitioned) IT (Trial now transitioned) HU (Completed) DE (Completed) AT (Completed)
    Trial results: (No results available)
    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 (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-003675-18 Sponsor Protocol Number: ANX005-wAIHA-02 Start Date*: 2021-01-11
    Sponsor Name:Annexon, Inc.
    Full Title: A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolyti...
    Medical condition: Warm Autoimmune Hemolytic Anemia
    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: DE (Completed) AT (Completed) FR (Completed) CZ (Completed) BG (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-001211-90 Sponsor Protocol Number: ALXN1830-WAI-202 Start Date*: 2021-08-11
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study of ALXN1830 Administered Subcutaneously in Patients with Warm Autoimmune Hemolytic Anemia (WAIHA)
    Medical condition: Warm Autoimmune Hemolytic Anemia (WAIHA)
    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: ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003880-24 Sponsor Protocol Number: ACT16832 Start Date*: 2021-03-24
    Sponsor Name:Sanofi-Aventis Recherche & Developpement
    Full Title: A multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia
    Medical condition: Warm autoimmune hemolytic anemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10047822 Warm type haemolytic anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) HU (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002844-66 Sponsor Protocol Number: INCB50465-309 Start Date*: 2022-05-30
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia (PATHWAY)
    Medical condition: Primary Warm Autoimmune Hemolytic Anemia
    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: DE (Completed) AT (Completed) IT (Completed) ES (Ongoing) NL (Completed) HU (Completed) FR (Completed)
    Trial results: View results
    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: 2019-003924-19 Sponsor Protocol Number: RVT-1401-2003 Start Date*: 2020-05-25
    Sponsor Name:Immunovant Sciences GmbH
    Full Title: A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia
    Medical condition: Warm Autoimmune Hemolytic Anemia
    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: ES (Prematurely Ended) GB (GB - no longer in EU/EEA) HU (Completed) PL (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004774-97 Sponsor Protocol Number: C-935788-057 Start Date*: 2019-10-23
    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 Warm Antibody Autoimmune Hemolytic Anemia
    Medical condition: Warm antibody autoimmune hemolytic anemia (wAIHA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10003825 Autoimmune hemolytic anemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BG (Completed) ES (Completed) CZ (Completed) HU (Completed) DK (Completed) DE (Completed) AT (Completed) BE (Completed) NL (Completed) IT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2008-006713-25 Sponsor Protocol Number: ASSENTE Start Date*: 2008-09-23
    Sponsor Name:OSPEDALE MAGGIORE DI MILANO (IRCCS)
    Full Title: A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA
    Medical condition: ANEMIE EMOLITICHE AUTOIMMUNI IDIOPATICHE
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-000720-17 Sponsor Protocol Number: MOM-M281-006 Start Date*: 2020-01-14
    Sponsor Name:Janssen-Cilag International NV
    Full Title: Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension
    Medical condition: Adults with Warm Autoimmune Hemolytic Anemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004851 10002285 Anemia hemolytic autoimmune (NOS) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) CZ (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) GR (Temporarily Halted) HU (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004055-37 Sponsor Protocol Number: ALXN1830-WAI-201 Start Date*: 2020-05-06
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients with Warm Autoimmune Hemolytic Anemia
    Medical condition: WAIHA
    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: ES (Prematurely Ended)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun May 04 07:13:13 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA