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Clinical trials for RHD

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   44338   clinical trials with a EudraCT protocol, of which   7368   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.
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    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.
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    4 result(s) found for: RHD. Displaying page 1 of 1.
    EudraCT Number: 2009-011017-24 Sponsor Protocol Number: ADNC-0726 Start Date*: 2009-08-03
    Sponsor Name:LFB Biotechnologies
    Full Title: A Phase II, open-label, randomised, dose-finding study to compare the efficacy (in terms of clearance of RhD-positive RBCs) and safety of LFB-R593, a monoclonal anti-RhD antibody, vs Rhophylac®, a ...
    Medical condition: Prophyllaxis against RhD isoimmunisation during pregnancy (anti-D prophylaxis) Treatment of RhD negative individuals after incompatible transfusions with blood components containing RhD-positive r...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019513 Hemolytic disease of fetus or newborn, due to isoimmunization LLT
    9.1 10044360 Transfusion with incompatible blood LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-006081-15 Sponsor Protocol Number: Sym001-03 Start Date*: 2008-05-20
    Sponsor Name:Symphogen A/S
    Full Title: A multi-centre, single intravenous dose, exploratory dose-finding, open label trial on the safety and efficacy of Sym001 in the treatment of Immune Thrombocytopenic Purpura (ITP) in RhD positive, n...
    Medical condition: Immune Thrombocytopenic Purpura (ITP) in RhD positive, non-splenectomized adult subjects
    Disease: Version SOC Term Classification Code Term Level
    9.1 10043561 Thrombocytopenic purpura LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) BE (Completed) GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003570-49 Sponsor Protocol Number: KB065 Start Date*: 2021-02-05
    Sponsor Name:Kedrion S.p.A.
    Full Title: Phase III, Open-label, Uncontrolled, Multicenter Study to Assess Efficacy, Pharmacokinetics and Safety of IMMUNORHO in the Prevention of RhD Isoimmunization in Rh(D) negative Women Pregnant with Rh...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10039038 Rhesus isoimmunization LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Completed) CZ (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-004958-42 Sponsor Protocol Number: MOM-M281-003 Start Date*: 2019-01-11
    Sponsor Name:Momenta Pharmaceuticals, Inc.
    Full Title: A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease ...
    Medical condition: Early onset Severe Hemolytic Disease of the fetus and newborn (HDFN)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10019512 Hemolytic disease due to Rh isoimmunization of fetus or newborn LLT
    Population Age: In utero, Under 18, Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) NL (Completed) SE (Completed) ES (Ongoing)
    Trial results: (No results available)
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    Query did not match any studies.
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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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