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Clinical trials for Hemolytic disease of the newborn

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    5 result(s) found for: Hemolytic disease of the newborn. Displaying page 1 of 1.
    EudraCT Number: 2017-000583-15 Sponsor Protocol Number: 60858 Start Date*: 2017-08-11
    Sponsor Name:Leiden University Medical Center
    Full Title: Randomized controlled trial on the use of EPO to reduce top-up transfusions in neonates with red blood cell alloimmunization treated with intrauterine transfusions
    Medical condition: Hemolytic disease of the newborn due to red blood cell alloimmunization
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10019513 Hemolytic disease of fetus or newborn, due to isoimmunization LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    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: 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: View results
    EudraCT Number: 2010-023955-27 Sponsor Protocol Number: 34760 Start Date*: 2011-04-29
    Sponsor Name:Leiden University Medical Center
    Full Title: Randomized controlled trial on the use of rhEPO to reduce top-up transfusions in neonates with red blood cell alloimmunization
    Medical condition: hemolytic disease of the newborn due to red blood cell alloimmunization
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-017434-45 Sponsor Protocol Number: 64,185-202 Start Date*: Information not available in EudraCT
    Sponsor Name:InfaCare Pharmaceutical Corporation
    Full Title: A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates with Hyperbilirubinemia
    Medical condition: Neonatal hyperbilirubinemia Hiperbilirubinemia neonatal
    Disease: Version SOC Term Classification Code Term Level
    14.0 10019805 - Hepatobiliary disorders 10020580 Hyperbilirubinaemia neonatal PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) ES (Prematurely Ended)
    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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