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Clinical trials for octapharma

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   44041   clinical trials with a EudraCT protocol, of which   7319   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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    14 result(s) found for: octapharma. Displaying page 1 of 1.
    EudraCT Number: 2012-005770-57 Sponsor Protocol Number: version121219 Start Date*: 2013-03-25
    Sponsor Name:department of OBstetrics, Sahlgrenska university hospital
    Full Title: Clinical effect of Atenativ treatment on uterine blood flow and the amount of Atenativ needed to maintain a normal antithrombin level during two weeks in early and severe preeclampsia
    Medical condition: Early and severe preeclampsia with low antithrombin activity.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004307-40 Sponsor Protocol Number: ATN-106 Start Date*: 2022-01-31
    Sponsor Name:Octapharma AG
    Full Title: A multicentre, prospective, open-label, uncontrolled Phase 3 study to assess the efficacy, safety and pharmacokinetics of Atenativ in patients with congenital antithrombin deficiency undergoing sur...
    Medical condition: Congenital antithrombin deficiency
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004850 10083881 Antithrombin deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Ongoing) AT (Ongoing) FR (Ongoing) IT (Ongoing) DE (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004012-35 Sponsor Protocol Number: ALB-INFUS Start Date*: 2017-01-13
    Sponsor Name:Medical University of Graz
    Full Title: Effect of albumin infusion on oxidative albumin modification, albumin binding capacity and plasma thiol status
    Medical condition: refractory ascites, spontaneous bacterial peritonitis, hepatorenal syndrome
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000740-21 Sponsor Protocol Number: LEX-210 Start Date*: 2022-04-08
    Sponsor Name:Octapharma AG
    Full Title: Study of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on direct oral anticoagulant (DOAC) therapy with factor Xa inhibitor.
    Medical condition: Acute major bleeding in patients receiving DOAC therapy with factor Xa inhibitor
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10009731 Coagulation disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) IT (Ongoing) ES (Ongoing) AT (Ongoing) HR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003869-33 Sponsor Protocol Number: NL67754.078.18 Start Date*: 2019-05-07
    Sponsor Name:Erasmus University Medical Center
    Full Title: Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients.
    Medical condition: Hemophilia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004344-28 Sponsor Protocol Number: WIL-33 Start Date*: 2022-08-15
    Sponsor Name:Octapharma Pharmazeutika Produktionsges.m.b.H.
    Full Title: CLINICAL STUDY TO INVESTIGATE THE EFFICACY, PHARMACOKINETICS, IMMUNOGENICITY AND SAFETY OF WILATE IN SEVERE VON WILLEBRAND DISEASE PATIENTS UNDER THE AGE OF 6 YEARS
    Medical condition: Routine prophylaxis in children under the age of 6 years with severe VWD
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: CZ (Ongoing) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000444-22 Sponsor Protocol Number: NL75930.078.20 Start Date*: 2021-04-07
    Sponsor Name:Erasmus MC
    Full Title: Differences in coagulation between fresh frozen plasma and Solventdetergent plasma in pediatric congenital heart surgery
    Medical condition: coagulation in pediatric cardiac surgery
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000148-24 Sponsor Protocol Number: 1 Start Date*: 2018-06-14
    Sponsor Name:Norwegian University of Science and Technology
    Full Title: Safety and efficacy of plasma transfusion from exercise-trained donors in patients with early Alzheimer’s disease: the ExPlas Study
    Medical condition: Early Alzheimer's disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002668-29 Sponsor Protocol Number: 132796 Start Date*: 2020-06-25
    Sponsor Name:University College London
    Full Title: A Randomised Controlled Trial of plasma exchange with standard of care compared to standard of care alone in the treatment of severe COVID-19 infection (COVIPLEX)
    Medical condition: COVID-19
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2019-004769-41 Sponsor Protocol Number: 7572 Start Date*: 2020-02-18
    Sponsor Name:Hôpitaux Universitaires de Strasbourg
    Full Title: Prospective randomized versus placebo study evaluating the feasibility of plasma therapy in septic shock induced coagulopathy
    Medical condition: Septic shock
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004375-40 Sponsor Protocol Number: NGAM-12 Start Date*: 2020-07-09
    Sponsor Name:Octapharma Pharmazeutika Produktionsges.m.b.H.
    Full Title: Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia (“...
    Medical condition: Primary infection prophylaxis in patients with chronic lymphocytic leukemia (CLL) and secondary hypogammaglobulinemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10008976 Chronic lymphocytic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Trial now transitioned) DK (Trial now transitioned) IT (Ongoing) GR (Trial now transitioned) ES (Ongoing) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001631-46 Sponsor Protocol Number: NL65876.078.18 Start Date*: 2019-02-14
    Sponsor Name:Erasmus University Medical Center
    Full Title: Implementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease
    Medical condition: Von Willebrand disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004734-37 Sponsor Protocol Number: NORM-01 Start Date*: 2021-12-14
    Sponsor Name:Octapharma Pharmazeutika Prod.Ges.m.b.H
    Full Title: Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with p...
    Medical condition: Primary Immunodeficiency Diseases
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) SK (Trial now transitioned) PL (Trial now transitioned) HU (Trial now transitioned) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003427-38 Sponsor Protocol Number: MOTIVATE Start Date*: 2020-03-12
    Sponsor Name:HZRM – Hämophilie-Zentrum Rhein Main GmbH
    Full Title: MOdern Treatment of Inhibitor-PositiVe PATiEnts with Haemophilia A – An International Low-Interventional Pragmatic Investigator Initiated Trial
    Medical condition: Inhibitor-Positive patients with Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Trial now transitioned) NO (Trial now transitioned) SE (Trial now transitioned) FI (Trial now transitioned) HR (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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