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Clinical trials for C1-inhibitor

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   44336   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 ).  
     
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    19 result(s) found for: C1-inhibitor. Displaying page 1 of 1.
    EudraCT Number: 2008-000654-12 Sponsor Protocol Number: CE1145_1001 Start Date*: 2008-09-01
    Sponsor Name:Fachbereich Medizin der Johann Wolfgang Goethe-Universität Frankfurt/M.
    Full Title: PHARMACOKINETIC BERINERT P STUDY OF SUBCUTANEOUS VERSUS INTRAVENOUS ADMINISTRATION IN SUBJECTS WITH MODERATE HEREDITARY ANGIOEDEMA - THE PASSION STUDY
    Medical condition: Patients with hereditary angioedema (HAE) suffer from recurring and mostly unforeseeable attacks of acute oedema of subcutaneous tisses of various organs. The pathophysiological correlate of this d...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-003168-25 Sponsor Protocol Number: ONCE-AID1.0 Start Date*: 2023-02-28
    Sponsor Name:Academisch Medisch Centrum
    Full Title: Oral ONCE Daily prophylaxis with PHA-022121 in Patients with Acquired C1-Inhibitor Deficiency
    Medical condition: Acquired angioedema due to C1-inhibitor deficiency
    Disease: Version SOC Term Classification Code Term Level
    21.0 10040785 - Skin and subcutaneous tissue disorders 10081035 Acquired C1 inhibitor deficiency PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-005611-16 Sponsor Protocol Number: 52003 Start Date*: 2015-03-16
    Sponsor Name:Academic Medical Center, University of Amsterdam
    Full Title: Effect of Intravenous Administration of C1-inhibitor on Inflammation and Coagulation after Bronchial Instillation of House Dust Mite Allergen and Lipopolysaccharide in Allergic Asthma Patients
    Medical condition: Mild asthmatics with house dust mite allergy
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004855 10001705 Allergic asthma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-003710-13 Sponsor Protocol Number: NL41820.018.12 Start Date*: 2013-03-21
    Sponsor Name:Academic Medical Center
    Full Title: C1-inhibitor improves efficacy of red blood cell transfusion in patients suffering from autoimmune hemolytic anemia – an open-labeled pilot trial
    Medical condition: 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: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000720-36 Sponsor Protocol Number: POP-AID1.0 Start Date*: 2021-08-27
    Sponsor Name:Academisch Medisch Centrum
    Full Title: oral PHA-022121 for the acute treatment and prophylaxis Of angioedema attacks in Patients with Acquired C1-Inhibitor Deficiency
    Medical condition: Acquired angioedema due to C1-inhibitor deficiency
    Disease: Version SOC Term Classification Code Term Level
    21.0 10040785 - Skin and subcutaneous tissue disorders 10081035 Acquired C1 inhibitor deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-019670-32 Sponsor Protocol Number: B1 Start Date*: 2013-01-31
    Sponsor Name:AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
    Full Title: Pharmacokinetics and Safety of Human Pasteurised C1-Inhibitor Concentrate (Berinert/CE1145) in Subjects with Congenital C1-INH Deficiency and Frequent Hereditary Angioedema (HAE) Attacks.
    Medical condition: Hereditary Angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10056912 C1 esterase inhibitor deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004136-30 Sponsor Protocol Number: DEALSZ-2018-001 Start Date*: 2019-07-02
    Sponsor Name:Charité - Universitätsmedizin Berlin Klinik für Dermatologie und Allergologie
    Full Title: An Open-Label, Pilot Study to assess the effect of Lanadelumab on the clinical signs and symptoms of Hereditary angioedema with normal C1-inhibitor
    Medical condition: Lanadelumab in patients with Hereditary angioedema
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    20.0 10010331 - Congenital, familial and genetic disorders 10074782 Hereditary angioedema breakthrough attack LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005731-67 Sponsor Protocol Number: NLxxxxxxxxxx Start Date*: 2021-07-02
    Sponsor Name:Haaglanden Medisch Centrum
    Full Title: Complement Inhibition: Attacking the Overshooting Inflammation @fter Subarachnoid Hemorrhage - A phase II trial on the safety and efficacy of C1 esterase inhibitor for the acute management of subar...
    Medical condition: Subarachnoid hemorrhage
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004852 10042320 Subarachnoid hemorrhage LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003445-11 Sponsor Protocol Number: PHA022121-C201 Start Date*: 2020-12-18
    Sponsor Name:Pharvaris Netherlands BV
    Full Title: A Phase II, double-blind, placebo-controlled, Randomized, cross-over, dose-ranging study of oral PHA-022121 for Acute treatment of angioedema attacks in Patients with hereditary angioedema due to C...
    Medical condition: Hereditary angioedema attacks caused by Type 1 and 2 C1-Inhibitor Deficiency
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    21.0 10010331 - Congenital, familial and genetic disorders 10080956 Hereditary angioedema type I LLT
    21.0 10010331 - Congenital, familial and genetic disorders 10080957 Hereditary angioedema C1 inhibitor deficiency LLT
    21.0 10010331 - Congenital, familial and genetic disorders 10080960 Hereditary angioedema type II LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Completed) HU (Completed) NL (Completed) PL (Completed) DE (Completed) CZ (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-002339-24 Sponsor Protocol Number: NA Start Date*: 2012-05-25
    Sponsor Name:Barts and the London NHS Trust
    Full Title: Open label, single-centre study to evaluate the efficacy of the bradykinin (BK) B2 receptor antagonist, Icatibant, in the relief of symptoms resulting from moderate to severe angioedema unresponsiv...
    Medical condition: Idiopathic Angioedema
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-003921-99 Sponsor Protocol Number: CSL830_3003 Start Date*: 2020-04-27
    Sponsor Name:CSL Behring K.K.
    Full Title: An open-label, single-arm, non-randomized phase 3 study to evaluate clinical efficacy, safety, and pharmacokinetics of subcutaneous administration of human plasma-derived C1-esterase inhibitor in ...
    Medical condition: Hereditary angiodema (HAE) type I and II are genetic disorders that are associated with a deficiency in C1 esterase-inhibitor
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001044-22 Sponsor Protocol Number: ISIS721744-CS2 Start Date*: 2020-03-27
    Sponsor Name:Ionis Pharmaceuticals, Inc.
    Full Title: A Randomized, Double Blind, Placebo Controlled, Phase 2a Study to Assess the Clinical Efficacy of ISIS 721744, a Second Generation Ligand Conjugated Antisense Inhibitor of Prekallikrein, in Patient...
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2021-006906-58 Sponsor Protocol Number: PHA022121-C303 Start Date*: 2022-07-01
    Sponsor Name:Pharvaris Netherlands BV
    Full Title: A Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II)
    Medical condition: Hereditary angioedema attacks caused by Type 1 and 2 C1-Inhibitor Deficiency
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    21.0 10010331 - Congenital, familial and genetic disorders 10080956 Hereditary angioedema type I LLT
    21.0 10010331 - Congenital, familial and genetic disorders 10080957 Hereditary angioedema C1 inhibitor deficiency LLT
    24.0 10010331 - Congenital, familial and genetic disorders 10080960 Hereditary angioedema type II LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004823-20 Sponsor Protocol Number: TAK-743-3001 Start Date*: 2021-07-22
    Sponsor Name:Takeda Development Center Americas (TDCA)
    Full Title: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema with Normal C1-Inhibitor (C1-INH)
    Medical condition: non-histaminergic angioedema with normal C1-INH
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10002425 Angioedemas HLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) PL (Completed) NL (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-019037-10 Sponsor Protocol Number: INITIAtE Start Date*: 2010-11-24
    Sponsor Name:AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
    Full Title: IcatibaNt In Treatment of Idiopathic Angio Edema.
    Medical condition: Idiopathic angioedema.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10051379 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-010982-22 Sponsor Protocol Number: DSC/08/2357/38 Start Date*: 2009-04-20
    Sponsor Name:ITALFARMACO
    Full Title: Phase II study of the histone-deacetylase inhibitor GIVINOSTAT (ITF2357) in combination with hydroxyurea in patients with JAK2V617F positive Polycythemia Vera non-responder to hydroxyurea monotherapy
    Medical condition: Polycythemia Vera
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004851 10018847 Haematological disorders HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000227-13 Sponsor Protocol Number: PHA022121-C301 Start Date*: 2022-02-02
    Sponsor Name:Pharvaris Netherlands BV
    Full Title: A Phase II, Double-blind, Placebo-controlled, Randomized, Dose-ranging, Parallel Group Study to Evaluate the Safety and Efficacy of PHA-022121 Administered Orally for Prophylaxis Against Angioedema...
    Medical condition: Hereditary angioedema due to C1-Inhibitor Deficiency (Type I or Type II)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    26.0 10010331 - Congenital, familial and genetic disorders 10080960 Hereditary angioedema type II LLT
    21.0 10010331 - Congenital, familial and genetic disorders 10080957 Hereditary angioedema C1 inhibitor deficiency LLT
    21.0 10010331 - Congenital, familial and genetic disorders 10080956 Hereditary angioedema type I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned) AT (Trial now transitioned) IE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001703-20 Sponsor Protocol Number: SHP643-303 Start Date*: 2020-08-28
    Sponsor Name:Dyax Corporation, a Takeda company
    Full Title: A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema wi...
    Medical condition: non-histaminergic angioedema with normal C1-INH and acquired angioedema due to C1-INH deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10002425 Angioedemas HLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) HU (Completed) PL (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-001739-28 Sponsor Protocol Number: S63979 Start Date*: 2020-05-20
    Sponsor Name:UZLeuven
    Full Title: A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19.
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10038700 Respiratory infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    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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