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Clinical trials for C1-inhibitor deficiency

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
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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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    9 result(s) found for: C1-inhibitor deficiency. 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: 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: 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: 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: 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: 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: 2019-003921-99 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: 2019-001703-20 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
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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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