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Clinical trials for hereditary angioedema

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    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   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).

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    15 result(s) found for: hereditary angioedema. Displaying page 1 of 1.
    EudraCT Number: 2021-003603-18 Sponsor Protocol Number: 331-201 Start Date*: 2022-10-06
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 1/2, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of BMN 331, an Adeno-Associated Virus (AAV) Vector-Mediated Gene Transfer of Human SERPING1, in Su...
    Medical condition: Hereditary Angioedema (HAE)
    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 10080957 Hereditary angioedema C1 inhibitor deficiency LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-000197-14 Sponsor Protocol Number: ISIS721744-CS3 Start Date*: 2020-06-16
    Sponsor Name:Ionis Pharmaceuticals, Inc.
    Full Title: An Open-Label Extension Study of ISIS 721744 in Patients with Hereditary Angioedema
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    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: 2020-003918-12 Sponsor Protocol Number: CSL312_3002 Start Date*: 2021-06-08
    Sponsor Name:CSL Behring LLC
    Full Title: An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
    Medical condition: Hereditary angioedema
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) CZ (Ongoing) HU (Ongoing) NL (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004230-37 Sponsor Protocol Number: BCX7353-312 Start Date*: Information not available in EudraCT
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: An open-label study to provide berotralstat access to subjects with type 1 and 2 hereditary angioedema who were previously enrolled in berotralstat studies
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing) CZ (Ongoing) SK (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    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) HU (Ongoing) IT (Ongoing) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000757-93 Sponsor Protocol Number: ISIS721744-CS7 Start Date*: Information not available in EudraCT
    Sponsor Name:IONIS PHARMACEUTICALS, INC.
    Full Title: An Open-Label, Long Term Safety and Efficacy Study of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)
    Medical condition: Hereditary Angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) ES (Ongoing) BE (Ongoing) IT (Ongoing) DE (Ongoing) NL (Ongoing) DK (Completed) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-005932-50 Sponsor Protocol Number: BCX7353-304 Start Date*: 2022-10-05
    Sponsor Name:BioCryst Pharmaceuticals, Inc.
    Full Title: A PHASE 3 STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF BEROTRALSTAT PROPHYLAXIS IN CHILDREN WITH HEREDITARY ANGIOEDEMA WHO ARE 2 TO < 12 YEARS OF AGE
    Medical condition: Hereditary Angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing) AT (Ongoing) IT (Ongoing) ES (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001693-33 Sponsor Protocol Number: ITL-2002-CL-001 Start Date*: 2022-03-30
    Sponsor Name:Intellia Therapeutics, Inc.
    Full Title: Phase 1/2 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NTLA-2002 in Adults with Hereditary Angioedema (HAE)
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) FR (Ongoing) DE (Ongoing) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-002571-19 Sponsor Protocol Number: ISIS721744-CS5 Start Date*: Information not available in EudraCT
    Sponsor Name:Ionis Pharmaceuticals, Inc.
    Full Title: A Phase 3 Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ISIS 721744 in Patients with Hereditary Angioedema (HAE)
    Medical condition: Hereditary Angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) IT (Ongoing) ES (Ongoing) NL (Completed) DE (Completed) BE (Completed) BG (Completed) DK (Prematurely Ended) PL (Completed)
    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 (Ongoing) AT (Ongoing) IE (Trial now transitioned)
    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 (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001176-42 Sponsor Protocol Number: KVD900-302 Start Date*: 2022-09-30
    Sponsor Name:KalVista Pharmaceuticals Ltd
    Full Title: An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with He...
    Medical condition: Hereditary Angioedema Type I or II
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004850 10080956 Hereditary angioedema type I LLT
    26.0 100000004850 10080960 Hereditary angioedema type II LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing) BG (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) IT (Ongoing) DE (Ongoing) PT (Trial now transitioned) SK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-004282-15 Sponsor Protocol Number: C1 1304-01 Start Date*: 2005-06-22
    Sponsor Name:PHARMING TECHNOLOGIES B.V.
    Full Title: A randomized, placebo-controlled, double-blind Phase III study of the efficacy and safety of recombinant human C1 inhibitor for the treatment of acute attacks in patients with hereditary angioedema
    Medical condition: hereditary angioedema (HAE) treatment
    Disease: Version SOC Term Classification Code Term Level
    6.1 10051298 PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001226-21 Sponsor Protocol Number: KVD900-301 Start Date*: 2022-12-01
    Sponsor Name:KalVista Pharmaceuticals Ltd
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Dema...
    Medical condition: Hereditary Angioedema Type I or II
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004850 10080956 Hereditary angioedema type I LLT
    26.0 100000004850 10080960 Hereditary angioedema type II LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) GR (Completed) IT (Ongoing) ES (Ongoing) NL (Completed) BG (Completed) PL (Completed) PT (Completed) SK (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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