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Clinical trials for Hereditary angioedema

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    The EU Clinical Trials Register currently displays   44334   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).

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    57 result(s) found for: Hereditary angioedema. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2005-000206-31 Sponsor Protocol Number: C1 1304-01 Start Date*: 2004-06-22
    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
    9.1 10019860 Hereditary angioedema LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-024242-30 Sponsor Protocol Number: CE1145_4001 Start Date*: 2011-10-06
    Sponsor Name:CSL Behring GmbH
    Full Title: Prospective open-label uncontrolled multi-center post-marketing study to assess inhibitory antibody formation in subjects with congenital C1-INH deficiency and acute hereditary angioedema (HAE) att...
    Medical condition: congenital C1-INH deficiency and acute hereditary angioedema (HAE) attacks
    Disease: Version SOC Term Classification Code Term Level
    16.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2014-001054-42 Sponsor Protocol Number: CSL830_3002 Start Date*: 2015-03-04
    Sponsor Name:CSL Behring GmbH
    Full Title: An open-label, randomized study to evaluate the long-term clinical safety and efficacy of subcutaneous administration of human plasma-derived C1-esterase inhibitor in the prophylactic treatment of ...
    Medical condition: Hereditary Angioedema Types I and II
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) HU (Completed) CZ (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-001186-17 Sponsor Protocol Number: CE1145_3001 Start Date*: 2005-09-05
    Sponsor Name:ZLB Behring GmbH
    Full Title: Human pasteurized C1 esterase inhibitor concentrate (CE1145) in subjects with congenital C1-INH deficiency and acute abdominal or facial HAE attacks
    Medical condition: Hereditary angioedema (HAE) is characterized by congenital C1-INH deficiency. This is reflected by insufficient plasma concentrations of C1 – inhibitor or by synthesis of dysfunctional C1 – inhibit...
    Disease: Version SOC Term Classification Code Term Level
    7.0 10019860 LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) GB (Completed) ES (Completed) CZ (Completed) SE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2013-000916-10 Sponsor Protocol Number: CSL830_3001 Start Date*: 2013-12-10
    Sponsor Name:CSL Behring GmbH
    Full Title: A double-blind, randomized, placebo-controlled, cross-over study to evaluate the clinical efficacy and safety of subcutaneous administration of human plasma-derived C1-esterase inhibitor in the pro...
    Medical condition: Hereditary Angioedema (HAE) type I and II
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) IT (Completed) ES (Completed) CZ (Completed)
    Trial results: View results
    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 (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-001693-28 Sponsor Protocol Number: CONE-01 Start Date*: 2020-02-06
    Sponsor Name:Octapharma Pharmazeutika Produktionsges.m.b.H.
    Full Title: Prospective, open-label, single arm, multicenter, pharmacokinetic, and safety study of a single dose intravenous human plasma-derived C1 Esterase Inhibitor (C1-INH) concentrate in patients with con...
    Medical condition: Hereditary angioedema type I and type II
    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 10080960 Hereditary angioedema type II LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002453-29 Sponsor Protocol Number: 0624-301 Start Date*: 2014-03-05
    Sponsor Name:Shire ViroPharma Incorporated
    Full Title: A PHASE 3, MULTICENTER, RANDOMIZED, SINGLE-BLIND, DOSE-RANGING, CROSSOVER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVENOUS ADMINISTRATION OF CINRYZE® (C1 ESTERASE INHIBITOR [HUMAN]) FOR THE...
    Medical condition: Prevention of angioedema attacks in children 6 to 11 years of age with hereditary angioedema.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2011-000987-92 Sponsor Protocol Number: C11209 Start Date*: 2011-09-26
    Sponsor Name:Pharming Technologies B.V.
    Full Title: Open-label, phase II, single arm study to evaluate the safety, immunogenicity, pharmacokinetics and efficacy of recombinant human C1 inhibitor for the treatment of acute attacks in pediatric patien...
    Medical condition: Attacks associated with hereditary angioedema (HAE) in pediatric population 2-13 years of age.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) CZ (Completed) SK (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2017-003281-27 Sponsor Protocol Number: BCX7353-204 Start Date*: 2017-12-27
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: An Open-Label study to Evaluate the Long-Term Safety of Daily Oral BCX7353 in subjects with Type I and II 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: GB (GB - no longer in EU/EEA) DE (Completed) HU (Completed) DK (Completed) AT (Completed) ES (Completed) SK (Completed) PL (Completed) BE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000605-24 Sponsor Protocol Number: CSL312_2001 Start Date*: 2018-12-20
    Sponsor Name:CSL Behring LLC
    Full Title: A multicenter, randomized, placebo-controlled, parallel-arm study to investigate the efficacy, pharmacokinetics, and safety of CSL312 in subjects 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: DE (Completed)
    Trial results: View results
    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 (Trial now transitioned) CZ (Trial now transitioned) HU (Trial now transitioned) 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 (Completed) CZ (Trial now transitioned) SK (Trial now transitioned) PL (Trial now transitioned)
    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 (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000570-25 Sponsor Protocol Number: CSL312_3001 Start Date*: 2021-02-09
    Sponsor Name:CSL Behring LLC
    Full Title: A multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic tr...
    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 (Completed) HU (Completed) NL (Completed) IT (Ongoing)
    Trial results: View results
    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: 2005-003819-71 Sponsor Protocol Number: DX-88/14 Start Date*: 2006-11-23
    Sponsor Name:Dyax Corp
    Full Title: EDEMA3: Evaluation of DX-88’s Effects in Mitigating Angioedema A double-blind, placebo-controlled study followed by a repeat dosing phase to assess the efficacy and safety of DX-88 (recombinant pl...
    Medical condition: Hereditary Angioedema
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-022716-39 Sponsor Protocol Number: DX-88/26 Start Date*: Information not available in EudraCT
    Sponsor Name:Dyax Corp.
    Full Title: A 3-Part Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Subcutaneous Ecallantide in Prepubertal Paediatric Patients Experiencing Acute Attacks of Hereditary Angioedema
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    12.1 10019860 Hereditary angioedema LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002478-19 Sponsor Protocol Number: SHP616-300 Start Date*: 2016-06-28
    Sponsor Name:Shire ViroPharma, Inc.
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Two-period, Three-sequence, Partial Crossover Study to Evaluate the Efficacy and Safety of Subcutaneous Administration of 2000 IU of C1 Este...
    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: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2005-003139-38 Sponsor Protocol Number: CE1145_3003 Start Date*: 2015-02-12
    Sponsor Name:ZLB Behring GmbH
    Full Title: Open-label extension study of CE1145 (Human pasteurized C1 esterase inhibitor concentrate) in subjects with congenital C1-INH deficiency and acute HAE attacks
    Medical condition: Congenital C1-INH deficiency
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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