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Clinical trials for Complement 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
  • 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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    68 result(s) found for: Complement Deficiency. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2006-006023-39 Sponsor Protocol Number: BI 3023_2001 Start Date*: 2007-09-24
    Sponsor Name:CSL Behring GmbH
    Full Title: Pharmacokinetics of Haemocomplettan P in subjects with congenital fibrinogen deficiency
    Medical condition: PK study in patient with afibrinogemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016075 Factor I deficiency LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-001280-30 Sponsor Protocol Number: FGT1-A616 Start Date*: 2007-06-20
    Sponsor Name:LFB SA
    Full Title: INTERNATIONAL NON -CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF FIBRINOGENE T-I IN ADOLESCENTS AND ADULTS WITH AFIBRINOGENAEMIA OR SEVERE HYPOFIBRINOGENAEMIA UNDERGOING SURGERY
    Medical condition: Surgical procedures in patients with afibrinogenaemia and severe hypofibrinogenaemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052651 Afibrinogenaemia LLT
    9.1 10051125 Hypofibrinogenaemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-002403-15 Sponsor Protocol Number: Forma-01 Start Date*: 2012-08-07
    Sponsor Name:OCTAPHARMA AG
    Full Title: A prospective, controlled, randomised, cross-over study investigating the pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/ RiaSTAPTM in subjec...
    Medical condition: congenital fibrinogen deficiency
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004850 10052651 Afibrinogenaemia LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004005-81 Sponsor Protocol Number: GC1801 Start Date*: 2021-01-25
    Sponsor Name:Instituto Grifols, S.A.
    Full Title: A prospective, multicenter, open-label, single-arm study to evaluate the efficacy and safety of human plasma-derived fibrinogen concentrate (FIB Grifols) in subjects with congenital afibrinogenaemi...
    Medical condition: Congenital Afibrinogenaemia and Severe Hypofibrinogenemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10052651 Afibrinogenaemia LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-004088-22 Sponsor Protocol Number: BI 3023_3001 Start Date*: 2009-09-22
    Sponsor Name:CSL BEHRING GmbH
    Full Title: Efficacy and safety of Fibrinogen Concentrate (Human) for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency
    Medical condition: Congenital fibrinogen deficiency ( afibrinogenemia, severe hypofibrinogenemia)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016075 LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-000261-36 Sponsor Protocol Number: FGTW-1004 Start Date*: 2013-11-29
    Sponsor Name:LFB Biotechnologies
    Full Title: Clinical pharmacology, efficacy and safety study of FGTW in paediatric patients with severe congenital fibrinogen deficiency
    Medical condition: Afibrinogenaemia or severe hypofibrinogenaemia
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10052651 Afibrinogenaemia LLT
    16.1 10005329 - Blood and lymphatic system disorders 10051125 Hypofibrinogenaemia PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-004154-25 Sponsor Protocol Number: 984 Start Date*: 2013-06-25
    Sponsor Name:Biotest AG
    Full Title: A prospective, open-label, phase I/II study investigating pharmacokinetic properties of BT524 and efficacy and safety of BT524 in the treatment and prophylaxis of bleeding in patients with congenit...
    Medical condition: Patients with congenital afibrinogenemia or severe congenital hypofibrinogenemia.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10016075 Factor I deficiency PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) DE (Completed) BG (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
    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: 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: 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: 2019-003213-34 Sponsor Protocol Number: 270-205 Start Date*: 2020-09-25
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 1/2 Safety, Tolerability, and Efficacy Study of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Active or Prior Inhibitors
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Ongoing) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002454-78 Sponsor Protocol Number: V72_62 Start Date*: 2014-02-18
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine when administered to Immunoco...
    Medical condition: Meningococcal Group B disease.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed) PL (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: 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: 2021-003603-18 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: 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: 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: 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: 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
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