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Clinical trials for ABR

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   44335   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    103 result(s) found for: ABR. Displaying page 1 of 6.
    1  2  3  4  5  6  Next»
    EudraCT Number: 2020-003304-13 Sponsor Protocol Number: TAK-577-3001 Start Date*: Information not available in EudraCT
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis with rVWF in Children Diagnosed With Severe von Willebrand disease
    Medical condition: severe von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IE (Trial now transitioned) NO (Completed) SE (Prematurely Ended) ES (Trial now transitioned) FR (Trial now transitioned) AT (Prematurely Ended) NL (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-002023-15 Sponsor Protocol Number: EFC16293 Start Date*: 2020-02-25
    Sponsor Name:Bioverativ Therapeutics Inc. (a Sanofi company)
    Full Title: Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTE...
    Medical condition: severe hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10016080 Factor VIII deficiency PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) BG (Completed) BE (Completed) GR (Completed) HU (Completed) NL (Completed) ES (Completed) Outside EU/EEA IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-004451-37 Sponsor Protocol Number: C3731003 Start Date*: 2021-09-24
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants with Moderately Severe to Sev...
    Medical condition: hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) IT (Completed) ES (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2014-005477-37 Sponsor Protocol Number: 261303 Start Date*: 2016-01-26
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: Phase 3, prospective, randomized, multi-center clinical study comparing the safety and efficacy of BAX 855 following PK-guided prophylaxis targeting two different FVIII trough levels in subjects wi...
    Medical condition: Severe hemophilia A (FVIII <1%)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) AT (Completed) SE (Completed) CZ (Prematurely Ended) ES (Completed) HU (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001478-14 Sponsor Protocol Number: 071301 Start Date*: Information not available in EudraCT
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASE
    Medical condition: Hereditary severe von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    19.0 10010331 - Congenital, familial and genetic disorders 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) CZ (Completed) NL (Completed) ES (Completed) DE (Completed) FI (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-004321-16 Sponsor Protocol Number: CCOA566A2417 Start Date*: 2017-08-31
    Sponsor Name:Novartis Pharma AG
    Full Title: A study of the effects of Coartem, Malarone and artesunate-mefloquine on auditory function in patients 12 years of age or older with acute uncomplicated P. falciparum malaria
    Medical condition: This study assessed the effects of artemether-lumefantrine on the auditory nerve pathway as assessed by Auditory Brainstem Response (ABR) and audiometric testing in acute uncomplicated Plasmodium f...
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-004480-48 Sponsor Protocol Number: 20446 Start Date*: 2021-12-14
    Sponsor Name:Bayer AG
    Full Title: A prospective, lead-in study to collect bleeding episodes, Factor VIII (FVIII) infusions, and patient-reported outcomes in patients with hemophilia A
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: ES (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002236-24 Sponsor Protocol Number: 261302 Start Date*: 2014-03-27
    Sponsor Name:Baxter Innovations GmbH
    Full Title: A Phase 3b Continuation study of the Safety and Efficacy of PEGylated Recombinant Factor VIII (PEG-rFVIII; BAX 855) in Prophylaxis of Bleeding in Previously Treated Patients with Severe Hemophilia A
    Medical condition: Severe hemophilia A (FVIII <1%)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: BE (Completed) LT (Completed) BG (Completed) SE (Completed) GB (Completed) CZ (Completed) AT (Completed) NL (Completed) DE (Completed) ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2006-005533-38 Sponsor Protocol Number: ABR 14828 Start Date*: 2007-06-28
    Sponsor Name:there is no sponsor.
    Full Title: 'Studies in patients with chronic cough; montelukast and amitriptyline studies’.
    Medical condition: Chronic cough ( cough lasting > 8 weeks).
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-000079-38 Sponsor Protocol Number: DB-OTO-001 Start Date*: 2023-05-09
    Sponsor Name:Decibel Therapeutics
    Full Title: A Phase 1/2, Open-Label, Multicenter Trial With a Single Ascending Dose Cohort With Unilateral Intracochlear Injection Followed by a Bilateral Injection Expansion Cohort to Evaluate the Safety, Tol...
    Medical condition: Congenital auditory neuropathy secondary to biallelic mutations of the otoferlin gene (hOTOF)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004854 10011874 Deaf LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2023-000502-26 Sponsor Protocol Number: TAK-660-3001 Start Date*: 2025-02-13
    Sponsor Name:Baxalta US Inc.
    Full Title: A Phase 3, Prospective, Multicenter, Open-label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (ADYNOVATE) Administered for Prophylaxis and Treatment of Bleedi...
    Medical condition: Severe Hemophilia A (FVIII <1%)
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-003660-31 Sponsor Protocol Number: B7841005 Start Date*: 2020-09-07
    Sponsor Name:Pfizer Inc.
    Full Title: An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A or B Patients With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis
    Medical condition: Hemophilia A or B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000004850 10060612 Hemophilia A LLT
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended) FR (Completed) BG (Completed) GB (GB - no longer in EU/EEA) ES (Restarted) IE (Completed) HR (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003453-16 Sponsor Protocol Number: SHP677-304 Start Date*: 2019-07-31
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD)
    Medical condition: severe von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) DE (Completed) ES (Completed) AT (Completed) IT (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003537-11 Sponsor Protocol Number: 19855 Start Date*: 2024-03-14
    Sponsor Name:Bayer Healthcare Company Limited
    Full Title: A Post Approval Commitment study to evaluate the efficacy, safety, and pharmacokinetics of KOVALTRY in Chinese children, adolescents/adults with severe hemophilia A.
    Medical condition: KOVALTRY, indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for: - Routine prophylaxis to reduce the frequency of bleeding episodes - On-demand treatmen...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    20.0 10042613 - Surgical and medical procedures 10071818 Bleeding prophylaxis LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-004210-33 Sponsor Protocol Number: SIG-001-121 Start Date*: 2020-06-11
    Sponsor Name:Sigilon Therapeutics, Inc.
    Full Title: A Phase 1/2 Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of SIG-001 in Adult Patients with Severe or Moderately-Severe Haemophilia A Without Inhibitors
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018937 Haemophilia A LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-002026-22 Sponsor Protocol Number: NEOPREMEC Start Date*: 2013-10-24
    Sponsor Name:ErasmusMC
    Full Title: Rectal and oral omeprazole treatment of gastroesophageal reflux in infants with esophageal atresia or congenital diaphragmatic hernia. A pharmacodynamic and pharmacokinetic study
    Medical condition: GORD,
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002911-16 Sponsor Protocol Number: na Start Date*: 2016-12-28
    Sponsor Name:Maastricht University Medical Center
    Full Title: PET/MRI and plaque vulnerability A feasibility study of 18F-Flutemetamol in atherosclerosis
    Medical condition: Atherosclerosis in the carotids and coronary arteries.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-001463-36 Sponsor Protocol Number: EFC14768 Start Date*: 2018-07-25
    Sponsor Name:Genzyme Corporation
    Full Title: ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX
    Medical condition: Hemophilia A or Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) BG (Completed) HU (Completed) ES (Prematurely Ended) PT (Completed) FR (Completed) DE (Completed) DK (Completed) NL (Not Authorised) IT (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001464-11 Sponsor Protocol Number: ALN-AT3SC-004 Start Date*: Information not available in EudraCT
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: ATLAS-A/B: A Phase 3 study to evaluate the efficacy and safety of fitusiran in patients with hemophilia A or B, without inhibitory antibodies to factor VIII or IX
    Medical condition: Hemophilia A or Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000011913 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: IE (Prematurely Ended) BG (Completed) HU (Completed) ES (Prematurely Ended) PT (Completed) FR (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) NL (Not Authorised) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-000769-18 Sponsor Protocol Number: EFC16295 Start Date*: Information not available in EudraCT
    Sponsor Name:Bioverativ Therapeutics Inc.
    Full Title: A Phase 3 open-label, multicenter study of the safety, efficacy, and pharmacokinetics of intravenous recombinant coagulation Factor VIII Fc-von Willebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-X...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: DE (Completed) FR (Completed) IE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) SE (Completed) HU (Completed) NL (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
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