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Clinical trials for Breakthrough Bleeding

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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    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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    49 result(s) found for: Breakthrough Bleeding. Displaying page 1 of 3.
    1  2  3  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: 2012-002459-41 Sponsor Protocol Number: P012-00 Start Date*: 2012-11-29
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A multicenter, randomized, partially-blinded, Phase IIb dose-finding study on ovarian function, vaginal bleeding pattern, and pharmacokinetics associated with the use of combined vaginal rings rele...
    Medical condition: This is the dose-finding study on ovarian function, vaginal bleeding pattern, and pharmacokinetics associated with the use of combined vaginal rings in healthy women
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038604 - Reproductive system and breast disorders 10046883 Vaginal bleeding LLT
    Population Age: Adults Gender: Female
    Trial protocol: NO (Completed) DE (Completed) SE (Completed) NL (Completed) HU (Completed) ES (Completed) DK (Completed) PL (Completed)
    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: 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: 2004-000443-17 Sponsor Protocol Number: NV-02B-011 Start Date*: 2004-09-26
    Sponsor Name:Idenix Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-Blind Trial of Telbivudine (LdT) versus Lamivudine in Adults with Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
    Medical condition: Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2012-003093-98 Sponsor Protocol Number: Ten02 Start Date*: 2015-02-24
    Sponsor Name:Bio Products Laboratory Limited
    Full Title: A Phase III Open, Multicentre Study to Confirm the Safety, Pharmacokinetics and Efficacy of BPL’s High Purity Factor X in the Prophylaxis of Bleeding in Factor X Deficient Children Under the Age of...
    Medical condition: Factor X Deficiency
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-003027-15 Sponsor Protocol Number: EFFI2021/01 Start Date*: 2023-03-20
    Sponsor Name:ITALFARMACO S.P.A.
    Full Title: A multicentre, prospective, open-label, non-comparative study to evaluate menstrual bleeding typology, tolerability, and compliance during a monophasic hormonal contraceptive treatment with norgest...
    Medical condition: Combined Oral Contraceptives (COC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10014698 Endocrine disorders SOC
    Population Age: Adults Gender: Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-005304-16 Sponsor Protocol Number: 292001 Start Date*: 2006-06-09
    Sponsor Name:NV Organon
    Full Title: A randomized, open-label, comparative, multi-center trial to evaluate contraceptive efficacy, cycle control, safety and acceptability of a monophasic combined oral contraceptive (COC) containing 2....
    Medical condition: Hormonal oral contraception in healthy women
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed) SE (Completed) DK (Completed) FI (Completed) BE (Completed) DE (Completed) ES (Completed) CZ (Completed) GB (Completed) IT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2013-005159-34 Sponsor Protocol Number: IG1103 Start Date*: 2014-06-16
    Sponsor Name:Instituto Grifols, S.A.
    Full Title: A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Soft Tissue Open Surgeries
    Medical condition: Treatment of haemorrhage resulting from soft tissue surgical procedure
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2013-005127-16 Sponsor Protocol Number: IG1101 Start Date*: 2014-06-16
    Sponsor Name:Instituto Grifols, S.A.
    Full Title: A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis during Peripheral Vascular Surgery
    Medical condition: Treatment of haemorrhage resulting from a vascular surgical procedure
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2013-005128-40 Sponsor Protocol Number: IG1102 Start Date*: 2014-06-16
    Sponsor Name:Instituto Grifols, S.A.
    Full Title: A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Parenchymous Tissue Open Surge...
    Medical condition: Treatment of haemorrhage resulting from parenchymous tissue surgical procedure
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2020-005916-23 Sponsor Protocol Number: ML39791 Start Date*: 2020-12-18
    Sponsor Name:Genentech, Inc.
    Full Title: A Phase IV, Multicenter, Single-Arm, Open-Label Study of Emicizumab Prophylaxis in Patients With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures
    Medical condition: Hemophilia A with or without inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10053753 Hemophilia A without inhibitors LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-005100-41 Sponsor Protocol Number: IB1001-01 Start Date*: 2009-03-16
    Sponsor Name:Aptevo Europe Limited
    Full Title: Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects with Haemophilia B
    Medical condition: Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) FR (Ongoing) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001556-35 Sponsor Protocol Number: GENA-21 Start Date*: 2013-07-26
    Sponsor Name:Octapharma AG
    Full Title: Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of individually tailored prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe hae...
    Medical condition: Severe haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) SK (Completed) CZ (Completed) HU (Completed) BG (Completed) AT (Completed) ES (Prematurely Ended) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-018644-14 Sponsor Protocol Number: GENA-03 Start Date*: 2010-11-16
    Sponsor Name:Octapharma AG
    Full Title: PROSPECTIVE CLINICAL STUDY IN CHILDREN WITH SEVERE HAEMOPHILIA A TO INVESTIGATE CLINICAL EFFICACY, IMMUNOGENICITY, PHARMACOKINETICS, AND SAFETY OF HUMAN-CL RHFVIII
    Medical condition: Severe Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    12.1 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: DE (Completed) AT (Completed) CZ (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-002208-26 Sponsor Protocol Number: MK-8342B-062 Start Date*: 2015-10-23
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.
    Full Title: A Phase 3, randomized, active-comparator controlled clinical trial to study the contraceptive efficacy and safety of the MK-8342B (etonogestrel + 17β-estradiol) vaginal ring and the levonorgestrel-...
    Medical condition: Contraception
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NO (Completed) SE (Completed) DE (Prematurely Ended) FI (Prematurely Ended) DK (Prematurely Ended) AT (Completed) ES (Completed) NL (Completed) HU (Completed) PL (Prematurely Ended) CZ (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-004155-32 Sponsor Protocol Number: 3090A1-301 Start Date*: 2015-04-06
    Sponsor Name:Wyeth Research
    Full Title: An Open-Label, Single-Arm, Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX ) in Children Less Than 6 Years of Age With Severe Hemophilia B
    Medical condition: Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001445-40 Sponsor Protocol Number: GreenGeneF_P3 Start Date*: 2013-01-09
    Sponsor Name:Green Cross Corporation
    Full Title: Determination of Safety, Efficacy, and Pharmacokinetics of GreenGene™ F in Previously Treated Patients 12 years of age or older Diagnosed with Severe Hemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10018937 Haemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) PL (Prematurely Ended) HR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-002986-30 Sponsor Protocol Number: GENA-21b Start Date*: 2015-05-07
    Sponsor Name:OCTAPHARMA AG
    Full Title: Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of personalized prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe haemophilia A
    Medical condition: Severe Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Completed) NL (Completed) FI (Completed) SI (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2013-004025-88 Sponsor Protocol Number: NN7088-3908 Start Date*: 2014-04-28
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety and Efficacy of turoctocog alfa pegol (N8-GP) in Previously Untreated Patients with Haemophilia A An open-label single-arm multicentre non-controlled phase 3a trial investigating safety a...
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: DE (Completed) AT (Completed) ES (Temporarily Halted) PT (Ongoing) GR (Completed) BG (Completed) RO (Ongoing) IT (Completed) FR (Ongoing)
    Trial results: View results
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