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Clinical trials

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   43387   clinical trials with a EudraCT protocol, of which   7179   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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    2,017 result(s) found. Displaying page 32 of 101.
    EudraCT Number: 2012-004867-38 Sponsor Protocol Number: NN7999-3895 Start Date*: 2015-06-08
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety and Efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophilia B An open-label single-arm multicentre non-controlled phase 3a trial investigating safety and ...
    Medical condition: Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: DE (Completed) AT (Completed) ES (Ongoing) RO (Ongoing) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-003136-25 Sponsor Protocol Number: CTD-TCNPC-301 Start Date*: 2021-10-25
    Sponsor Name:Cyclo Therapeutics, Inc.
    Full Title: A Phase 3, Double blind, Randomized, Placebo controlled, Parallel group, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of 2000 mg/kg of Trappsol® Cyclo™ (Hydroxypropyl β cycl...
    Medical condition: Niemann Pick Disease Type C1
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10029403 Niemann-Pick disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing) DE (Ongoing) PL (Ongoing) IT (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004228-41 Sponsor Protocol Number: C0251002 Start Date*: 2021-07-28
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS
    Medical condition: Dermatomyositis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012503 Dermatomyositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) HU (Completed) IT (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003467-26 Sponsor Protocol Number: NN7769-4516 Start Date*: 2021-11-30
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety, efficacy and exposure of subcutaneously administered NNC0365-3769 (Mim8) prophylaxis in children with haemophilia A with or without FVIII inhibitors
    Medical condition: Haemophilia A Haemophilia A with inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) PL (Ongoing) IT (Ongoing) ES (Ongoing) PT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003333-11 Sponsor Protocol Number: AG348-C-023 Start Date*: 2022-04-25
    Sponsor Name:Agios Pharmaceuticals, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Subjects With Pyruvate Kinase Deficiency Who Are Not Regular...
    Medical condition: Pyruvate Kinase Deficiency
    Disease: Version SOC Term Classification Code Term Level
    21.1 10010331 - Congenital, familial and genetic disorders 10037682 Pyruvate kinase deficiency anaemia PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Ongoing) FR (Ongoing) IT (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004124-10 Sponsor Protocol Number: 68284528MMY2003 Start Date*: 2020-08-07
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma
    Medical condition: Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) DE (Ongoing) BE (Ongoing) ES (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004786-25 Sponsor Protocol Number: AC-077A301 Start Date*: 2019-09-05
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of maciten...
    Medical condition: Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) PL (Ongoing) ES (Ongoing) BG (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002491-10 Sponsor Protocol Number: Alofisel-4001 Start Date*: 2020-03-10
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula
    Medical condition: Perianal fistulising Crohn´s disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10002156 Anal fistula PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Ongoing) ES (Ongoing) DE (Ongoing) FR (Ongoing) AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003855-40 Sponsor Protocol Number: MOR208C115 Start Date*: 2022-03-09
    Sponsor Name:MorphoSys AG
    Full Title: A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Ref...
    Medical condition: Diffuse Large B-Cell Lymphoma (DLBCL)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012818 Diffuse large B-cell lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) AT (Ongoing) CZ (Ongoing) IT (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000050-26 Sponsor Protocol Number: AV-951-20-304 Start Date*: 2021-11-11
    Sponsor Name:AVEO Pharmaceuticals, Inc.
    Full Title: TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma Who Have...
    Medical condition: Renal Cell Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10050076 Metastatic renal carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) CZ (Ongoing) BE (Ongoing) PL (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003680-10 Sponsor Protocol Number: AROAPOC3-3001 Start Date*: 2022-01-13
    Sponsor Name:Arrowhead Pharmaceuticals, Inc.
    Full Title: A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults with Familial Chylomicronemia Syndrome
    Medical condition: Familial Chylomicronemia Syndrome
    Disease: Version SOC Term Classification Code Term Level
    24.1 100000004850 10085051 Familial chylomicronemia syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing) IE (Ongoing) BE (Ongoing) ES (Ongoing) HR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-001829-40 Sponsor Protocol Number: 201 Start Date*: 2019-01-02
    Sponsor Name:Y-mAbs Therapeutics A/S
    Full Title: A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients with Primary Refractory Disease or Incomplete...
    Medical condition: Treatment of high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066595 Neuroblastoma recurrent PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DK (Ongoing) ES (Ongoing) DE (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003733-38 Sponsor Protocol Number: ORP-TMZ-I-b Start Date*: 2021-11-27
    Sponsor Name:ORPHELIA Pharma
    Full Title: TEMOkids study (ORP-TMZ-I- b): A Population pharmacokinetic, acceptability and safety study for KIMOZO, a paediatric oral suspension of temozolomide
    Medical condition: Different pediatric cancers such as malignant glioma and also relapsed or refractory neuroblastoma, rhabdomyosarcoma, medulloblastoma, and Ewing sarcoma, for which treatment with the cytotoxic tem...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018337 Glioblastoma multiforme PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029260 Neuroblastoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10039022 Rhabdomyosarcoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027107 Medulloblastoma PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) GB (GB - no longer in EU/EEA) DE (Ongoing) ES (Ongoing) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002987-29 Sponsor Protocol Number: BT–L-CsA–303–FU Start Date*: 2020-02-12
    Sponsor Name:Zambon SpA
    Full Title: An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they have completed the participation to BOSTON 1 and BOSTON 2 st...
    Medical condition: Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10049202 Bronchiolitis obliterans LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Ongoing) AT (Ongoing) FR (Ongoing) DK (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-006226-49 Sponsor Protocol Number: NN6019-4940 Start Date*: 2022-08-18
    Sponsor Name:Novo Nordisk A/S
    Full Title: Efficacy and safety of NNC6019-0001 at two dose levels in participants with transthyretin amyloid cardiomyopathy (ATTR CM)
    Medical condition: Transthyretin amyloid cardiomyopathy (ATTR CM)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10002020 Amyloid cardiomyopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) PT (Ongoing) DE (Ongoing) CZ (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000824-36 Sponsor Protocol Number: HLSC-UCD-01 Start Date*: 2021-12-09
    Sponsor Name:Unicyte AG
    Full Title: An open-label, controlled, multi-site, Phase I clinical trial to assess the ureagenesis capacity in newborns and infants up to the age of 12 months with neonatal and infantile onset of urea cycle d...
    Medical condition: Subject has a genetically confirmed diagnosis of any of the following urea cycle disorders: ASS, CPS1, ASL, OTC Subjects without UCD can have other stable illness that not interfere with the clini...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10080020 Urea cycle disorder PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) AT (Prematurely Ended) IT (Ongoing) BE (Completed) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-006781-21 Sponsor Protocol Number: COAV101A12308 Start Date*: 2022-10-31
    Sponsor Name:Novartis Pharma AG
    Full Title: Long-term follow-up of patients with spinal muscular atrophy Treated with OAV101 IT or OAV101 IV in Clinical Trials
    Medical condition: Spinal Muscular Atrophy
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10041582 Spinal muscular atrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Ongoing) DE (Ongoing) DK (Ongoing) ES (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000211-23 Sponsor Protocol Number: AG348-C-017 Start Date*: 2021-10-15
    Sponsor Name:Agios Pharmaceuticals, Inc.
    Full Title: A Phase 3, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Non Transfusion-Dependent Alpha- or Beta-Thalassemia (ENE...
    Medical condition: Non–Transfusion-Dependent Alpha- or Beta-Thalassemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10074356 Non-transfusion dependent thalassemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DK (Ongoing) IT (Ongoing) BG (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000212-34 Sponsor Protocol Number: AG348-C-018 Start Date*: 2021-10-11
    Sponsor Name:Agios Pharmaceuticals, Inc.
    Full Title: A Phase 3, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZ...
    Medical condition: Transfusion-Dependent Alpha- or Beta-Thalassemia
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004850 10081904 Transfusion dependent thalassemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DK (Ongoing) IT (Ongoing) BG (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-001992-35 Sponsor Protocol Number: MS200647_0055 Start Date*: 2020-04-30
    Sponsor Name:Merck Healthcare KGaA
    Full Title: A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp alfa (M7824) as First-line Treatment of Biliary Tract Cancer
    Medical condition: Biliary Tract Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028982 Neoplasm biliary tract LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073077 Intrahepatic cholangiocarcinoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10074879 Extrahepatic cholangiocarcinoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017614 Gallbladder cancer PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10034442 Periampullary carcinoma metastatic LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10034443 Periampullary carcinoma non-resectable LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10034445 Periampullary carcinoma recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Prematurely Ended) PL (Completed) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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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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