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Clinical trials for Laboratory safety

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   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).

    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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    10,756 result(s) found for: Laboratory safety. Displaying page 1 of 538.
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    EudraCT Number: 2018-000904-40 Sponsor Protocol Number: AN2728-AD-303 Start Date*: 2018-07-23
    Sponsor Name:Pfizer Inc.
    Full Title: A Multicenter, Open-Label Study Of The Long-Term Safety Of AN2728 Topical Ointment, 2% In The Treatment Of Children, Adolescents, And Adults (Ages 2 Years And Older) With Atopic Dermatitis
    Medical condition: Atopic Dermatitis
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005805-35 Sponsor Protocol Number: ARRAY-818-302 Start Date*: 2016-11-28
    Sponsor Name:Array BioPharma Inc.
    Full Title: A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA) /Irino...
    Medical condition: BRAF V600E-mutant Metastatic Colorectal Cancer
    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
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) BE (Completed) AT (Completed) NL (Completed) CZ (Completed) DK (Completed) ES (Ongoing) NO (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-004881-16 Sponsor Protocol Number: VX19-864-101 Start Date*: 2020-10-29
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of VX-864 in PiZZ Subjects
    Medical condition: Alpha 1 antitrypsin deficiency in Subjects With the PiZZ Genotype
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10083869 Alpha-1 antitrypsin deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) DE (Completed) SE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2017-000239-15 Sponsor Protocol Number: SFY10717 Start Date*: 2017-03-20
    Sponsor Name:Sanofi
    Full Title: An open-label, uncontrolled 4-week study to assess the safety, efficacy and pharmacokinetics of Allegra® (dry syrup formulation) 15 mg or 30 mg twice daily in pediatric patients with perennial all...
    Medical condition: Rhinitis perennial
    Disease: Version SOC Term Classification Code Term Level
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10039094 Rhinitis perennial PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-007346-63 Sponsor Protocol Number: ALS-003-2008 Start Date*: 2011-04-05
    Sponsor Name:Alloksys Life Sciences B.V.
    Full Title: Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients
    Medical condition: Rheumatoid Arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2006-001375-38 Sponsor Protocol Number: RNOP-09 Start Date*: 2006-08-30
    Sponsor Name:Klinik und Poliklinik für Neurologie der Universität Regensburg am Bezirksklinikum
    Full Title: Temozolomide and pegylated (PEG)-liposomal Doxorubicin in first line treatment of patients with Glioblastoma WHO Grad IV
    Medical condition: newly diagnosed Glioblastoma multiforme WHO Grade IV
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-004445-10 Sponsor Protocol Number: CVAL489K1101 Start Date*: 2016-06-07
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age.
    Medical condition: Hypertension, Chronic Kidney Disease, Nephrotic Syndrome
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-001894-26 Sponsor Protocol Number: CP-PRO-QVLP-014 Start Date*: 2018-10-18
    Sponsor Name:Medicago R&D Inc.
    Full Title: A Randomized, Observer-blind, Active Comparator-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-derived Quadrivalent VLP Influenza Vaccine in Ad...
    Medical condition: Seasonal influenza
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2020-001288-99 Sponsor Protocol Number: C4221015 Start Date*: 2020-11-26
    Sponsor Name:Pfizer Inc.
    Full Title: AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND C...
    Medical condition: Colorectal cancer (BRAF V600E-mutant mCRC)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Ongoing) DE (Ongoing) FR (Not Authorised) BE (Trial now transitioned) SE (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned) SK (Trial now transitioned) BG (Trial now transitioned) FI (Trial now transitioned) DK (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-002520-13 Sponsor Protocol Number: 251602 Start Date*: 2022-07-18
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: Phase IV Multi-center, Prospective, Interventional, Post-marketing Study in Hemophilia B Patients in India receiving RIXUBIS as On-demand or Prophylaxis Under Standard Clinical Practice
    Medical condition: Hemophilia B
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-002452-37 Sponsor Protocol Number: IMG-7289-CTP-202 Start Date*: 2022-01-27
    Sponsor Name:Imago BioSciences Inc.
    Full Title: A Multi-Center, Open Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Patients with Myeloproliferative Neoplasms (MPNs) Enrolled in a Prior Bomedemstat ...
    Medical condition: Patients with Myeloproliferative Neoplasms (MPNs)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077465 Myeloproliferative neoplasm PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001845-15 Sponsor Protocol Number: TINCRBEL_study Start Date*: 2018-07-13
    Sponsor Name:Academic medical centre, department of internal medicine
    Full Title: EvaluaTion of Clinical and laboratory outcomes of Rivaroxaban in short Bowel syndrome patients dEpending on Long term parenteral nutrition: a prospective cohort study (TINCRBEL study)
    Medical condition: Chronic intestinal failuyre (IF) is caused by large surgical bowel resection, severe motility, or absorption diseorders. These patientds require partial or total parenteral nutrition (PN and TPN, r...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-002014-39 Sponsor Protocol Number: RTB-101-205 Start Date*: 2019-08-30
    Sponsor Name:resTORbio, Inc.
    Full Title: A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
    Medical condition: Clinically Symptomatic Respiratory Illness in the Elderly
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-003536-12 Sponsor Protocol Number: CIGE025B1301E1 Start Date*: 2016-02-16
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: An Extension Study to CIGE025B1301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Asthma Despite...
    Medical condition: Allergic Asthma
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-005903-11 Sponsor Protocol Number: C4591017 Start Date*: 2022-01-20
    Sponsor Name:BioNTech SE
    Full Title: A Phase 3, Randomized, Observer-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of The Vaccine Candidate BNT162b2 Against COVID-19 i...
    Medical condition: SARS-CoV-2 Infection
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003650-92 Sponsor Protocol Number: VX19-814-101 Start Date*: 2020-02-11
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of VX-814 in PiZZ Subjects
    Medical condition: Alpha-1 Antitrypsin Deficiency
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) SE (Prematurely Ended) GB (Prematurely Ended) IE (Completed)
    Trial results: View results
    EudraCT Number: 2019-002758-21 Sponsor Protocol Number: DTCI-PIT-001 Start Date*: Information not available in EudraCT
    Sponsor Name:Innovative Diabetes Treatments Studies LLC
    Full Title: PILOT STUDY FOR EVALUATION OF THE IMPACT OF PULSATILE INSULIN INFUSION THERAPY ON VASCULAR FUNCTION IN PATIENTS WITH TYPE 1 AND TYPE 2 DIABETES MELLITUS
    Medical condition: treatment of long-term effects of Diabetes Type 1 and Type 2
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-003004-31 Sponsor Protocol Number: NP25139 Start Date*: 2016-08-09
    Sponsor Name:F. Hoffmann-La Roche AG
    Full Title: An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir (Tamiflu) in the Treatment of Children 1 to 12 Years of Age With Influenza Infection
    Medical condition: Influenza
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003353-16 Sponsor Protocol Number: GS-US-339-1559 Start Date*: 2017-04-18
    Sponsor Name:Gilead Sciences, Inc
    Full Title: A Phase 1b/2 Study of Entospletinib (GS-9973) Monotherapy and in Combination with Chemotherapy in Patients with Acute Myeloid Leukemia (AML)
    Medical condition: Acute Myeloid Leukemia (AML)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-024247-32 Sponsor Protocol Number: 1263-203 Start Date*: 2012-03-09
    Sponsor Name:VIROPHARMA INCORPORATED
    Full Title: A PHASE 2, RANDOMIZED, DOSE-RANGING STUDY TO ASSESS THE SAFETY AND ANTI-CYTOMEGALOVIRUS (CMV) ACTIVITY OF MARIBAVIR VERSUS VALGANCICLOVIR FOR TREATMENT OF CMV INFECTIONS IN TRANSPLANT RECIPIENTS WH...
    Medical condition: CMV INFECTIONS IN TRANSPLANT RECIPIENTS
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10021819 Infection in marrow transplant recipients LLT
    14.1 100000004862 10021829 Infection in solid organ transplant recipients LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) FR (Completed) AT (Completed) ES (Completed) GB (Completed)
    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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