Flag of the European Union EU Clinical Trials Register Help

Clinical trials for No Observed Adverse Effect Level

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    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.
    Advanced Search: Search tools
     
    99 result(s) found for: No Observed Adverse Effect Level. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2021-000171-36 Sponsor Protocol Number: C20-54 Start Date*: 2021-03-23
    Sponsor Name:INSERM
    Full Title: PHASE I-II EFFICACY-TOXICITY OF ARTESUNATE IN FRIEDREICH ATAXIA
    Medical condition: Friedreich Ataxia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10017374 Friedreich's ataxia PT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-006338-32 Sponsor Protocol Number: WA21493 Start Date*: 2008-05-06
    Sponsor Name:Hoffman La Roche Ltd
    Full Title: Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 do...
    Medical condition: Relapsing remitting multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063399 Relapsing-remitting multiple sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) DE (Completed) ES (Completed) CZ (Completed) SK (Completed) DK (Completed) BE (Completed) NL (Completed) FI (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002046-71 Sponsor Protocol Number: CLIK066X2204 Start Date*: 2017-10-20
    Sponsor Name:Novartis Pharma AG
    Full Title: A 12-week randomized, patient and investigator blinded, placebo-controlled, parallel group study to investigate the efficacy of LIK066 in obese patients with non-alcoholic steatohepatitis (NASH)
    Medical condition: obese patients with non-alcoholic steatohepatitis (NASH)
    Disease: Version SOC Term Classification Code Term Level
    22.0 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-004991-31 Sponsor Protocol Number: INCB24360-301/MK3475-252/Keynote252 Start Date*: 2016-05-03
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combination With Epacadostat or Placebo in Subjects with Unresectable or Metastatic Melanoma (Keynote-252 ...
    Medical condition: Melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10053571 Melanoma LLT
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) NL (Completed) DK (Completed) IE (Completed) ES (Completed) PL (Completed) FR (Completed) BE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-000297-72 Sponsor Protocol Number: 2-55-52030-727 Start Date*: 2007-04-24
    Sponsor Name:BEAUFOUR IPSEN Pharma
    Full Title: Phase III, multicentre, open study to assess the efficacy and safety profiles of the co-administration of lanreotide Autogel 120 mg (administered via deep subcutaneous injections every 28 days) and...
    Medical condition: Acromegaly
    Disease: Version SOC Term Classification Code Term Level
    8.1 10000599 Acromegaly LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GR (Completed) DE (Completed) CZ (Completed) DK (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2022-002323-35 Sponsor Protocol Number: TAK-669-3001 Start Date*: 2022-11-10
    Sponsor Name: Takeda Development Center Americas, Inc.
    Full Title: A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Velaglucerase Alfa in Chinese Subjects With Type 1 Gaucher Disease
    Medical condition: Type 1 Gaucher Disease
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2018-002093-42 Sponsor Protocol Number: SHP643-301 Start Date*: 2020-02-04
    Sponsor Name:Shire (Shire is now part of Takeda)
    Full Title: SPRING STUDY: An Open-Label, Multicenter, Phase 3 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab for Prevention Against Acute Attacks of Hereditary Angioedema (...
    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
    23.1 10010331 - Congenital, familial and genetic disorders 10075280 Hereditary angioedema attack LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) ES (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-003598-33 Sponsor Protocol Number: LJ401-HH01 Start Date*: 2018-04-03
    Sponsor Name:La Jolla Pharmaceutical Company
    Full Title: A Phase 2, Multi-center, Randomized, Placebo-controlled, Single-blind Study with LJPC-401 for the Treatment of Iron Overload in Adult Patients with Hereditary Hemochromatosis
    Medical condition: Hereditary Hemochromatosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10027433 Metabolism and nutrition disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-002947-32 Sponsor Protocol Number: 02GPR2021 Start Date*: 2021-10-28
    Sponsor Name:Celon Pharma SA
    Full Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety and Pharmacokinetics after 2-weeks Administration of CPL207280 (GPR40 agonist) in Subjects...
    Medical condition: Type 2 Diabetes
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003772-14 Sponsor Protocol Number: GN43271 Start Date*: 2021-11-18
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE EFFICACY OF FENEBRUTINIB IN RELAPSING MULTIPLE SCLEROSIS
    Medical condition: Relapsing Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    21.0 10029205 - Nervous system disorders 10080700 Relapsing multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Ongoing) SK (Ongoing) HR (Ongoing)
    Trial results: View results
    EudraCT Number: 2005-001166-13 Sponsor Protocol Number: COU-AA-001 Start Date*: 2005-09-21
    Sponsor Name:Cougar Biotechnology, Inc
    Full Title: A Phase I/II Open Label Study of the 17α-hydroxylase/ C17,20 lyase inhibitor, Abiraterone acetate, in Patients with Prostate Cancer who have failed hormone therapy
    Medical condition: Hormone refractory prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    8.0 10062904
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-003494-26 Sponsor Protocol Number: Florence-PROTEST Start Date*: 2012-10-26
    Sponsor Name:AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
    Full Title: EVALUATION OF THE EFFECT OF TESTOSTERONE REPLACEMENT THERAPY ON PROSTATIC INFLAMMATION AND LOWER URINARY TRACT SYMPTOMS IN HYPOGONADAL SUBJECTS
    Medical condition: metabolic syndrome and BPH patients who will undergo simple prostatectomy
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004872 10004447 Benign prostatic hypertrophy LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003099-10 Sponsor Protocol Number: DCR-PHXC-301 Start Date*: 2019-06-12
    Sponsor Name:Dicerna Pharmaceuticals Inc
    Full Title: An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria
    Medical condition: Primary Hyperoxaluria
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10020703 Hyperoxaluria PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) GB (GB - no longer in EU/EEA) DE (Ongoing) NL (Ongoing) ES (Ongoing) PL (Completed) IT (Ongoing) RO (Completed) NO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004012-19 Sponsor Protocol Number: PRN1008-010(DFI17124) Start Date*: 2018-03-12
    Sponsor Name:Principia Biopharma, a Sanofi Company
    Full Title: An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of Rilzabrutinib (PRN1008), an Oral BTK Inhibitor, in Patients with Relapsed...
    Medical condition: Immune Thrombocytopenia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) BG (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-005000-17 Sponsor Protocol Number: JU-BioMiStem-01 Start Date*: 2021-09-20
    Sponsor Name:Jagiellonian University
    Full Title: A Randomized, Double Blind, Two Arms, Controlled Phase I/II Safety and Efficacy Study on MesoCellA-Ortho Tissue Engineered Product Intraarticularly Administrated in Adult Patients with Osteoarthrosis
    Medical condition: articular knee diseases
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10023476 Knee osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002635-41 Sponsor Protocol Number: 15HI53 Start Date*: 2018-09-26
    Sponsor Name:Great Ormond Street Hospital
    Full Title: A paediatric phase I/II study of intermittent dosing of the MEK-1 inhibitor selumetinib in children with neurofibromatosis type-1 and inoperable plexiform neurofibroma and/or progressive optic path...
    Medical condition: Neurofibromatosis type 1 associated plexiform neurofibromas Neurofibromatosis type 1 associated progressive or relapsed optic pathway glioma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10029270 Neurofibromatosis, type 1 (von Recklinghausen's disease) LLT
    20.0 100000004864 10065866 Plexiform neurofibroma LLT
    20.0 100000004864 10030935 Optic nerve glioma LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-000899-15 Sponsor Protocol Number: EORTC-1531-ROG Start Date*: 2019-12-03
    Sponsor Name:European Organisation for Research and Treatment of Cancer (EORTC)
    Full Title: Radiotherapy and 6-month androgen deprivation therapy with or without apalutamide in Intermediate and Limited High Risk Localized Prostate Cancer: a phase III study
    Medical condition: Intermediate and Limited High Risk Localized Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Prematurely Ended) ES (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-002106-13 Sponsor Protocol Number: ATH3G10-005 Start Date*: 2017-09-06
    Sponsor Name:Athera Biotechnologies AB
    Full Title: Double-blind, randomised, placebo-controlled, multicentre, Phase IIa study to investigate the effect of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together ...
    Medical condition: Arterial inflammation in subjects with elevated lipoprotein a (Lp[a])
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000022953 10051615 Atherosclerotic cardiovascular disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-000344-21 Sponsor Protocol Number: MP1032-CT05 Start Date*: 2021-06-24
    Sponsor Name:MetrioPharm AG
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PROOF-OF-CONCEPT, PHASE IIA STUDY OF MP1032 PLUS STANDARD OF CARE VS STANDARD OF CARE IN THE TREATMENT OF HOSPITALIZED PATIENTS WITH MOD...
    Medical condition: Moderate to severe coronavirus disease 2019 (COVID 19)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004862 10084401 COVID-19 respiratory infection LLT
    23.1 10042613 - Surgical and medical procedures 10084460 COVID-19 treatment PT
    23.0 100000004862 10084382 Coronavirus disease 2019 LLT
    23.1 100000004862 10084529 2019 novel coronavirus infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) BG (Completed) IT (Ongoing) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2011-005335-97 Sponsor Protocol Number: GO25632 Start Date*: 2012-10-11
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of bevacizumab, and associated biomarkers, in combination with paclitaxel compared w...
    Medical condition: HER2-negative metastatic breast cancer.
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Prematurely Ended) GB (Prematurely Ended) IT (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    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.
    1  2  3  4  5  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun May 19 19:28:43 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA