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Clinical trials for 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   44380   clinical trials with a EudraCT protocol, of which   7392   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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    27,999 result(s) found for: SAFETY. Displaying page 396 of 1,400.
    «« First « Previous 392  393  394  395  396  397  398  399  400  Next» Last»»
    EudraCT Number: 2010-018485-24 Sponsor Protocol Number: 979 Start Date*: 2010-10-20
    Sponsor Name:Biotest AG
    Full Title: A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and...
    Medical condition: Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) DE (Completed) HU (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2016-003653-15 Sponsor Protocol Number: AC-055G202 Start Date*: 2017-09-12
    Sponsor Name:ACTELION Pharmaceuticals Ltd
    Full Title: A multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascu...
    Medical condition: Heart failure with preserved ejection fraction and pulmonary vascular disease
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004849 10076396 Heart failure with preserved ejection fraction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) GB (GB - no longer in EU/EEA) DK (Completed) CZ (Completed) AT (Completed) SE (Completed) ES (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2017-000980-33 Sponsor Protocol Number: 42847922ISM2005 Start Date*: 2018-06-11
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Active- and Placebo-Controlled Polysomnography Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Subjects with Ins...
    Medical condition: Insomnia Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10078083 Insomnia disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-004020-65 Sponsor Protocol Number: MK-8259-038 Start Date*: 2017-07-20
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase-IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of Golimumab (MK-8259 [SCH 900259]) After Treatment Withdrawal, Compared With Cont...
    Medical condition: Treatment of non-radiographic axial spondyloarthritis (nr-axSpA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10076297 Non-radiographic axial spondyloarthritis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) ES (Completed) NL (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2004-002571-16 Sponsor Protocol Number: MBP8298-01 Amendment 04 Start Date*: 2007-06-29
    Sponsor Name:BioMS Technology Corp
    Full Title: A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis.
    Medical condition: Secondary progressive multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10063400 Secondary progressive multiple sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) FI (Completed) DK (Completed) ES (Completed) EE (Completed) NL (Completed) LT (Prematurely Ended) LV (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002867-41 Sponsor Protocol Number: OPS-C-001/D-FR-01072-001 Start Date*: 2015-12-10
    Sponsor Name:Ipsen Pharma
    Full Title: An international multi-center, open-label study to evaluate safety, tolerability, biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201 for the therapy of somatostatin receptor positi...
    Medical condition: Neuroendocrine tumors (NETs)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052399 Neuroendocrine tumour PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) GB (GB - no longer in EU/EEA) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002841-12 Sponsor Protocol Number: C3591025 Start Date*: 2019-12-16
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 1, Open-Label, Single-Dose Study To Assess The Pharmacokinetics, Safety And Tolerability Of Ceftazidime-Avibactam (Caz-Avi) In Children From 3 Months To Less Than 18 Years Of Age Who Are Ho...
    Medical condition: Suspected Or Confirmed Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004862 10052596 Nosocomial pneumonia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SK (Prematurely Ended) GB (GB - no longer in EU/EEA) EE (Prematurely Ended) GR (Prematurely Ended) NL (Ongoing) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003413-25 Sponsor Protocol Number: GCT1015-04 Start Date*: 2018-03-07
    Sponsor Name:Genmab A/S
    Full Title: A single arm, multicenter, international trial of tisotumab vedotin (HuMax®-TF-ADC) in previously treated, recurrent or metastatic cervical cancer
    Medical condition: recurrent or metastatic cervical cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008342 Cervix carcinoma PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: CZ (Completed) DK (Completed) BE (Completed) DE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-000111-41 Sponsor Protocol Number: M14-748 Start Date*: 2016-04-01
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without ...
    Medical condition: Chronic Hepatitis C infection
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) BE (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003253-24 Sponsor Protocol Number: 402-C-1803 Start Date*: 2020-03-04
    Sponsor Name:Reata Pharmaceuticals, Inc.
    Full Title: An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease
    Medical condition: Chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) FR (Completed) BE (Completed) DE (Prematurely Ended) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2019-003653-29 Sponsor Protocol Number: BT5528-100 Start Date*: 2020-10-09
    Sponsor Name:Bicycle Tx Limited
    Full Title: Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients with Advanced Malignancies Associated with EphA2 Expression
    Medical condition: Advanced Malignancies Associated with EphA2 Expression
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-001773-17 Sponsor Protocol Number: FGCL-4592-082 Start Date*: 2017-11-06
    Sponsor Name:FibroGen, Inc.
    Full Title: A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients with Lower Risk Myelodysplastic Syndrome...
    Medical condition: Anemia due to Myelodysplastic Syndrome (MDS) in International Prognostic Scoring System – Revised Very Low, Low, or Intermediate Risk with <5% Blasts, and has low red blood cell transfusion burden ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) ES (Ongoing) GB (GB - no longer in EU/EEA) BE (Completed) DK (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004566-28 Sponsor Protocol Number: MK-3475-224 Start Date*: 2016-06-14
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 2 Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects with Advanced Hepatocellular Carcinoma (KEYNOTE-224)
    Medical condition: Hepatocellular Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10019828 Hepatocellular carcinoma non-resectable LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-004198-38 Sponsor Protocol Number: KPL-716-C201 Start Date*: Information not available in EudraCT
    Sponsor Name:Kiniksa Pharmaceuticals, Ltd.
    Full Title: KPL-716-C201: A Phase 2a/b, Randomized, Double-Blind, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects wit...
    Medical condition: Pruritus in Subjects with Prurigo Nodularis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10037084 Prurigo nodularis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) FR (Completed) BE (Completed) IT (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003623-65 Sponsor Protocol Number: 1311.30 Start Date*: 2016-05-17
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: BI 655066/ABBV-066 (risankizumab) versus adalimumab in a randomized, double blind, parallel group trial in moderate to severe plaque psoriasis to assess safety and efficacy after 16 weeks of treatm...
    Medical condition: psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) FI (Completed) PT (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-002475-35 Sponsor Protocol Number: BO42353 Start Date*: 2021-06-08
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYND...
    Medical condition: Atypical Hemolytic Uremic Syndrome (aHUS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004851 10079841 Atypical hemolytic uremic syndrome LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000464-27 Sponsor Protocol Number: ART27.13-100 Start Date*: 2020-10-29
    Sponsor Name:Artelo Biosciences Limited
    Full Title: A Phase 1/2 Trial of the Synthetic Cannabinoid ART27.13 in Patients with Cancer Anorexia and Weight Loss
    Medical condition: Cancer anorexia and weight loss
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10002646 Anorexia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Trial now transitioned) NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001733-12 Sponsor Protocol Number: MO41787 Start Date*: 2021-04-15
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE IIIb, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SUBCUTANEOUS EMICIZUMAB IN PATIENTS FROM BIRTH TO 12 MONTHS OF AG...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Ongoing) AT (Trial now transitioned) FR (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004839-23 Sponsor Protocol Number: CA-4948-102 Start Date*: 2023-02-09
    Sponsor Name:Curis, Inc
    Full Title: A Phase 1/2a, Open-Label Dose Escalation and Cohort Expansion Study of Orally Administered CA-4948(IRAK4i) as a Monotherapy in patients with Acute Myelogenous Leukemia or Myelodysplastic Syndrome a...
    Medical condition: Acute Myelogenous Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10001941 AML LLT
    20.0 100000004864 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) PL (Completed) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000648-32 Sponsor Protocol Number: SCY-078-302 Start Date*: 2023-03-31
    Sponsor Name:SCYNEXIS, Inc.
    Full Title: A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin followed by Oral Ibrexafungerp ver...
    Medical condition: Invasive Candidiasis/ Candidemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10060573 Candidemia LLT
    20.0 10021881 - Infections and infestations 10064954 Invasive candidiasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) FR (Trial now transitioned) ES (Temporarily Halted) BE (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
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    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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