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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   44394   clinical trials with a EudraCT protocol, of which   7406   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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    28,014 result(s) found for: SAFETY. Displaying page 534 of 1,401.
    EudraCT Number: 2014-002111-41 Sponsor Protocol Number: AI438-047 Start Date*: 2015-05-06
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Multi-arm Phase 3 Randomized Placebo Controlled Double Blind Clinical Trial to Investigate the Efficacy and Safety of BMS-663068 in Heavily Treatment Experienced Subjects Infected with Multi-drug...
    Medical condition: HIV, Adult
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Completed) BE (Completed) NL (Ongoing) GB (Completed) NO (Prematurely Ended) IE (Completed) PT (Completed) GR (Completed) FR (Completed) RO (Trial now transitioned) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002674-26 Sponsor Protocol Number: M20-259 Start Date*: 2020-10-29
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have fail...
    Medical condition: Crohns Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) SE (Completed) BE (Trial now transitioned) DE (Trial now transitioned) AT (Trial now transitioned) CZ (Trial now transitioned) HU (Trial now transitioned) SK (Trial now transitioned) FR (Trial now transitioned) GB (GB - no longer in EU/EEA) BG (Trial now transitioned) GR (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-005774-25 Sponsor Protocol Number: SC104 Start Date*: 2024-09-06
    Sponsor Name:SOTIO Biotech AG
    Full Title: A phase 2, open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate the efficacy and safety in patients with selected advanced/refractory solid tumors
    Medical condition: advanced/refractory solid tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10029514 Non-small cell lung cancer NOS LLT
    21.0 100000004864 10052362 Metastatic colorectal cancer LLT
    24.1 100000004864 10085908 Cutaneous squamous cell carcinoma LLT
    21.0 100000004864 10019829 Hepatocellular carcinoma recurrent LLT
    21.1 100000004864 10076506 Castration-resistant prostate cancer LLT
    20.0 100000004864 10033130 Ovarian cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Temporarily Halted) CZ (Prematurely Ended) BE (Completed) IT (Prematurely Ended) HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-003741-15 Sponsor Protocol Number: MSC_apceth_101/1 Start Date*: 2013-06-27
    Sponsor Name:apceth GmbH & Co. KG
    Full Title: Treatment of Advanced Gastrointestinal Cancer in a Phase I/II trial with modified autologous MSC_apceth_101. Open-label, multicentre, phase I/II.
    Medical condition: Patients suffering from advanced, recurrent or metastatic gastrointestinal adenocarcinoma.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017991 Gastrointestinal neoplasms malignant and unspecified HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003937-62 Sponsor Protocol Number: CLR_16_23 Start Date*: 2017-03-20
    Sponsor Name:SUN Pharma Global FZE
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects with Active Psoriatic Arthritis
    Medical condition: Psoriatic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000018188 10037160 Psoriatic arthritis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-000611-17 Sponsor Protocol Number: LTS12745 Start Date*: 2017-08-28
    Sponsor Name:Alfresa Pharma Corporation and Sanofi KK
    Full Title: A Long term study of M071754 - A open-label study in patients with infantile spasms.
    Medical condition: Patients diagnosed with infantile spasms
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10021750 Infantile spasms PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000502-11 Sponsor Protocol Number: EKOS-12 Start Date*: 2016-07-21
    Sponsor Name:EKOS Corporation
    Full Title: Study of the Optimum Duration of Acoustic Pulse Thrombolysis (APT) Procedure in the Treatment of Acute Submassive Pulmonary Embolism (OPTALYSE PE).
    Medical condition: Submassive pulmonary embolism
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2012-002993-29 Sponsor Protocol Number: M13-625 Start Date*: 2015-07-15
    Sponsor Name:Abbott Laboratories GmbH
    Full Title: A Randomized, Open-label, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg daily versus Crinone 8% intravaginal progesterone gel 90 mg daily ...
    Medical condition: Treatment for the luteal support in in-vitro fertilization (IVF).
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004865 10021572 In vitro fertilization LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-005019-34 Sponsor Protocol Number: CTMT212X2106 Start Date*: 2016-05-24
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase I/II study of safety and efficacy of ribociclib (LEE011) in combination with trametinib (TMT212) in patients with metastatic or advanced solid tumors
    Medical condition: Solid tumors, Pancreatic Cancer, Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10049280 Solid tumour LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033604 Pancreatic cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-005023-92 Sponsor Protocol Number: 4658-203 Start Date*: 2017-03-28
    Sponsor Name:Sarepta Therapeutics, Inc.
    Full Title: An Open-Label, Multi-Center Study to Evaluate the Safety, Efficacy and Tolerability of Eteplirsen in Early Stage Duchenne Muscular Dystrophy
    Medical condition: Patients with Duchenne Muscular Dystropy Amenable to Exon 51 Skipping
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-000019-26 Sponsor Protocol Number: D5670C00013 Start Date*: 2018-05-04
    Sponsor Name:MedImmune Limited, a wholly owned subsidiary of AstraZeneca
    Full Title: A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Subjects with Type 2 Diabetes Mellitus and Renal Impairment
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-000596-27 Sponsor Protocol Number: VAC52150EBL2001 Start Date*: 2015-05-18
    Sponsor Name:Janssen Vaccines & Prevention BV
    Full Title: A Randomized, Observer-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Prime-Boost Regimens of the Candidate Prophylactic Vaccines for Ebol...
    Medical condition: Ebola
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10014071 Ebola disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-002252-27 Sponsor Protocol Number: TED-C14-006 Start Date*: 2016-09-19
    Sponsor Name:NPS Pharmaceuticals, Inc.
    Full Title: A 24-Week Double-blind, Safety, Efficacy, and Pharmacodynamic Study Investigating Two Doses of Teduglutide in Pediatric Subjects Through 17 Years of Age with Short Bowel Syndrome who are Dependent ...
    Medical condition: Short Bowel Syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) FI (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003147-35 Sponsor Protocol Number: M14-567 Start Date*: 2014-12-16
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (R...
    Medical condition: Chronic Hepatitis C Virus (HCV) Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-004888-37 Sponsor Protocol Number: FFR111158 Start Date*: 2016-08-03
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A Pilot, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of Once-daily Intranasal Administration of Fluticasone Furoate Nasal Spr...
    Medical condition: Irritant (non-allergic) rhinitis
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002154-36 Sponsor Protocol Number: CIGE025F1301 Start Date*: 2019-02-13
    Sponsor Name:Novartis Pharma KK
    Full Title: A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Adult and Adolescent Patients With Inadequately Controlled...
    Medical condition: Severe Japanese cedar pollinosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10036020 Pollinosis LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038738 Respiratory, thoracic and mediastinal disorders SOC
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005064-42 Sponsor Protocol Number: AF219-012 Start Date*: 2016-02-26
    Sponsor Name:Afferent Pharmaceuticals, Inc.
    Full Title: A 12-Week Study to Assess the Efficacy and Safety of AF-219 in Subjects with Treatment Refractory Chronic Cough
    Medical condition: Chronic Cough
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-004753-33 Sponsor Protocol Number: CSLCT-QIV-15-03 Start Date*: 2016-12-15
    Sponsor Name:Seqirus GmbH
    Full Title: A Phase 3, Randomized, Multicenter, Observer-blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) with a US-li...
    Medical condition: Prophylaxis for influenza virus infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000592-24 Sponsor Protocol Number: MR308-3501 Start Date*: 2017-03-15
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A Randomized, Double-Blind, Multicenter, Placebo- and active Comparator-Controlled Study to evaluate Efficacy and Safety of MR308 in the Treatment of Acute Pain After Third Molar Tooth Extraction (...
    Medical condition: Acute pain after third molar tooth extraction; dental procedure must have involved extraction of at least two impacted third molars requireing bone removal. If only two impacted third molars are ex...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000023314 10066714 Acute pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-003962-24 Sponsor Protocol Number: 6632-9050-04 Start Date*: 2016-12-27
    Sponsor Name:Medice Arzneimittel Pütter GmbH & Co. KG
    Full Title: A multi-centre, randomized, placebo-controlled, double-blind, parallel-group study investigating safety and efficacy of a sore throat lozenge in the symptomatic treatment of patients with acute pha...
    Medical condition: Acute Pharyngitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
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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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