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Clinical trials for Short Term Exposure Limit

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 ).  
     
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    13 result(s) found for: Short Term Exposure Limit. Displaying page 1 of 1.
    EudraCT Number: 2020-002541-41 Sponsor Protocol Number: 02679 Start Date*: 2021-04-23
    Sponsor Name:Universitätsmedizin Göttingen
    Full Title: A phase II trial of Cabozantinib in patients with advanced, low proliferative NEN G3.
    Medical condition: We will include patients with NET G3 and upto four prior antitumoral treatment lines and NEC Ki67 low after failure of standard treatment with conventional chemotherapy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000459-41 Sponsor Protocol Number: PSMA-617-01 Start Date*: 2018-09-04
    Sponsor Name:Endocyte, Inc., A Novartis Company
    Full Title: VISION: An international, prospective, open label, multicenter, randomized Phase 3 study of 177LU-PSMA-617 in the treatment of patients with progressive PSMA-positive metastatic castration-resistan...
    Medical condition: PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) SE (Completed) FR (Completed) DK (Completed) NL (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005186-13 Sponsor Protocol Number: CLNP023F12301 Start Date*: 2021-08-26
    Sponsor Name:Novartis Pharma AG
    Full Title: A multicenter, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult aHUS patients who are naive to complement inhibitor therapy
    Medical condition: atypical hemolytic uremic syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 10005329 - Blood and lymphatic system disorders 10079841 Atypical hemolytic uremic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing) SI (Ongoing) CZ (Ongoing) SK (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-001712-61 Sponsor Protocol Number: NN5401-3940 Start Date*: 2011-10-28
    Sponsor Name:Novo Nordisk A/S
    Full Title: A 26-week, randomised, open-label, multinational, treat-to-target trial comparing efficacy and safety of insulin degludec/insulin aspart (IDegAsp) twice daily (BID) and BIAsp 30 BID both with metfo...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BG (Completed) PL (Completed) CZ (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2011-004436-61 Sponsor Protocol Number: BRF113771 Start Date*: 2012-03-30
    Sponsor Name:GlaxoSmithKline Research and Development Limited
    Full Title: A Four-Part, Open-Label Study to Evaluate the Effects of Repeat Dose GSK2118436 on the Single Dose Pharmacokinetics of Warfarin, the Effects of Repeat Dose Oral Ketoconazole and Oral Gemfibrozil on...
    Medical condition: Skin Cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 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 (Completed)
    Trial results: View results
    EudraCT Number: 2014-005325-12 Sponsor Protocol Number: CFZ014 Start Date*: 2015-08-10
    Sponsor Name:Onyx Therapeutics, Inc.
    Full Title: A Randomized, Open-label, Phase 3 Study in Subjects with Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination with Dexamethasone, Comparing Once-weekly versus Twice-weekly ...
    Medical condition: Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed) HU (Completed) BE (Completed) DK (Completed) ES (Completed) PL (Completed) GR (Completed) SE (Completed) FI (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2012-004786-40 Sponsor Protocol Number: PB-102-F01 Start Date*: 2013-05-10
    Sponsor Name:Protalix Ltd.
    Full Title: A Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks ...
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-002696-40 Sponsor Protocol Number: ACH171-002 Start Date*: 2006-10-12
    Sponsor Name:Achillion Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Multiple Doses of ACH-0137171 in Subjects w...
    Medical condition: Chronic Hepatitis C Infection
    Disease: Version SOC Term Classification Code Term Level
    8.1 10008912 Chronic hepatitis C LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-003654-86 Sponsor Protocol Number: GLPG0634-CL-204 Start Date*: 2013-08-15
    Sponsor Name:Galapagos NV
    Full Title: Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoi...
    Medical condition: moderately to severely active rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) AT (Completed) ES (Completed) LV (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-003635-31 Sponsor Protocol Number: GLPG0634-CL-203 Start Date*: 2013-06-26
    Sponsor Name:Galapagos NV
    Full Title: Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severel...
    Medical condition: moderately to severely active rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) DE (Completed) CZ (Completed) ES (Completed) AT (Completed) LV (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-002057-38 Sponsor Protocol Number: 64091742PCR2001 Start Date*: 2016-09-26
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
    Medical condition: mCRPC and DNA-repair anomalies
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) BE (Completed) DK (Prematurely Ended) NL (Completed) FR (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-000558-37 Sponsor Protocol Number: ARQ092-103 Start Date*: 2017-02-22
    Sponsor Name:ArQule, Inc.
    Full Title: A Phase 1/2 Study of ARQ 092 in Patients with Overgrowth Diseases and Vascular Anomalies with Genetic Alterations of the PI3K/AKT Pathway
    Medical condition: subjects (at least 6 years) suffering from diseases overgrowth and vascular anomalies with genetic alterations of the PI3K / AKT pathway.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing) FR (Ongoing) ES (Temporarily Halted) GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-005529-11 Sponsor Protocol Number: UX023-CL303 Start Date*: 2016-02-01
    Sponsor Name:Ultragenyx Pharmaceutical Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study with Open-Label Extension to Assess the Efficacy and Safety of KRN23 in Adults with X-linked Hypophosphatemia (XLH)
    Medical condition: XLH is a disorder of hypophosphatemia, renal phosphate wasting, and the most common inheritable form of rickets. In XLH patients, excess circulating fibroblast growth factor (FGF23) impair phospha...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10016206 Familial hypophosphataemic rickets LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) FR (Completed) DK (Completed) IT (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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