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Clinical trials for Safety factors

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    1,503 result(s) found for: Safety factors. Displaying page 1 of 76.
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    EudraCT Number: 2018-004686-13 Sponsor Protocol Number: LAS-212 Start Date*: 2020-05-01
    Sponsor Name:Octapharma Pharmazeutika Produktionsges.m.b.H.
    Full Title: An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement o...
    Medical condition: Replacement of multiple coagulation factors in pediatric patients with acquired deficiencies due to liver disease and/or in pediatric patients requiring cardiac surgery or liver transplantation
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-002740-85 Sponsor Protocol Number: BTI-01D-EC/12/ALO Start Date*: 2014-02-11
    Sponsor Name:BTI BIOTECHNOLOGY INSTITUTE IMASD
    Full Title: A Pilot Randomized, Double-blind, Placebo-controlled Clinical Trial to Obtain Preliminary Data on Efficacy and Safety in the Application of PRGF-Endoret by Mesotherapy, in the Treatment of Male and...
    Medical condition: Androgenetic alopecia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-004625-96 Sponsor Protocol Number: Protocol date 15. 9. 2004 Start Date*: 2005-10-21
    Sponsor Name:Group for the Study of Resistant Depression (GSRD), Head: Prof. Julien Mendlewicz
    Full Title: A naturalistic study of the efficacy and safety of escitalopram in treatment resistant depression.
    Medical condition: The screening assessment consists of a consecutive recruitment of depressed pat. adequately treated for their current depressive episode. 2. Pat. who failed to respond to a well-conducted treatment...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003617-33 Sponsor Protocol Number: 03-2005 Start Date*: Information not available in EudraCT
    Sponsor Name:Charité
    Full Title: A Randomised Cross-Over Study to Explore the Pathophysiological Mechanisms Involved in the Treatment of Actinic Keratoses with Solaraze
    Medical condition: actinic keratosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-002644-32 Sponsor Protocol Number: EFC14875 Start Date*: 2017-11-14
    Sponsor Name:SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    Full Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes, Ca...
    Medical condition: Type 2 diabetes mellitus Chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    20.0 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) LV (Completed) GB (Completed) HU (Completed) SE (Completed) NO (Completed) FR (Completed) NL (Completed) DK (Completed) ES (Prematurely Ended) LT (Completed) EE (Completed) PT (Completed) BE (Completed) GR (Completed) BG (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2018-004400-19 Sponsor Protocol Number: 1707-FIVI-084-MV Start Date*: 2019-05-30
    Sponsor Name:IVIRMA MADRID
    Full Title: Study of the effects of telomerase reactivation with Danazol on ovarian function. A Pilot Study.
    Medical condition: low ovarian reserve
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004872 10036602 Premature ovarian failure LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-001624-17 Sponsor Protocol Number: 210321 Start Date*: 2021-07-21
    Sponsor Name:Karolinska University Hospital
    Full Title: Safety of oral micronized progesterone versus norethisterone acetate in continuous combination with oral estrogen as menopausal hormone therapy – a double-blind randomized study- PROBES study (Prog...
    Medical condition: Climacteric symptoms
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001209-34 Sponsor Protocol Number: PRGFFC17 Start Date*: 2018-05-28
    Sponsor Name:FISEVI
    Full Title: Phase III CLINICAL TRIAL, MULCHNTRIC, RANDOMIZED, BLIND DOUBLE IN TWO PARALLEL GROUPS TO COMPARE THE EFFECTIVENESS AND SAFETY OF THE SIMPLE CLOSURE OF THE CRYPTTOGLANDULAR ANAL FISTULA WITH OR WITH...
    Medical condition: Patients with anal fistula
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000623-27 Sponsor Protocol Number: EC_01_2017 Start Date*: 2017-09-11
    Sponsor Name:Fundacion para la investigacion biomedica HUPA
    Full Title: Role of autologous biological therapy in knee osteoarthritis. Intraosseous application of plasma rich in growth factors , improve of functional capacity and pain, compared to intraarticular applic...
    Medical condition: Knee osteoarthritis.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10031161 Osteoarthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-000382-19 Sponsor Protocol Number: BE1116_3001 Start Date*: 2005-09-15
    Sponsor Name:ZLB Behring GmbH
    Full Title: Efficacy and tolerance of BERIPLEX® P/N in subjects with acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation
    Medical condition: Acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation requiring an immediate reversal of anticoagulant effect (i.e. emergency surgery or acute bleeding).
    Disease: Version SOC Term Classification Code Term Level
    7.1 10000534 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) HU (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004755-21 Sponsor Protocol Number: CHUBX2012/17 Start Date*: 2016-03-15
    Sponsor Name:CHU de Bordeaux
    Full Title: Multicenter double-blind randomized clinical trial assessing efficacy and safety of exenatide in the treatment of hypothalamic obesity after craniopharyngioma therapy.
    Medical condition: Hypothalamic obesity after craniopharyngioma therapy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-004555-30 Sponsor Protocol Number: 1903-004 Start Date*: 2009-04-28
    Sponsor Name:Merck Sharp & Dohme (Sweden) AB
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Lipid-Modifying Effect and Tolerability of MK-1903 in Patients with Dyslipidemia
    Medical condition: Dyslipidemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058110 Dyslipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2014-002833-70 Sponsor Protocol Number: s56892 Start Date*: 2014-12-18
    Sponsor Name:UZLeuven
    Full Title: Radium-223 in patients with PSA progression and without clinical metastases following maximal local therapy: a pilot study
    Medical condition: Patients with prostate cancer (PCa) who experience PSA progression and who are without detectable metastases following maximal local treatment consisting of radical prostatectomy (RP) + pelvic l...
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003982-32 Sponsor Protocol Number: UCA-01-EC/13/ART Start Date*: 2013-12-26
    Sponsor Name:Arthroscopic Surgery Unit
    Full Title: Pilot study to evaluate combination of intraosseous with intra-articular infiltrations of plasma rich in growth factors (PRGF®-Endoret®) in the treatment of knee osteoarthritis.
    Medical condition: Knee osteoarthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-004100-35 Sponsor Protocol Number: FSJD-PIOSPIMET-2012 Start Date*: 2012-12-20
    Sponsor Name:Fundació per la Recerca i la Docència Sant Joan de Déu
    Full Title: A prospective, open-label, randomized, two-armed clinical trial to evaluate the efficacy and safety of a combination of ethinyl-estradiol and levonorgestrel versus a low-dose combination of pioglit...
    Medical condition: Ovarian hyperandrogenism
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-000356-17 Sponsor Protocol Number: 2 79 58035 700 Start Date*: Information not available in EudraCT
    Sponsor Name:Beaufour Ipsen Pharma
    Full Title: PHASE IIIB, INTERNATIONAL, SINGLE GROUP, OPEN STUDY TO DEFINE AN OPTIMAL MONITORING OF IGF-I IN CHILDREN TREATED WITH NUTROPINAQ USING A NOVEL CAPILLARY BLOOD COLLECTION METHOD
    Medical condition: growth failure associated with: - inadequate growth hormone secretion - Turner syndrome, confirmed by karyotype - chronic renal insufficiency up to renal transplantation
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Completed) DK (Completed) AT (Completed) SE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2018-003042-16 Sponsor Protocol Number: IIBSP-PTE-2018-35 Start Date*: 2019-02-08
    Sponsor Name:Institut de Recerca H. de la Santa Creu i Sant Pau
    Full Title: Randomized clinical trial to evaluate the efficacy of fibrin membrane graft with eye drops concentrated in autologous growth factors in primary pterygium surgery comparing it with amniotic membrane...
    Medical condition: Pterigyum
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-000167-25 Sponsor Protocol Number: UC-0110/1201 Start Date*: 2012-05-29
    Sponsor Name:UNICANCER
    Full Title: A multicentric randomized phase II study evaluating dual targeting of the EGFR using the combination of cetuximab and afatinib versus cetuximab alone in patients with chemotherapy refractory wtKRAS...
    Medical condition: Refractory wtKRAS metastatic colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-005094-28 Sponsor Protocol Number: VAC3_COVID-19_antibody_study_V1 Start Date*: 2021-10-21
    Sponsor Name:Medical University of Vienna, Department for Internal Medicine III, Division of Rheumatology
    Full Title: Population-based prospective, clinical study on efficacy and safety of a booster COVID-19 vaccination
    Medical condition: SARS-CoV-2 infection prevention
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2007-007862-39 Sponsor Protocol Number: BE1116_3003 Start Date*: 2009-01-16
    Sponsor Name:CSL Behring GmbH
    Full Title: An open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of BERIPLEX® P/N compared with plasma for rapid reversal of coagulopathy induced by vitamin K an...
    Medical condition: Perioperative prophylaxis for emergency surgery in subjects who have an acquired deficiency of vitamin K-dependent coagulation factors and proteins C and S
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10065667 Haemorrhage prophylaxis PT
    14.1 100000004848 10009789 Coagulation factors decreased LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) PL (Prematurely Ended) IT (Prematurely Ended)
    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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