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Clinical trials for Surrogate endpoints

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    116 result(s) found for: Surrogate endpoints. Displaying page 1 of 6.
    1  2  3  4  5  6  Next»
    EudraCT Number: 2007-003627-20 Sponsor Protocol Number: NAI008/I Start Date*: 2009-01-28
    Sponsor Name:University of Dundee, Research & Innovation Services
    Full Title: Comparative Relative Lung Bioavailability of HFA-Seretide via spacer devices in healthy volunteers
    Medical condition: Bronchial Asthma
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-003426-32 Sponsor Protocol Number: DCOne-002 Start Date*: 2017-12-11
    Sponsor Name:DCprime bv
    Full Title: AN INTERNATIONAL, MULTICENTRE, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWO DIFFERENT VACCINATION REGIMENS OF IMMUNOTHERAPY WITH ALLOGENEIC DENDRITIC CELLS, DCP-001, IN PATIENTS WIT...
    Medical condition: The medical condition investigated are patients with acute myeloid leukemia in complete remission with persistent minimal residual disease and as such are at high risk of relapse.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) NO (Completed) SE (Completed) FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-015397-35 Sponsor Protocol Number: KF5503/53 Start Date*: 2010-02-12
    Sponsor Name:Grünenthal GmbH
    Full Title: A multicenter, open-label trial to assess cognitive and psychomotor performance as surrogate parameters for driving ability under stable long term treatment with tapentadol hydrochloride prolonged-...
    Medical condition: Pain
    Disease: Version SOC Term Classification Code Term Level
    14.0 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-005252-14 Sponsor Protocol Number: KAI-9803-001 Start Date*: 2005-04-21
    Sponsor Name:KAI Pharmaceuticals Incorporated
    Full Title: Direct Inhibition of δ Protein Kinase C Enzyme to Limit Total Infarct Size in Acute Myocardial Infarction (DELTA MI): Intracoronary KAI-9803 for Injection as an Adjunct to Primary Percutaneous Coro...
    Medical condition: Acute myocardial infarction with ST elevation
    Disease: Version SOC Term Classification Code Term Level
    7.1 10000891 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) CZ (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-005385-38 Sponsor Protocol Number: GFT505-315-1 Start Date*: 2016-03-04
    Sponsor Name:Genfit SA
    Full Title: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Non-Alcoholic Steatohepatitis (NASH) and fibrosis.
    Medical condition: Non-Alcoholic Steatohepatitis (NASH) and fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10018065 - General disorders and administration site conditions 10016642 Fibrosis PT
    22.0 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) GB (Completed) DE (Completed) CZ (Prematurely Ended) SE (Completed) IT (Prematurely Ended) PT (Completed) NL (Completed) DK (Prematurely Ended) FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-000545-40 Sponsor Protocol Number: FELZ01 Start Date*: 2021-08-01
    Sponsor Name:Medical University of Vienna
    Full Title: Safety, Tolerability and Efficacy of Monoclonal CD38 Antibody Felzartamab in Late Antibody-Mediated Renal Allograft Rejection – A Phase 2 Pilot Trial
    Medical condition: Late active or chronic active antibody-mediated rejection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-012338-56 Sponsor Protocol Number: VAS203/II/1/03 Start Date*: 2009-07-10
    Sponsor Name:vasopharm GmbH
    Full Title: AN EXPLORATIVE PHASE IIa STUDY TO ASSESS SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF VAS203 IN PATIENTS WITH MODERATE AND SEVERE TRAUMATIC BRAIN INJURY
    Medical condition: Moderate and severe traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060690 Traumatic brain injury LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed) ES (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001172-15 Sponsor Protocol Number: APN01-01-COVID19 Start Date*: 2020-04-08
    Sponsor Name:APEIRON Biologics AG
    Full Title: Recombinant human angiotensin-converting enzyme 2 (rhACE2) as a treat-ment for patients with COVID-19
    Medical condition: Severe COVID-19 POSITIVE hospitalized male or female, between 18 and ≤ 80 years of age
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) DK (Completed) AT (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2006-002857-54 Sponsor Protocol Number: TMAE-104 Start Date*: 2006-11-10
    Sponsor Name:Octapharma AG
    Full Title: International clinical study to investigate the efficacy and safety of Wiloctin in patients with inherited von willebrand disease (vWD)
    Medical condition: von Willebrand Jürgends syndrom in children under 6 years of age
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-001735-49 Sponsor Protocol Number: CTU/2015/174 Start Date*: 2019-07-01
    Sponsor Name:University College London
    Full Title: Rivaroxaban versus warfarin for stroke patients with antiphospholipid syndrome, with or without SLE (RISAPS): a randomised, controlled, open-label, phase II/III, non-inferiority trial
    Medical condition: Patients with stroke or other ischaemic brain injury who have antiphospholipid syndrome (APS), with or without systemic lupus erythematosus (SLE)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10002817 Antiphospholipid syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2008-005544-17 Sponsor Protocol Number: EMR 200038-010 Start Date*: 2009-08-20
    Sponsor Name:Merck KGaA
    Full Title: A randomized, double-blind, controlled phase III study of Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in combination with hormonal treatment versus hormonal treatment alone for first-line therapy...
    Medical condition: post-menopausal women with estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally advanced, recurrent, or metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    9.1 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: CZ (Prematurely Ended) SE (Prematurely Ended) BE (Completed) DE (Prematurely Ended) HU (Completed) NL (Completed) IE (Prematurely Ended) AT (Prematurely Ended) PT (Prematurely Ended) FR (Completed) IT (Prematurely Ended) SK (Prematurely Ended) GR (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-005115-16 Sponsor Protocol Number: FORMA-04 Start Date*: 2020-04-22
    Sponsor Name:Octapharma AG
    Full Title: Prospective, open-label, uncontrolled, Phase III study to assess the efficacy, safety, and pharmacokinetics of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during an...
    Medical condition: Congenital fibrinogendeficiency
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-002287-33 Sponsor Protocol Number: 07009GM-A Start Date*: 2008-10-28
    Sponsor Name:Belfast Health and Social Care Trust [...]
    1. Belfast Health and Social Care Trust
    2. Queens University Belfast
    Full Title: Effect of HMG-Co A reductase inhibition on endothelial dysfunction, bioavailability of tetrahydrobiopterin (BH4) and functional regulation of endothelial nitric oxide synthase (eNOS) in human heart...
    Medical condition: Heart failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-001438-34 Sponsor Protocol Number: 20-101 Start Date*: 2005-05-23
    Sponsor Name:McNeil Consumer and Specialty Pharmaceuticals
    Full Title: A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and...
    Medical condition: Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-005141-23 Sponsor Protocol Number: 021FSGS16010 Start Date*: 2018-09-18
    Sponsor Name:Retrophin, Inc.
    Full Title: A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with...
    Medical condition: Focal segmental glomerulosclerosis (FSGS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10067757 Focal segmental glomerulosclerosis PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) CZ (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) HU (Prematurely Ended) DK (Trial now transitioned) EE (Trial now transitioned) SE (Trial now transitioned) PT (Trial now transitioned) BE (Trial now transitioned) HR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004319-29 Sponsor Protocol Number: P170914J Start Date*: 2021-10-04
    Sponsor Name:ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (AP-HP)
    Full Title: " LEVOSIMENDAN to facilitate weaning from ECMO in severe cardiogenic shock patients
    Medical condition: Adult patients with acute cardiogenic shock refractory to conventional therapy placed on VA-ECMO support and for whom withdrawal from ECMO is possible.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10007625 Cardiogenic shock PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-000830-11 Sponsor Protocol Number: RL05/7239 Start Date*: 2006-07-26
    Sponsor Name:Leeds Teaching Hospitals NHS Trust
    Full Title: A randomised prospective trial of tacrolimus-based steroid avoidance in renal transplantation with either alemtuzumab induction or, basiliximab induction and mycophenolate mofetil maintenance therapy
    Medical condition: MabCampath / Alemtuzumab will be used as part of the immunosuppression regime following renal transplant.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-001664-34 Sponsor Protocol Number: 12028-FC-SS Start Date*: 2013-08-30
    Sponsor Name:Belfast HSC Trust [...]
    1. Belfast HSC Trust
    2. Queens University Belfast
    Full Title: Vit-D in CRC - A Randomised Double Blind Placebo-Controlled Clinical Trial Of a Single Oral Cholecalciferol Treatment Against Surrogate End Point Biomarkers (SEBs) In Colon Cancer (CRC) Patients
    Medical condition: Colon cancer
    Disease: Version SOC Term Classification Code Term Level
    16.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-002479-28 Sponsor Protocol Number: MOL-ARDS-002 Start Date*: 2015-09-24
    Sponsor Name:Justus-Liebig University
    Full Title: GM-CSF Inhalation to improve HOst defense and Pulmonary barrier rEstoration
    Medical condition: Pneumonia associated Acute Respiratory Distress Syndrome (ARDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10000036 A.R.D.S. LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005638-20 Sponsor Protocol Number: CRO-2010-14 Start Date*: 2011-02-18
    Sponsor Name:CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
    Full Title: Phase III randomized trial of preoperative radiotherapy with an integrated simultaneous boost IMRT-IGRT) versus chemoradiotherapy for T3-4 rectal cancer
    Medical condition: Patients with operable rectal cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062099 Rectal neoplasm PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
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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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