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Clinical trials for Biological therapy

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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    1,034 result(s) found for: Biological therapy. Displaying page 1 of 52.
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    EudraCT Number: 2011-004868-30 Sponsor Protocol Number: PNET5MB Start Date*: 2013-10-31
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: AN INTERNATIONAL PROSPECTIVE TRIAL ON MEDULLOBLASTOMA (MB) IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH WNT BIOLOGICAL PROFILE (PNET 5 MB – LR and PNET 5 MB – WNT-HR), AVERAGE-RISK BIOLOGICAL PROFILE (...
    Medical condition: Children with medulloblastoma. Medulloblastoma is a highly cellular malignant embryonal neoplasm.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027107 Medulloblastoma PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) FR (Trial now transitioned) FI (Trial now transitioned) SE (Trial now transitioned) ES (Ongoing) GB (GB - no longer in EU/EEA) AT (Ongoing) NO (Completed) CZ (Trial now transitioned) NL (Trial now transitioned) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004012-10 Sponsor Protocol Number: MODIFI Start Date*: 2021-06-17
    Sponsor Name:UZ Leuven
    Full Title: Model-informed infliximab dose de-escalation following earlier dose escalation in adult patients with inflammatory bowel diseases
    Medical condition: Inflammatory bowel diseases - Crohn's disease - ulcerative colitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-004160-32 Sponsor Protocol Number: 004670 Start Date*: 2006-11-15
    Sponsor Name:Queen Mary's University of London
    Full Title: Biological effects of Goal Directed Therapy in surgical patients
    Medical condition: Post-operative complications in patients who undergo major surgery
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-002251-33 Sponsor Protocol Number: 01 Start Date*: 2006-10-10
    Sponsor Name:University of Vienna
    Full Title: Hypoxia Imaging with the novel Radiopharmaceutical 18F Fluoroazomycin Arabinoside (FAZA)- Prognostic impact in Cervical Cancer .
    Medical condition: Twenty-five patients with cervical carcinoma (T2Nx or TxN1) will be included in the present study. In addition to the routine pre-therapeutical staging of cervical cancer, 18FAZA PET will be perfor...
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-014491-21 Sponsor Protocol Number: Start Date*: 2009-12-17
    Sponsor Name:Cambridge University Hospitals NHS Trust
    Full Title: Neoadjuvant docetaxel prior to radical prostatectomy for high risk localised prostate cancer. Evaluation of biological and functional imaging surrogates of therapy efficacy.
    Medical condition: Neoadjuvant docetaxel prior to radical prostatectomy for high risk localised prostate cancer. Evaluation of biological and functional imaging surrogates of therapy efficacy
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004250-17 Sponsor Protocol Number: RG_18-205,BN3010 Start Date*: 2019-10-11
    Sponsor Name:University of Birmingham
    Full Title: An International Prospective Trial on High-Risk Medulloblastoma in Patients Older than 3 Years
    Medical condition: Histologically proven high-risk medulloblastoma, with any of the currently defined histological subtypes. High-risk disease is defined as patients with sonic hedgehog (SHH) subgroup or non-SHH/non-...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027107 Medulloblastoma PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) AT (Trial now transitioned) DK (Trial now transitioned) IT (Trial now transitioned) NO (Trial now transitioned) NL (Trial now transitioned) BE (Trial now transitioned) SE (Trial now transitioned) CZ (Trial now transitioned) DE (Trial now transitioned) FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-005544-79 Sponsor Protocol Number: Beau_Resp_05_001 Start Date*: 2006-03-24
    Sponsor Name:The Clinical Research Centre, RCSI Education and Research Centre
    Full Title: Adalimumab (Humira) as add-on therapy in the treatment of patients with severe persistent therapy resistant asthma
    Medical condition: Severe Asthma
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-015888-14 Sponsor Protocol Number: V1 Start Date*: 2010-05-06
    Sponsor Name:Fa.Elexxion
    Full Title: Micro-biological and clinical evaluation of the results after adjuvanter laser therapy with 810nm diode laser in frame the parodontologic basis therapy
    Medical condition: Paradontosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-005688-32 Sponsor Protocol Number: CD-FNB Start Date*: 2009-07-02
    Sponsor Name:Univeristy Hospital Na Bulovce
    Full Title: Biological therapy in the prevention of Crohn`s disease recurrence after resection in ileocecal region.
    Medical condition: Prevention of Crohn`s disease recurrence after surgery in ileocecal region by postoperative application of infliximab (four infusions).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011401 Crohn's disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-001410-17 Sponsor Protocol Number: IGNG-0629 Start Date*: 2007-05-31
    Sponsor Name:LFB SA
    Full Title: LONG-TERM SAFETY AND EFFICACY STUDY OF IGNG, A NEW LIQUID PREPARATION OF HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE, ADMINISTERED IN CURRENT PRACTICE TO PRIMARY IMMUNODEFICIENT PATIENTS
    Medical condition: Primary Immunodeficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064859 Primary immunodeficiency syndrome LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-004128-32 Sponsor Protocol Number: KZM-PSMA-01 Start Date*: 2017-12-01
    Sponsor Name:Fakultní nemocnice Plzeň
    Full Title: Imaging of the prostate tumors using PET/CT and PET/MRI with the ligand of the prostatic specific membrane antigene 68Ga-PSMA-11
    Medical condition: prostatic carcinoma higly suspected or its staging or restaging
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002548-21 Sponsor Protocol Number: ProgettoAIRCId.21939 Start Date*: 2021-01-12
    Sponsor Name:FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
    Full Title: Personalized therapy of metastatic thyroid cancer: biological characterization and optimization with 124I PET dosimetry
    Medical condition: metastatic thyroid cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076603 Poorly differentiated thyroid carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    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: 2012-004482-40 Sponsor Protocol Number: OPTIBIO-2012 Start Date*: 2013-06-18
    Sponsor Name:FRANCISCO J. BLANCO GARCÍA
    Full Title: Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with ...
    Medical condition: Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-003787-24 Sponsor Protocol Number: PM-CARE-PNRR-MAD-2022-12375905 Start Date*: 2023-04-20
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: Precision Medicine in patients with unresectable CholAngiocarcinoma; RadioEmbolization and combined biological therapy (Single arm, multicenter phase II study investigating the efficacy and safety...
    Medical condition: Unresectable intrahepatic cholangiocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073077 Intrahepatic cholangiocarcinoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008593 Cholangiocarcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-011675-79 Sponsor Protocol Number: ACTIM Start Date*: 2009-07-10
    Sponsor Name:CH-Versailles
    Full Title: A PHASE II STUDY TO ASSESS EFFICACY AND SAFETY OF PIOGLITAZONE (ACTOS®) AS ADD-ON THERAPY TO IMATINIB MESYLATE (GLEEVEC®) IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN MAJOR...
    Medical condition: chronic phase chronic myelogenous leukaemia (CP-CML) patients in major molecular response.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004524-41 Sponsor Protocol Number: KFE-2022 Start Date*: 2020-12-03
    Sponsor Name:Aarhus University Hospital/Karen-Lise Garm Spindler
    Full Title: OPTIMISE: OPTIMIzation of treatment SElection and follow up in oligometastatic colorectal cancer - a ctDNA guided phase II randomized approach
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10010035 Colorectal cancer stage IV PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001970-41 Sponsor Protocol Number: 20170508 Start Date*: 2017-12-21
    Sponsor Name:MD, PhD Salome Kristensen
    Full Title: Dose reduction and discontinuation of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months randomised, open label, par...
    Medical condition: Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004859 10040107 Seropositive rheumatoid arthritis LLT
    23.1 100000004859 10062719 Seronegative rheumatoid arthritis LLT
    21.0 100000004859 10037160 Psoriatic arthritis LLT
    20.0 100000004859 10076297 Non-radiographic axial spondyloarthritis LLT
    21.1 100000004859 10041672 Spondylitis ankylosing LLT
    20.0 100000004859 10002557 Ankylosing spondylitis and other inflammatory spondylopathies LLT
    21.0 100000004859 10045966 Unspecified inflammatory spondylopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-002109-38 Sponsor Protocol Number: AV-951-08-104 Start Date*: Information not available in EudraCT
    Sponsor Name:AVEO Pharmaceuticals, Inc.
    Full Title: A Phase 1b/2a, Open-Label, Multi-Center Study of AV-951 in Combination with Paclitaxel in Subjects with Advanced or Metastatic Breast Cancer
    Medical condition: Advanced or metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-012350-20 Sponsor Protocol Number: MSC-KTx Start Date*: 2008-01-14
    Sponsor Name:AZIENDA OSPEDALIERA "OSPEDALI RIUNITI DI BERGAMO" (A.O. DI RILIEVO NAZIONALE)
    Full Title: MESENCHYMAL STEM CELLS UNDER BASILIXIMAB/ LOW DOSE RATG TO INDUCE RENAL TRANSPLANT TOLERANCE
    Medical condition: Patients will be those receiving a living-related kidney transplant
    Disease: Version SOC Term Classification Code Term Level
    15.1 10021428 - Immune system disorders 10023439 Kidney transplant rejection PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    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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