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Clinical trials for Directly observed 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   44347   clinical trials with a EudraCT protocol, of which   7375   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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    31 result(s) found for: Directly observed therapy. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2012-002094-58 Sponsor Protocol Number: UITB-TBTC-Estudio33 Start Date*: 2012-10-26
    Sponsor Name:Unidad de Investigación en Tuberculosis de Barcelona (UITB)
    Full Title: An evaluation of adherence to LTBI treatment with 12 doses of once weekly rifapentine and isoniazid given as self-administered versus directly-observed therapy: iAdhere
    Medical condition: Adherence study in subjects with Latent Tuberculosis Infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-001004-39 Sponsor Protocol Number: JO-3 Start Date*: 2005-07-05
    Sponsor Name:University of Edinburgh
    Full Title: Investigation of combined phosphodiesterase 5 inhibitor and isosorbide mononitrate for the treatment of resistant hypertension
    Medical condition: Hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-005154-44 Sponsor Protocol Number: OPERA Start Date*: 2006-03-02
    Sponsor Name:Universitätsklinikum Hamburg-Eppendorf
    Full Title: OPERA: OXALIPLATIN AND CETUXIMAB IN FIRST-LINE TREATMENT OF mCRC Open, non-controlled, multicenter phase II study evaluating 5-FU/FA plus oxaliplatin (FOLFOX-4) plus cetuximab as first-line treatme...
    Medical condition: metastasized colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    8.1 10052358 Colorectal cancer metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-005650-41 Sponsor Protocol Number: ML19953 Start Date*: 2006-05-11
    Sponsor Name:SESP
    Full Title: A Comparative, Randomized, Open-label, Multicenter Study, of Directly Observed Treatment of Chronic Hepatitis C (DOT) and auto administrated treatment with Copegus® (Ro 20-9963) and Pegasys® (Ro 25...
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    10008912
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-024557-36 Sponsor Protocol Number: VHCRP1007 Start Date*: 2012-05-29
    Sponsor Name:The Kirby Institute
    Full Title: A phase IV open-label multicentre, international trial of response guided treatment with directly observed pegylated interferon alfa 2b and self-administered ribavirin for patients with chronic HCV...
    Medical condition: Chronic Hepatitis C genotype 2 and 3 infection.
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003192-18 Sponsor Protocol Number: NCT-PMO-1602 Start Date*: 2021-07-08
    Sponsor Name:German Cancer Research Center
    Full Title: Continuous ReAssessment with Flexible ExTension in Rare Malignancies – CRAFT: The NCT PMO-1602 Phase II Trial
    Medical condition: Metastatic or locally advanced malignancies
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003854-99 Sponsor Protocol Number: CLL17 Start Date*: 2021-06-11
    Sponsor Name:University of Cologne
    Full Title: A phase 3 multicentre, randomized, prospective, open-label trial of Ibrutinib monotherapy versus fixed-duration Venetoclax plus Obinutuzumab versus fixed-duration Venetoclax plus Ibrutinib in patie...
    Medical condition: Patients with previously untreated CLL requiring treatment
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008958 Chronic lymphocytic leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Trial now transitioned) IE (Trial now transitioned) SE (Trial now transitioned) NO (Trial now transitioned) DE (Trial now transitioned) AT (Trial now transitioned) NL (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-002076-39 Sponsor Protocol Number: WC42759 Start Date*: 2022-02-25
    Sponsor Name:Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    Full Title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF BALOVAPTAN IN PATIENTS WITH ACUTE ISCHEMIC STROKE AT HIGH RISK OF DEVELOPING MALIG...
    Medical condition: Acute Ischemic Stroke (AIS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10008107 Cerebral edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-000280-23 Sponsor Protocol Number: BISS Start Date*: 2020-08-20
    Sponsor Name:Prof Mathias Abegg
    Full Title: A pragmatic, randomized, non-inferiority trial comparing the effectiveness of Botulinum toxin-based treatment with conventional strabismus surgery in acquired esotropia
    Medical condition: Acquired esotropia (strabismus)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10015475 Esotropia LLT
    20.0 100000004853 10042163 Strabismus NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004024-11 Sponsor Protocol Number: SHP648-101 Start Date*: 2020-05-04
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: An Open-Label, Multinational, Phase 1/2 Study of the Safety and Dose Escalation of SHP648, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing FIX Padua in Hemophilia B Subjects
    Medical condition: Hemophilia B is a X-linked recessive bleeding disorder caused by mutations in the gene encoding clotting factor IX (FIX) that result in disruption of the normal clotting pathway. Hemophilia B affec...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended) HU (Prematurely Ended) ES (Prematurely Ended) AT (Prematurely Ended) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003935-12 Sponsor Protocol Number: ATRiUM Start Date*: 2019-06-13
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
    Full Title: ATRiUM: A phase 1 trial to assess the safety, tolerability, pharmacokinetics and preliminary antitumor activity of ascending doses of combined therapy with ATR inhibitor AZD6738 and gemcitabine, Us...
    Medical condition: Locally advanced or metastatic solid tumour.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10065143 Malignant solid tumour LLT
    20.0 100000004864 10049280 Solid tumour LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-002622-87 Sponsor Protocol Number: BeliVeR Start Date*: 2021-10-27
    Sponsor Name:University Hospital Tuebingen
    Full Title: A phase II trial of belimumab in combination with rituximab/venetoclax in patients with refractory or relapsed chronic lymphocytic leukemia
    Medical condition: Refractory or relapsed chronic lymphocytic leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009310 CLL LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000850-36 Sponsor Protocol Number: 201600136 Start Date*: 2017-05-01
    Sponsor Name:Archivel Farma S.L.
    Full Title: Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients with Multi-Drug Resistant Tuberculos...
    Medical condition: The medical condition to be investigated is culture-confirmed Multidrug-resistant tuberculosis, i.e. tuberculosis resistant to the two first-line drugs Rifampicin and Isoniazid
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-005097-25 Sponsor Protocol Number: KIDS-STEP Start Date*: Information not available in EudraCT
    Sponsor Name:Universitätskinderspital beider Basel (UKBB)
    Full Title: A randomised placebo-controlled multi-centre effectiveness trial of adjunct betamethasone therapy in hospitalised children with community acquired pneumonia (CAP)
    Medical condition: Children with community acquired pneumonia (CAP).
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000576-42 Sponsor Protocol Number: ICORG12-01 Start Date*: 2012-04-05
    Sponsor Name:Cancer Trials Ireland
    Full Title: S1007, A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer ...
    Medical condition: Patients with 1-3 positive Nodes, Hormone Receptor-Positive and Her2-Negative Breast Cancer with recurrence Score (RS) of 25 or Less
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10071113 Node-positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-003947-27 Sponsor Protocol Number: TAK-981-1002 Start Date*: 2021-07-04
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: An Open Label, Dose-Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumor...
    Medical condition: Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies
    Disease: Version SOC Term Classification Code Term Level
    27.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066481 Hematological malignancy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) ES (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002202-20 Sponsor Protocol Number: 213400 Start Date*: 2020-12-07
    Sponsor Name:GlaxoSmithKline Research & Development Ltd.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Dise...
    Medical condition: Non-small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) NL (Trial now transitioned) DE (Trial now transitioned) NO (Trial now transitioned) BE (Trial now transitioned) GR (Trial now transitioned) HU (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-001559-35 Sponsor Protocol Number: SP848 Start Date*: 2012-06-11
    Sponsor Name:UCB BIOSCIENCES, Inc
    Full Title: AN OPEN-LABEL STUDY TO DETERMINE SAFETY, TOLERABILITY, AND EFFICACY OF LONG-TERM ORAL LACOSAMIDE (LCM) AS ADJUNCTIVE THERAPY IN CHILDREN WITH EPILEPSY
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) HU (Completed) IT (Completed) Outside EU/EEA PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-004537-16 Sponsor Protocol Number: MO11/10085 Start Date*: 2013-01-25
    Sponsor Name:University of Leeds
    Full Title: An Open Label Multi-Centre Preoperative Window of Opportunity Study of Afatinib in Stage Ia to IIb Non-Small Cell Lung Cancer
    Medical condition: Non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10025051 Lung cancer non-small cell stage II LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004015-20 Sponsor Protocol Number: CDRB436G2201 Start Date*: 2018-01-09
    Sponsor Name:Novartis Pharma AG
    Full Title: Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or...
    Medical condition: Paediatric patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065443 Malignant glioma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) CZ (Completed) DE (Completed) ES (Ongoing) IT (Completed) FI (Completed) DK (Completed) FR (Completed) NL (Completed) BE (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
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