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Clinical trials for Laboratory developed tests

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   44336   clinical trials with a EudraCT protocol, of which   7366   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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    89 result(s) found for: Laboratory developed tests. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2010-020113-85 Sponsor Protocol Number: CSLCT-BIO-l0-67 Start Date*: 2011-09-20
    Sponsor Name:CSL Behring GmbH
    Full Title: A Multicentre, Interventional, Non-randomized, Open-label, Single-group Phase III Study to evaluate Plasma-Derived Antihaemophilic Factor/von Willebrand Factor Concentrate (Biostate®) for Immune To...
    Medical condition: Male paediatric subjects with Haemophilia A who develped high titre antibodies to human coagulation Factor VIII
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10018941 Haemophilia NOS LLT
    Population Age: Infants and toddlers, Children, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended) FR (Completed) AT (Completed) GR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-004263-47 Sponsor Protocol Number: EMR200104-011 Start Date*: 2013-03-01
    Sponsor Name:Merck KGaA
    Full Title: Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with adult growth hormone deficiency (AGHD) of adult onset
    Medical condition: Adult Growth Hormone Deficiency
    Disease: Version SOC Term Classification Code Term Level
    17.1 10014698 - Endocrine disorders 10056438 Growth hormone deficiency PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2005-005945-20 Sponsor Protocol Number: IP-REM-GC-02 Start Date*: 2006-06-08
    Sponsor Name:Fresenius Biotech GmbH
    Full Title: Multicenter, open-label and randomized phase II study to evaluate safety and efficacy of the tri-functional bispecific antibody catumaxomab(anti-EpCAM x anti-CD3) in patients after curative resecti...
    Medical condition: Advanced gastric adenocarcinoma and intended curative gastrectomy (R0 resection).
    Disease: Version SOC Term Classification Code Term Level
    8.1 10017812 Gastric neoplasms malignant HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-001714-24 Sponsor Protocol Number: BTA798-CL2-001 Start Date*: 2008-06-18
    Sponsor Name:Biota Scientific Management Pty Ltd
    Full Title: A Phase II, Double-Blind Placebo-Controlled Study to Determine the Prophylactic Efficacy of Oral BTA798 in an Experimental Rhinovirus Challenge Model
    Medical condition: BTA798 is an investigational drug being developed as a potential agent for treatment and prevention of the common cold.
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-003016-87 Sponsor Protocol Number: C3651003 Start Date*: 2023-03-13
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF G...
    Medical condition: Cachexia, a loss of weight due to the catabolism of muscle and fat tissue. The progressive worsening of cachexia impacts a cancer patient’s quality of life and contributes to poor survival.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10064015 Cancer cachexia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Trial now transitioned) HU (Completed) BG (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-002781-21 Sponsor Protocol Number: CO11/9730 Start Date*: 2012-02-02
    Sponsor Name:Leeds Teaching Hospitals
    Full Title: A clinical study to evaluate the biological effects of administering rimantadine in patients with hepatitis C virus (HCV) infection alongside standard combination therapy with pegylated interferon ...
    Medical condition: Hepatitis C Virus infection - genotype 1. Genotype 1 is least responsive to current treatment and is the focus of this study. HCV can cause severe liver damage - this study will only recruit those ...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-005577-20 Sponsor Protocol Number: M14-730 Start Date*: 2016-07-12
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus (HCV) Genotypes 1-6 Infection and Human Immunodeficiency Virus-1 (HIV...
    Medical condition: Hepatitis C Virus Infection Human Immunodeficiency Virus Infection Chronic Hepatitis C Compensated Cirrhosis and Non-cirrhotics
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-004301-27 Sponsor Protocol Number: NIBIT-M2 Start Date*: 2012-11-08
    Sponsor Name:FONDAZIONE NIBIT
    Full Title: A randomized, Phase III study of Fotemustine versus the Combination of Fotemustine and Ipilimumab in Patients with Metastatic Melanoma with brain metastasis
    Medical condition: Subjects (men and women) 18 years old presenting with Stage IV melanoma with presence of brain metastasis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025671 Malignant melanoma stage IV PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-002727-16 Sponsor Protocol Number: IP-CAT-GC-03 Start Date*: 2007-03-06
    Sponsor Name:Fresenius Biotech GmbH
    Full Title: Multicenter, open-label phase II study to evaluate the safety and efficacy of the tri-functional bispecific antibody catumaxomab (anti-EpCAM x anti-CD3) in patients with gastric adenocarcinoma afte...
    Medical condition: Gastric Neoplasm malignant
    Disease: Version SOC Term Classification Code Term Level
    15.0 10017947 - Gastrointestinal disorders 10017812 Gastric neoplasms malignant HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-020559-29 Sponsor Protocol Number: IVF-03-01-052 Start Date*: 2010-09-23
    Sponsor Name:Pantec Biosolutions AG
    Full Title: Proof of concept study to investigate the efficacy, safety and tolerability as well as the pharmacokinetics and pharmacodynamics of a newly developed patch containing follicle-stimulating hormone a...
    Medical condition: Healthy female oocyte donors of normal body weight (body mass index within 18 to 29 kg/m2), age from 20 to 30 years (inclusive), ultrasound of ovaries, normal endocrine status, non-smoker
    Disease: Version SOC Term Classification Code Term Level
    12.0 10021926 Infertility LLT
    12.0 10056204 In vitro fertilisation LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-004294-21 Sponsor Protocol Number: FBT-IVREXBC 02 Start Date*: 2006-03-14
    Sponsor Name:Fresenius Biotech GmbH
    Full Title: Phase II study of the trifunctional anti-HER-2/neu x anti-CD3 antibody ertumaxomab for hormone therapy refractory patients with HER-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer
    Medical condition: Hormone therapy refractory advanced or metastatic breast cancer tumors (stage IIIb or IV) which are known to express HER-2/neu (1+ or 2+)
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) ES (Completed) IT (Prematurely Ended) AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-020832-20 Sponsor Protocol Number: P06356 Start Date*: 2010-08-13
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering Corporation - for Global trials
    Full Title: An Evaluation of the Safety and Pharmacokinetics of Posaconazole (POS, SCH 56592) IV Solution via Peripheral Administration in Healthy Volunteers (P06356)
    Medical condition: This study is going to be conducted in heathy volunteers.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2006-005512-27 Sponsor Protocol Number: B4Z-EW-LYDY Start Date*: 2007-03-12
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperac...
    Medical condition: Attention Deficit Hyperactivity Disorder
    Disease: Version SOC Term Classification Code Term Level
    8.1 10003735 Attention deficit-hyperactivity disorder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) NO (Ongoing) IE (Completed) NL (Not Authorised) GB (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-000359-26 Sponsor Protocol Number: ESTEVE-SANF-201 Start Date*: 2016-04-29
    Sponsor Name:Laboratorios del Dr. Esteve, S.A.
    Full Title: Phase I/II safety, tolerability and initial efficacy study of adeno-associated viral vector serotype 9 containing human sulfamidase gene after intracerebroventricular administration to patients wit...
    Medical condition: Mucopolysaccharidosis type IIIA (Sanfilippo A syndrome) is an inherited lysosomal storage disease caused by a specific lysosomal enzyme deficiency that leads to intracellular accumulation of the ...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-015079-29 Sponsor Protocol Number: 3133K1-3002-WW Start Date*: 2010-01-22
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
    Full Title: A Phase 3 Extension, Multicenter, Double-blind, Parallel-Group, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotei...
    Medical condition: Alzheimer Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Prematurely Ended) BE (Prematurely Ended) ES (Prematurely Ended) PT (Prematurely Ended) SK (Prematurely Ended) IT (Prematurely Ended) FI (Prematurely Ended) NL (Prematurely Ended) SE (Prematurely Ended) AT (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-015080-13 Sponsor Protocol Number: 3133K1-3003-WW Start Date*: 2010-01-22
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
    Full Title: A Phase 3 Extension, Multicenter, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotein E ε4 Carriers and Participat...
    Medical condition: Alzheimer Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012271 Dementia Alzheimer's type PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Prematurely Ended) BE (Prematurely Ended) ES (Prematurely Ended) PT (Prematurely Ended) SK (Prematurely Ended) IT (Prematurely Ended) FI (Prematurely Ended) NL (Prematurely Ended) SE (Prematurely Ended) AT (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004899-19 Sponsor Protocol Number: UC-BCG-1911 Start Date*: 2020-06-09
    Sponsor Name:UNICANCER
    Full Title: Adjuvant PalbOciclib + LetrOzole combination for hormone receptor positive / HER2-negative, Intermediate Risk breast cancer
    Medical condition: Hormone receptor (HR) positive / HER2-negative localized breast cancer in menopausal patient considered as having an intermediate risk of relapse.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2005-000346-36 Sponsor Protocol Number: BPLG-004 Start Date*: Information not available in EudraCT
    Sponsor Name:BioPartners GmbH [...]
    1. BioPartners GmbH
    2. LG Life Science Ltd.
    Full Title: A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Dai...
    Medical condition: pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion
    Disease: Version SOC Term Classification Code Term Level
    10056438 LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) FI (Prematurely Ended) SE (Prematurely Ended) SK (Completed) HU (Completed) CZ (Prematurely Ended) IT (Completed) DE (Completed) LT (Prematurely Ended) EE (Prematurely Ended) LV (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-012118-27 Sponsor Protocol Number: 38518168ARA2001 Start Date*: 2009-10-27
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial B...
    Medical condition: JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039075 Rheumatoid arthritis and associated conditions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) GB (Prematurely Ended) CZ (Prematurely Ended) ES (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-002326-24 Sponsor Protocol Number: ALKS4230-007 Start Date*: 2023-02-13
    Sponsor Name:Mural Oncology, Inc.
    Full Title: A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator’s Choice Chemotherapy in Patients With Platinum-Resistant Epithelial O...
    Medical condition: Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10016180 Fallopian tube cancer PT
    20.1 10022891 - Investigations 10080244 Peritoneal cancer index PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) PL (Completed) IT (Trial now transitioned) NO (Trial now transitioned) AT (Ongoing) LT (Trial now transitioned) BE (Trial now transitioned) DK (Trial now transitioned)
    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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