患者様やご家族など一般の方向け臨床・治癒情報サイト　臨床研究情報ポータルサイト

• 進捗状況
• 試験名
• 対象疾患名
• 地域
• 登録日
•  

• Authorised

• A multicenter study in order to verify the validity of a complete therapy for adult patients affected by newly diagnosed Acute Leukaemia with tumoral cells substituting lymphoid and with an alteration of two chromosomes generating two new ones.
• De Novo Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) MedDRA version: 14.1 Level: LLT Classification code 10000844 Term: Acute lymphoblastic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Italy
• 2012-01-05

• Authorised

• Gastrointestinal behavior of posaconazol in healthy human volunteers
• Suspension: 105 mg posaconazol (2.6 ml Noxafil): 1)with 250 ml water 2)with 250 ml sparkling water 3)with 5 lumps of sugar, dissolved in 250 ml water 3)with 5 lumps of sugar, dissolved in 250 ml of sparkling water. Solution: 105 mg dissolved posaconazol (via Noxafil) by acidification of HCl until pH 1.2: 1)with 250 ml water 2)with 250 ml sparkling water 3)with 5 lumps of sugar, dissolved in 250 ml water 3)with 5 lumps of sugar, dissolved in 250 ml of sparkling water.;Therapeutic area: Body processes [G] - Physiological processes [G07]
• Belgium
• 2013-11-25

• Authorised

• The patients for this trial are to be HIV-1 infected, antiretroviral treatment-experienced, currently receiving nevirapine IR 200 mg BID with a background therapy of fixed-dose combination (FDC) of 3TC + ABC, FTC + TDF or 3TC + /AZT, men and women = 18 years of age, with an HIV-1 viral load of = 50 copies/mL.
• France, Germany, United Kingdom
• 2008-09-26

• Authorised

• New targeted therapy in relapsed EGFR-mutated lung cancer previously treated with EGFR-inhibitors
• Locally advanced or metastatic non-small cell lung cancer where disease has progressed with previous epidermal growth factor receptor tyrosine kinase inhibitor therapy;Therapeutic area: Diseases [C] - Cancer [C04]
• Norway
• 2015-03-23

• Authorised

• Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled study
• Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab) MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
• Denmark, Finland, Norway, Sweden
• 2012-08-01

• Authorised

• An open label phase II study to evaluate the efficacy and safety of Inotuzumab Ozogamicin for Induction Therapy followed by a conventional chemotherapy based consolidation and maintenance therapy In patients aged 56 years and older with Acute Lymphoblastic leukemia (ALL).
• Acute lymphoblastic leukemia, Philadelphia-chromosome and BCR-ABL negative disease, patient aged 56 years or older MedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Germany
• 2017-05-17

• Authorised

• BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS
• Multiple sclerosis results from an auto-immune reaction characterized by inflammation within the nervous system. Myelin basic protein is a target of the autoimmune response and is generally regarded as the predominant autoantigen. BHT-3009 is a 3.5 kb bacterial plasmid expression vector containing the coding sequences for full length human myelin basic protein (hMBP).
• Czech Republic, Finland, United Kingdom
• 2005-07-18

• Authorised

• Functional consequences of decreased RNA expression of certain GABA(A) receptor subunits in fragile X patients using Positron Emission Tomography and [11C]flumazenil. - PET-FRAX-GABA
• Fragile X syndrome is the most common form of inherited mental retardation with a prevalence of 1/4000 males and 1/6000 females. Patients are characterized by a mild to severe form of cognitive impairment and light dysmorphic features. Autism-like behaviour, hyperactivity and epilepsy can also be associated with the disease. On the molecular level the disease is caused by a dynamic mutation of a CGG repeat in the 5' UTR of the FMR1 gene.
• Belgium
• 2008-09-03

• Authorised

• A multi-stage clinical study to develop a non-invasive Short Synacthen Test (SST) with nasally administered synacthen and salivary cortisol. The validated non-invasive SST will be used to establish normative data in children and to detect adrenal suppression in asthmatic children. - The development of a non-invasive Short Synacthen Test - NeSST Study
• In stages 1+2 of the study healthy volunteers will be used to determine the bioequivalence of nasal synacthen with 1 microgram of intravenous synacthen. Stage 3 will use healthy children to establish normal ranges for the adrenal response to a low-dose synacthen test. In stage 4 adrenal function in asthmatic individuals on inhaled corticosteroids will be studied. MedDRA version: 9.0 Level: PT Classification code 10001367 Term: Adrenal Insufficiency MedDRA version: 9.0 Level: PT Classification code 10006482 Term: Bronchospasm
• United Kingdom
• 2010-06-24

• Authorised

• Fulvestrant +/- Akt inhibition in advanced aromatase inhibitor resistant breast cancer
• Estrogen receptor positive advanced breast cancer MedDRA version: 18.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10070577 Term: Oestrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• United Kingdom
• 2014-01-15

• Authorised

• A clinical trial of a Tailored ImmunoTherapy Approach with Nivolumab in subjects with metastatic or advanced Transitional Cell Carcinoma
• subjects in untreated (1st line) and platinum-based pretreated (2nd and 3rd line) subjects with metastatic or surgically unresectable TCC MedDRA version: 20.0 Level: LLT Classification code 10038514 Term: Renal pelvis and ureteric cancer transitional cell metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: PT Classification code 10071664 Term: Bladder transitional cell carcinoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10038509 Term: Renal pelvis and ureteric cancer metastatic transitional cell System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10044423 Term: Transitional cell carcinoma ureter metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10044406 Term: Transitional cell cancer of renal pelvis and ureter metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10038498 Term: Renal pelvis and ureter transitional cell cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: LLT Classification code 10026427 Term: Malignant neoplasm of renal pelvis and ureter localized transitional cell System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: PT Classification code 10066752 Term: Bladder transitional cell carcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Cl;Therapeutic area: Diseases [C] - Cancer [C04]
• Austria, Germany
• 2017-09-04

• Authorised

• A clinical trial of a Tailored ImmunoTherapy Approach with Nivolumab in subjects with metastatic or advanced Transitional Cell Carcinoma
• subjects in untreated (1st line) and platinum-based pretreated (2nd and 3rd line) subjects with metastatic or surgically unresectable TCC MedDRA version: 20.0 Level: LLT Classification code 10038514 Term: Renal pelvis and ureteric cancer transitional cell metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: PT Classification code 10071664 Term: Bladder transitional cell carcinoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10038509 Term: Renal pelvis and ureteric cancer metastatic transitional cell System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10044423 Term: Transitional cell carcinoma ureter metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10044406 Term: Transitional cell cancer of renal pelvis and ureter metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10038498 Term: Renal pelvis and ureter transitional cell cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: LLT Classification code 10026427 Term: Malignant neoplasm of renal pelvis and ureter localized transitional cell System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: PT Classification code 10066752 Term: Bladder transitional cell carcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Cl;Therapeutic area: Diseases [C] - Cancer [C04]
• Austria, Germany
• 2017-02-06

• Authorised

• Randomized, single-blind, clinical and MRI study for evaluation of safety and efficacy of N-Acetyl Cysteine (NAC) associated with high-dose beta-Interferon in Relapsing-Remitting (RR) multiple sclerosis patients - renac
• multiple sclerosis MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive
• Italy
• 2008-03-12

• Authorised

• A Phase III randomised, multicentre, double-blind, therapeutic equivalence study of biosimilar G-CSF (PLIVA/Mayne filgrastim) versus Neupogen (filgrastim-Amgen) in subjects receiving doxorubicin and docetaxel as a combination chemotherapy for breast cancer
• This study is designed to demonstrate the therapeutic equivalence of PLIVA/Mayne filgrastim and Neupogen for the reduction in duration of neutropenia and the incidence of febrile neutropenia, in subjects receiving chemotherapy. MedDRA version: 9.1 Level: LLT Classification code 10029354 Term: Neutropenia
• Bulgaria, Germany, Hungary, Latvia, Poland, Spain, United Kingdom
• 2007-05-15

• Authorised

• Comparación de insulina lispro premezclada (proporción baja) dos veces al día frente a insulina glargina una vez al día e insulina lispro prandial una vez al día, como estrategias de intensificación de la insulinoterapia en pacientes con diabetes tipo 2 que presentan un control glucémico inadecuado con insulina glargina y metformina y/ó pioglitazona Comparison of Twice-Daily Insulin Lispro Low Mixture versus Once-Daily Basal Insulin Glargine and Once-Daily Prandial Insulin Lispro as Insulin Intensification Strategies in Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Basal Insulin Glargine and Metformin and/or Pioglitazone
• Diabetes tipo 2 MedDRA version: 13 Level: LLT Classification code 10067585 Term: Diabetes mellitus tipo 2
• Spain
• 2010-10-18

• Authorised

• 'Stem cell Trial of recovery EnhanceMent after Stroke 3’ (STEMS 3)- a pilot randomised controlled trial of G-CSF and therapy in chronic stroke - Stem cell Trial of recovery EnhanceMent after Stroke 3 (STEMS 3)
• Stroke with residual deficit
• United Kingdom
• 2011-04-15

• Authorised

• Revlimid, Endoxan, Prednisone Evaluation After prior revlimid Treatment (REPEAT): A phase 1 and phase 2 study of lenalidomide (Revlimid) in combination with cyclophosphamide (endoxan) and prednisone (REP) in relapsed/refractory multiple myeloma
• Multiple Myeloma MedDRA version: 18.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
• Netherlands
• 2011-02-23

• Authorised

• Curative and palliative treatment of adults aged > 60 years with AML.A randomised trial by OSHO on the role of (1) early intensification {OSHO protocol} vs. common standard arm of German AML Intergroup Study, (2) allografting as consolidative immunotherapy vs. a second consolidation course in elderly patients,(3) prospective evaluation of the decision between curative and palliative treatment-intention. - AML 2004 OSHO #069
• Acute myelogenous leukemia
• Austria
• 2006-01-02

• Authorised

• STUDY OF PITAVASTATIN 1 MG vs. PRAVASTATIN 10 MG, PITAVASTATIN 2 MG vs. PRAVASTATIN 20 MG AND PITAVASTATIN 4 MG vs. PRAVASTATIN 40 MG (FOLLOWING UP-TITRATION) IN ELDERLY PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR COMBINED DYSLIPIDEMIA
• PRIMARY HYPERCHOLESTEROLEMIA OR COMBINED DYSLIPIDEMIA MedDRA version: 7.1 Level: LLT Classification code 10020604
• Denmark, Germany, United Kingdom
• 2005-06-02

• Authorised

• This study compares intravesical oxybutynin and oral fesoteridine in children with a neurogenic overactive bladder. Both antimuscarinics lower the activity of the overactive bladder and by consequence lower the pressure in the bladder, what is important to protect the higher urinary tract system. Fesoterodine works more bladderspecific, that's why it's better tolerated than oxybutynin. 1 pill of fesoterodine a day would be more practical to use than 2 bladderinstillations of oxybutynin a day.
• children with neurogenic detrusor overactivity MedDRA version: 14.1 Level: PT Classification code 10041524 Term: Spina bifida System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
• Belgium
• 2012-12-11