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• Authorised

• Phase 1/2 trial to test Nivolumab in treatment failure of Acute Myeloid Leukemia (AML) after stem cell transplantation by a allogenic donor (allo-SCT)
• Acute myeloid leukemia relapse after allo-HCT MedDRA version: 20.0 Level: LLT Classification code 10001941 Term: AML System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10066572 Term: AML progression System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Germany
• 2018-01-10

• Authorised

• Evaluation of unfavourable outcome-related factors in patients affected by renal cell cancer in treatment with everolimus and previously treated with a VEGF inhibitor (i.e. sunitinib, sorafenib,pazopanib, or bevacizumab+interferon)
• metastatic renal cell carcinoma in progression after a first line treatment with a VEGF inhibitor. MedDRA version: 17.1 Level: PT Classification code 10067946 Term: Renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Italy
• 2015-01-09

• Authorised

• HEP002 is a clinical study designed for paediatric patients with urea cycle disorders (UCD). UCD patients will receive several infusions of HepaStem. The efficacy as well as the safety of the medicinal product will be assessed during the year following infusions.
• The urea cycle disorders are inborn errors of metabolism that affect the transfer of nitrogen into urea. There are seven disorders to be investigated: carbamoylphosphate synthetase I deficiency [CPS ID], ornithine transcarbamylase deficiency [OTCD], argininosuccinic acid synthetase deficiency [ASSD], argininosuccinic acid lyase deficiency [ASLD], arginase deficiency [ARGD], N-acetylglutamate synthase deficiency [NAGSD], and citrine deficiency. MedDRA version: 18.0 Level: LLT Classification code 10013373 Term: Disorders of urea cycle metabolism System Organ Class: 100000004861 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
• Belgium, Spain
• 2014-07-01

• Authorised

• A new vaccine for babies which adds protection against hepatitis B
• PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type b and infection caused by all known subtypes of hepatitis B virus. MedDRA version: 14.1 Level: LLT Classification code 10054183 Term: Tetanus immunization System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10019743 Term: Hepatitis B virus (HBV) System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: LLT Classification code 10054181 Term: Hepatitis B immunization System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10069593 Term: Pertussis immunization System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10054180 Term: Diphtheria immunization System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10053386 Term: Poliomyelitis vaccine System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10069543 Term: Hemophilus influenzae type b immunization System Organ Class: 10042613 - Surgical and medical procedures ;Therapeutic area: Body processes [G] - Immune system processes [G12]
• United Kingdom
• 2011-09-21

• Authorised

• Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to treat Metastatic Breast Cancer (PATINA)
• HR+/HER2+ metastatic breast cancer MedDRA version: 20.0 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Australia, Germany, Italy, New Zealand, Spain, United States
• 2017-10-23

• Authorised

• Trial of a new drug to prevent the rejection which could occur after a transplantation.
• Adult patiens with sclerotic chronic graft-versus-host disease refractory to second-line treatment. MedDRA version: 20.0 Level: HLT Classification code 10074474 Term: Transplantation complications System Organ Class: 100000109195 MedDRA version: 20.0 Level: LLT Classification code 10067862 Term: Allogeneic stem cell transplantation System Organ Class: 100000022080 MedDRA version: 20.0 Level: PT Classification code 10074555 Term: Transplantation complication System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 20.0 Level: LLT Classification code 10018653 Term: Graft-versus-host disease System Organ Class: 100000020501 MedDRA version: 20.0 Level: LLT Classification code 10067859 Term: Allogenic stem cell transplantation System Organ Class: 100000022080 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Spain
• 2017-07-12

• Authorised

• Ponatinib for Treatment of Patients with CP-CML after treatment with other TKI has failed
• Adult patients (age = 18) with Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) who have proven to be resistant or intolerant to prior first line Tyrosine Kinase Inhibitor Treatment MedDRA version: 20.0 Level: LLT Classification code 10054352 Term: Chronic phase chronic myeloid leukemia System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Germany
• 2018-06-12

• Authorised

• This is an exploratory study (phase 2a) assessing the antitumor activity (capability to control or reduce the tumor itself and/or metastases) of GM102, a monoclonal antibody, administered alone or in combination with a chemotherapy in patients with previously treated colorectal cancer. The open study means that the medical staff, the patient and the sponsor or its delegates know exactly the study treatment given to the patient.
• Patients with locally advanced or metastatic colorectal cancer (CRC), having received at least two lines of therapy for the locally advanced or metastatic CRC disease. MedDRA version: 20.0 Level: PT Classification code 10010030 Term: Colorectal cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10010034 Term: Colorectal cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10010035 Term: Colorectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Czech Republic
• 2018-04-05

• Authorised

• The effect of Triheptanoin on excercise in adults and adolescence with glycogenoses
• Cori Forbe's Disease Also called: glycogen storage disease Type III or debrancher deficiency. Tarui's disease Also called: glycogen storage disease Type VII or phosphofructokinase deficiency. Glycogenin-1 deficiency or glycogen storage disease Type XV. MedDRA version: 20.1 Level: PT Classification code 10053241 Term: Glycogen storage disease type VII System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.1 Level: PT Classification code 10053250 Term: Glycogen storage disease type III System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0 Level: LLT Classification code 10053255 Term: Tarui disease System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0 Level: LLT Classification code 10016983 Term: Forbes' disease System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
• Denmark
• 2018-03-26

• Authorised

• A randomized placebo-controlled double blind study to prevent BOS - VIT001
• A study to prevent the occurence of chronic rejection after lung transplantation. Other points of investigation include lung function evolution, rate of survival, BAL cellularity, infection rate, rate of acute rejection and reflux MedDRA version: 12.1 Level: LLT Classification code 10029888 Term: Obliterative bronchiolitis MedDRA version: 12.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans MedDRA version: 12.1 Level: LLT Classification code 10068805 Term: Follicular bronchiolitis MedDRA version: 12.1 Level: LLT Classification code 10019319 Term: Heart-lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10025127 Term: Lung transplant MedDRA version: 12.1 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10050437 Term: Prophylaxis against heart and lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10051604 Term: Lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10056409 Term: Heart and lung transplant MedDRA version: 12.1 Level: LLT Classification code 10016547 Term: FEV MedDRA version: 12.1 Level: LLT Classification code 10016549 Term: FEV 1 abnormal MedDRA version: 12.1 Level: LLT Classification code 10016550 Term: FEV 1 decreased MedDRA version: 12.1 Level: LLT Classification code 10016553 Term: FEV 1 low
• Belgium
• 2010-09-02

• Authorised

• A Study of Ipatasertib in Combination with Paclitaxel as a Treatment for Patients with PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor–Positive, HER2-Negative Breast Cancer
• Locally advanced or metastatic triple-negative (estrogen receptor, progesterone receptor, and HER2 negative) breast cancer or locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer with PIK3CA/AKT1/PTEN-altered tumor and no prior chemotherapy in the advanced setting MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000020826 MedDRA version: 20.0 Level: LLT Classification code 10072740 Term: Locally advanced breast cancer System Organ Class: 100000020819 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Australia, Belgium, Brazil, Canada, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Macedonia, the former Yugoslav Republic of, Mexico, Peru, Poland, Romania, Russian Federation, Singapore, Slovenia, Spain, Taiwan, Ukraine, United Kingdom, United States
• 2017-07-31

• Authorised

• A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months.
• PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type b and infection caused by all known subtypes of hepatitis B virus. 10069577: Pertussis immunisation 10069543: Hemophilus influenzae type b immunization MedDRA version: 14.1 Level: PT Classification code 10054130 Term: Hepatitis B immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10054129 Term: Diphtheria immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10053386 Term: Poliomyelitis vaccine System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10069543 Term: Hemophilus influenzae type b immunization System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10069577 Term: Pertussis immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10019731 Term: Hepatitis B System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10054131 Term: Tetanus immunisation System Organ Class: 10042613 - Surgical and medical procedures ;PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type b and infection caused by all known subtypes of hepatitis B virus. 10069577: Pertussis immunisation 10069543: Hemophilus influenzae type b immunization MedDRA version: 14.1 Level: PT Classification code 10054130 Term: Hepatitis B immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10054129 Term: Diphtheria immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10053386 Term: Poliomyelitis vaccine System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10069543 Term: Hemophilus influenzae type b immunization System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10069577 Term: Pertussis immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10019731 Term: Hepatitis B System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10054131 Term: Tetanus immunisation System Organ Class: 10042613 - Surgical and medical procedures
• Belgium, Finland, Germany
• 2011-01-04

• Authorised

• BRENTUXIMAB VEDOTIN ASSOCIATED WITH CHEMOTHERAPY IN UNTREATED PATIENTS WITH STAGE I/II UNFAVOURABLE HODGKIN LYMPHOMA - A RANDOMIZED STUDY
• Untreated patients with histologically confirmed CD30+ classical Hodgkin lymphoma (stage I/II), aged > or = 18 and MedDRA version: 17.0 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• France
• 2014-08-25

• Authorised

• Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.
• Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease. MedDRA version: 19.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: HLT Classification code 10052775 Term: Spondyloarthropathies System Organ Class: 100000004859 MedDRA version: 19.0 Level: HLT Classification code 10039078 Term: Rheumatoid arthropathies System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
• Belgium
• 2012-04-11

• Authorised

• Clinical Phase 2 Study to evaluate the efficacy of the bispecific antibody blinatumomab in adult subjects with Philadelphia Positive Acute Lymphoblastic Leukemia (PH+ ALL) that did not respond to previous therapy or that relapsed after initially successful previous therapy.
• Adult patients with relapsed and/or refractory Philadelphia Chromosome- positive B-precursor ALL MedDRA version: 19.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864 MedDRA version: 19.0 Level: LLT Classification code 10063625 Term: Acute lymphoblastic leukemia recurrent System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• France, Germany, Italy, United Kingdom, United States
• 2013-10-10

• Authorised

• A RANDOMIZED PHASE 2 STUDY OF SU011248 VERSUS STANDARD-OF-CARE FOR PATIENTS WITH PREVIOUSLY TREATED, ADVANCED, TRIPLE RECEPTOR NEGATIVE (ER, PR, AND HER2) BREAST CANCER
• Histologically or cytologically proven diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. Documentation of estrogen and progestin receptor (ER/PR) negative status and HER2/neu receptor negative status (ie, FISH negative or immunohistochemistry 0 or +1). MedDRA version: 9.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer
• Bulgaria, Czech Republic, Germany, Hungary, Italy, Spain, United Kingdom
• 2005-10-06

• Authorised

• Study of Durvalumab with Tremelimumab Versus standard of care chemotherapy in lung cancer (NEPTUNE Study).
• Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) in treatment naive patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type tumour pathology. MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Argentina, Brazil, Bulgaria, Chile, China, Denmark, Finland, Greece, Hong Kong, India, Israel, Japan, Korea, Republic of, Malaysia, Mexico, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Sweden, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States
• 2015-11-19

• Authorised

• Estudio de fase 2 de HKI-272 en sujetos con cáncer de pulmón no microcítico avanzado A Phase 2 Study of HKI-272 in Subjects with Advanced Non-Small Cell Lung Cancer
• Agents targeting the epidermal growth factor receptor (EGFR) have made a major impact on the treatment of advanced NSCLC. EGFR tyrosine kinase inhibitors (TKI) erlotinib and gefitinib elicit a dramatic response in some patients with relapsed NSCLC, but resistance to that therapy is significant. Recently it was reported that irreversibly-binding EGFR-TKIs may prove highly effective in patients with EGFR activation mutations, including tumors that have become resistant to erlotinib or gefitinib.
• Hungary, Spain
• 2005-12-21

• Authorised

• A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination with AMG 479 in Subjects with Advanced, Refractory Solid Tumors. -------------------------------------------------------- Estudio abierto de fase 1b/2 con escalada de dosis de AMG 655 en combinación con AMG 479 en sujetos con tumores sólidos refractarios y avanzados.
• Part 1: Advanced, treatment-refractory solid tumors Part 2: Advanced non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic cancer, ovarian cancer, or sarcoma. ------------------------------------------------------------ Parte 1:tumores sólidos refractarios y avanzados. Parte 2:Cáncer de pulmón no microcítico avanzado (CPNM), cáncer colorrectal (CRC), cáncer pancreático, cáncer de ovario o sarcoma. MedDRA version: 9.1 Level: LLT Classification code 10061451 Term: Colorectal cancer MedDRA version: 9.1 Level: LLT Classification code 10033604 Term: Pancreatic cancer MedDRA version: 9.1 Level: LLT Classification code 10033128 Term: Ovarian cancer
• Spain
• 2008-11-18

• Authorised

• Feasibility and safety of preoperative glucose control in patients with type 2 diabetes undergoing cardiovascular surgery
• The objective of this study is to investigate whether a targeted preoperative glucose control before planned cardiac surgery by i.v. insulin infusion (intensified glycemic control, ICG) versus standard care improves postoperative outcome in patients with T2DM. In addition to evaluating involved molecular mechanisms, this study should also strengthen the evidence of guidelines regarding perioperative glucose management of patients with T2DM.;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
• Austria
• 2014-09-02