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  • 進捗状況
  • 試験名
  • 対象疾患名
  • 地域
  • 登録日
  •  

  • Authorised

  • Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects with CML
  • Subjects with Chronic Myeloid Leukemia (CML) in Accelerated Phase (AP) or in Myeloid (My) or Lymphoid (Ly) Blast Phase (BP) or with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) who are Resistant or Intolerant to Imatinib Mesylate;Therapeutic area: Diseases [C] - Cancer [C04]
  • Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
  • 2005-05-11

  • Authorised

  • An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
  • Hemophilia A Severe hemophilia A MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
  • Australia, Austria, Canada, Czech Republic, European Union, Georgia, Germany, Hungary, Ireland, Italy, Japan, Lebanon, Malaysia, Netherlands, Philippines, Poland, Portugal, South Africa, Spain, Switzerland, Thailand, Ukraine, United Kingdom, United States
  • 2014-05-06

  • Authorised

  • A Clinical Trial to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors
  • Hemophilia A MedDRA version: 20.0 Level: LLT Classification code 10060612 Term: Hemophilia A System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10053751 Term: Hemophilia A with anti factor VIII System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
  • Australia, Belgium, Brazil, Bulgaria, Canada, Colombia, Denmark, Dominican Republic, Finland, Germany, Guatemala, Hungary, Israel, Italy, Mexico, Netherlands, Panama, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Spain, Sweden, Switzerland, United Kingdom
  • 2017-06-12

  • Authorised

  • Safety and efficacy study in patients with untreated follicular non-Hodgkin´s lymphoma.
  • Untreated stage III or IV non-Hodgkin’s lymphoma (CD20+ Follicular Lymphoma of Grade 1, 2 or 3a, requiring chemotherapy) MedDRA version: 14.1 Level: HLT Classification code 10016903 Term: Follicle centre lymphomas, follicular grade I, II, III System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
  • Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Panama, Peru, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
  • 2011-12-06

  • Authorised

  • A TRIAL OF QPI-1007 DELIVERED BY SINGLE OR MULTI-DOSE INTRAVITREAL INJECTION(S) TO SUBJECTS WITH ACUTE OPTIC NEUROPATHY (NAION)
  • NAION typically presents as an abrupt, painless monocular vision loss. Visual loss varies widely, ranging from visual field loss only to complete blindness. The neuronal degeneration process in NAION is thought to occur as primary retinal ganglion cell (RGC) axonal and glial damage from ischemia; Damage to RGC axons causes retrograde death of the associated RGC soma by apoptosis, Neuroprotection of partially damaged RGCs would further limit the loss of visual function MedDRA version: 20.0 Level: LLT Classification code 10068242 Term: Nonarteritic anterior ischaemic optic neuropathy System Organ Class: 100000014125 ;Therapeutic area: Diseases [C] - Eye Diseases [C11]
  • Australia, China, Germany, India, Israel, Italy, United States
  • 2016-07-21

  • Authorised

  • CLCZ696B2319E1 open-label extension (OLE) study to evaluate long-term safety and tolerability of sacubitril/valsartan in pediatric patients with heart failure
  • Pediatric heart failure : Patients (= 13 months) with HF due to systemic left ventricular systolic dysfunction. [Note: All patients per protocol for the core study CLCZ696B2319 (PANORAMA-HF) are to be 1 yr older when they are potentially eligible for entry in the OLE Study CLCZ696B2319E1]. Subjects who turned 18 yrs old during the PANORAMA-HF study, and who qualify, are eligible to participate in the OLE study. Ref section F.1.2 MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
  • Argentina, Austria, Belgium, Bulgaria, Canada, China, Croatia, Czech Republic, Egypt, Finland, France, Germany, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Republic of, Lebanon, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
  • 2019-06-05

  • Authorised

  • A Dolutegravir Open Label Protocol for HIV infected, Adult and Adolescents Patients with Integrase Resistance - Expanded Access Programme
  • Treatment of Human Immunodeficiency Virus (HIV) infection in patients with raltegravir (RAL) or elvitegravir (ELV) resistance who have limited treatment options. MedDRA version: 14.1 Level: LLT Classification code 10020194 Term: HIV-2 infection System Organ Class: 100000004862 MedDRA version: 14.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
  • Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Switzerland, United Kingdom, United States
  • 2012-08-01