海外の治験の状況「1」での検索結果
379件の検索結果
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Authorised
- A clinical study to determine the efficacy and safety of tisagenlecleucel, an investigational therapy, in first-line high-risk children and adolescent patients with B-cell acute lymphoblastic leukemia who are minimal residual disease positive at the end of consolidation therapy
- Pediatric and young adult patients aged 1 to 25 years with first-line NCI high-risk (HR) B-cell acute lymphoblastic leukemia (B-ALL) who are in CR1 with minimal residual disease (MRD) positive (MRD = 0.01%) at the end of consolidation (EOC) therapy by central laboratory assessment. MedDRA version: 20.0 Level: LLT Classification code 10063625 Term: Acute lymphoblastic leukemia recurrent System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10063621 Term: Acute lymphoblastic leukaemia recurrent System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
- Belgium, Canada, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom, United States
- 2018-07-13
Authorised
- A clinical study to determine the efficacy and safety of tisagenlecleucel, an investigational therapy, in first-line high-risk children and adolescent patients with B-cell acute lymphoblastic leukemia who are minimal residual disease positive at the end of consolidation therapy
- Pediatric and young adult patients aged 1 to 25 years with first-line NCI high-risk (HR) B-cell acute lymphoblastic leukemia (B-ALL) who are in CR1 with minimal residual disease (MRD) positive (MRD = 0.01%) at the end of consolidation (EOC) therapy by central laboratory assessment. MedDRA version: 20.0 Level: LLT Classification code 10063625 Term: Acute lymphoblastic leukemia recurrent System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10063621 Term: Acute lymphoblastic leukaemia recurrent System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
- Belgium, Canada, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom, United States
- 2018-07-11
Authorised
- Study of allopurinol to prevent kidney function loss in type 1 diabetes
- Type 1 diabetes, microalbuminuria or macroalbuminuria and mildly impaired kidney function. MedDRA version: 19.1 Level: LLT Classification code 10037827 Term: Raised serum uric acid System Organ Class: 100000004848 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Canada, Denmark, United States
- 2014-02-07
Authorised
- A pilot study of allopurinol to prevent kidney function loss in type 1 diabetes
- Type 1 diabetes, microalbuminuria or macroalbuminuria and mildly impaired kidney function.;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Denmark, United States
- 2012-09-10
Authorised
- A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic Acid
- Primary biliary cirrhosis br>MedDRA version: 20.0 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Australia, Austria, Belgium, Canada, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, United States
- 2012-02-13
Authorised
- Immunogenicity and safety study of 1 and 2 doses of meningococcal vaccine MenACWY-TT in toddlers, persistence up to 5 years after vaccination and co-administration with pneumococcal vaccine Prevenar 13™
- Meningococcal disease MedDRA version: 20.0 Level: LLT Classification code 10028911 Term: Neisseria meningitidis infection NOS System Organ Class: 100000019716 MedDRA version: 20.0 Level: LLT Classification code 10070124 Term: Neisseria meningitidis test positive System Organ Class: 100000109761 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Australia, Canada, Czech Republic, Turkey
- 2013-08-14
Authorised
- Safety and efficacy study of roxadustat to treat anemia in patients with lower risk Myelodysplastic Syndrome (MDS), who require 1 to 4 packs of Red Blood Cells through transfusion every 8-weeks.
- Anemia due to Myelodysplastic Syndrome (MDS) in International Prognostic Scoring System – Revised Very Low, Low, or Intermediate Risk with 1 to 4 packed red blood cell units per 8-week period) ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Australia, Belgium, Brazil, Germany, Israel, Italy, Korea, Republic of, Poland, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States
- 2017-08-18
Authorised
- Safety and efficacy study of roxadustat to treat anemia in patients with lower risk Myelodysplastic Syndrome (MDS), who require 1 to 4 packs of Red Blood Cells through transfusion every 8-weeks.
- Anemia due to Myelodysplastic Syndrome (MDS) in International Prognostic Scoring System – Revised Very Low, Low, or Intermediate Risk with 1 to 4 packed red blood cell units per 8-week period);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Australia, Belgium, Canada, France, Germany, Israel, Italy, Korea, Republic of, Netherlands, Poland, Spain, Taiwan, United Kingdom, United States
- 2017-08-08
Authorised
- Safety and efficacy study of roxadustat to treat anemia in patients with lower risk Myelodysplastic Syndrome (MDS), who require 1 to 4 packs of Red Blood Cells through transfusion every 8-weeks.
- Anemia due to Myelodysplastic Syndrome (MDS) in International Prognostic Scoring System – Revised Very Low, Low, or Intermediate Risk with 1 to 4 packed red blood cell units per 8-week period) ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Australia, Belgium, Canada, France, Germany, Israel, Italy, Korea, Republic of, Netherlands, Poland, Spain, Taiwan, United Kingdom, United States
- 2017-07-31
Authorised
- A Study of ARRY-371797 in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation
- Dilated Cardiomyopathy (DCM) with Lamin A/C protein (LMNA) Mutation MedDRA version: 20.0 Level: LLT Classification code 10056419 Term: Dilated cardiomyopathy System Organ Class: 100000004849 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Argentina, Belgium, Canada, Denmark, France, Germany, Italy, Mexico, Netherlands, Norway, Spain, United Kingdom, United States
- 2018-05-17
