治験一覧
8,963 件中 5681〜5700 件を表示
熟成ニンニク抽出物の抗酸化作用
This is a randomized, double-blind, placebo controlled, crossover study to determine the antioxidant effect of aged garlic extract. This study will also compare the oxidative status in heavy smokers with that in non-smokers.
プログラム細胞死リガンド1（PD-L1）陽性の局所進行性または転移性非小細胞肺癌患者におけるアテゾリズマブの臨床試験
This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
菊花油の尿酸血症に対する効果とその用量依存性
The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum flower oil in suppressing serum uric acid.
健康な日本人男性被験者を対象としたJNJ-54861911の安全性、忍容性および薬物動態に関する研究
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK, study of the way a drug enters and leaves the blood and tissues over time) of single-ascending oral doses of JNJ-54861911 in healthy Japanese male participants.
原因不明の習慣性流産患者におけるGB-0998の有効性および安全性に関する研究
The present survey was conducted to evaluate the efficacy and safety of GB-0998(immunoglobulin) in the treatment of unexplained recurrent miscarriage in comparison to placebo using a multicenter, double-blind, intergroup comparison method.
吸入ステロイド薬と長時間作用型β2刺激薬を併用している喘息成人および青年におけるベンラリズマブ（MEDI-563）の安全性および忍容性を評価するための安全性延長試験
The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.
HARMONEE - OrbusNEichのコンボステントの無作為化多施設共同研究による日米調和評価
This is a multi-center, single-blind, randomized, active-controlled, clinical trial in Percutaneous Coronary Intervention (PCI) subjects. Subjects will be randomized to receive the Combo stent as the investigational treatment arm or an Everolimus Eluting Stent (EES) as the active-control arm.
X連鎖性低リン血症性くる病/骨軟化症患者におけるKRN23の研究
The objective of this study is to assess the safety and tolerability of KRN23 after a single subcutaneous (SC) administration in subjects with X-linked hypophosphatemic rickets/osteomalacia (XLH) in Japan or Korea.
慢性リンパ性白血病患者を対象としたSyB L-0501の有効性および安全性に関する研究
The purpose of this study is to investigate safety and efficacy of SyB L-0501 after 2-day intravenous infusion at a dose of 100 mg/m2/day to patients with chronic lymphocytic leukemia.
酸性スフィンゴミエリナーゼ欠損症患者におけるオリプダーゼアルファの有効性、安全性、薬力学および薬物動態学的研究
Primary Objective: The primary objective of this phase 2/3 study was to evaluate the efficacy of olipudase alfa (recombinant human acid sphingomyelinase) administered intravenously once every 2 weeks for 52 weeks in adult participants with acid sphingomyelinase deficiency (ASMD) by assessing changes in: 1) spleen volume as measured by abdominal magnetic resonance imaging (MRI) (and, for the United States \[US\] only, in association with participant perception related to spleen volume as measured by splenomegaly-related score \[SRS\]); and 2) infiltrative lung disease as measured by the pulmonary function test, diffusing capacity of the lung for carbon monoxide (DLCO). Secondary Objectives: * To confirm the safety of olipudase alfa administered intravenously once every 2 weeks for 52 weeks. * To characterize the effect of olipudase alfa on the participant perception related to spleen volume as measured by the SRS after 52 weeks of study drug administration. (For the US, the effect of olipudase alfa on the SRS is part of the primary objective). * To characterize the effect of olipudase alfa after 52 weeks of study drug administration on the following outcome measures assessed sequentially: * The effect of olipudase alfa on liver volume; * The effect of olipudase alfa on platelet count; * The effect of olipudase alfa on fatigue; * The effect of olipudase alfa on pain; * The effect of olipudase alfa on dyspnea.
多発性骨髄腫を有する日本人患者における末梢血造血幹細胞の動員および採取のためのプレリキサフォルと顆粒球コロニー刺激因子（G-CSF）の併用療法
Primary Objective: To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 6 x 10\^6 cluster of differentiation (CD) 34+ cells/kg in 2 or fewer days of apheresis than MM patients mobilized with G-CSF alone. Secondary Objectives: * To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in MM patients. * To compare the 2 treatment arms with respect to the number of participants who achieved a minimum of 2 x 10\^6 CD34+ cells/kg in 4 or fewer days of apheresis. * To compare the 2 treatment arms with respect to the number of days of apheresis required to reach the target of greater than or equal to 6 x 10\^6 CD34+ cells/kg.
慢性閉塞性肺疾患（COPD）に対するメポリズマブの追加治療としての有効性と安全性
This is a multi-centered, randomized, placebo-controlled, double-blind, parallel group, trial evaluating 2 doses of mepolizumab against placebo given every 4 weeks through subcutaneous (SC) injection. In severe COPD subjects, sputum eosinophils levels are elevated to similar levels as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD subjects would translate into a reduction of COPD exacerbations. The study will evaluate the efficacy and safety of mepolizumab, in subjects who are at or above the baseline blood eosinophil count of at least 150 cells/microliters who exacerbate despite regular use of maximal tolerated therapy, appropriate for severe COPD subjects, in the 12 months prior to study start. In total, 660 subjects will be randomized in 1:1:1 ratio to receive mepolizumab 300 mg, mepolizumab 100mg, or placebo administered SC. The total duration of subject participation will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.
デュシェンヌ型筋ジストロフィーに対するTAS-205の研究
The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in patients with Duchenne Muscular Dystrophy.
日本人健康男性被験者におけるD961Hのカプセル剤と顆粒剤の薬力学的生物学的同等性試験
The purpose of this study is; To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH\>4. To compare a D961H sachet 20 mg with a D961H HPMC capsule 20 mg by the assessment of percentage of time with intragastric pH\>3 during 24 hours and 24-hour median pH. To compare PK properties of a D961H sachet 20 mg with those of D961H HPMC capsule 20 mg. To evaluate the safety and tolerability of a D961H sachet 20 mg and D961H HPMC capsule 20 mg.
部分発作を有する日本人成人を対象とした、静脈内投与ラコサミドの安全性および忍容性を評価するための非盲検試験
EP0024 is a Phase 3, multicenter, open-label study to evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM). Adjunctive iv LCM therapy (200 mg/day to 400 mg/day) will be administered for 5 days as replacement for oral LCM tablets in Japanese adults with partial-onset seizures.
骨髄線維症患者におけるモメロチニブとルキソリチニブの比較
This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor). Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.
前立腺がん患者におけるASP3550とゴセレリンの効果を比較する研究
To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.
転移性去勢抵抗性前立腺癌患者を対象としたJNJ-56021927の安全性試験
The purpose of this study is to evaluate the safety and tolerability of JNJ-56021927 in Japanese participants with metastatic castration-resistant prostate cancer (mCRPC- prostate cancer that is resistant to medical \[for example. hormonal\] or surgical treatments).
クローン病を有する日本人被験者を対象とした、E6011の反復静脈内投与に関する第1/2相試験
This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated intravenous administration of E6011. A total of 24 subjects will enroll into four cohorts. Six subjects per cohort will receive repeated intravenous administration of E6011.
骨転移が優位なHER2陰性ホルモン受容体陽性転移性乳がん患者を対象とした、ラジウム223ジクロリドとエキセメスタンおよびエベロリムスの併用療法とプラセボとエキセメスタンおよびエベロリムスの併用療法との比較研究
The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.