治験一覧
8,963 件中 5521〜5540 件を表示
メルケル細胞癌患者におけるアベルマブの有効性（JAVELIN Merkel 200）
This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC).
慢性C型肝炎ウイルス（HCV）遺伝子型1型感染症の日本人患者におけるソホスブビル／レジパスビル±リバビリンの有効性および安全性
This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.
ブレンツキシマブ ベドチン（遺伝子組換え）静脈内投与用 - 特別薬物使用監視（全症例監視）「再発または難治性のCD30陽性ホジキンリンパ腫または未分化大細胞リンパ腫」
The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (IV) infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as well as to collect efficacy information for reference.
細胞培養由来インフルエンザワクチンASP7374の研究
The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in adults ≥20 and \<65 years.
膝関節変形性関節症の保存的治療に関する集中的レジストリ
The primary objective of this registry is to assess the functional outcome measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS) for patients with medial unicompartmental osteoarthritis and osteonecrosis of the knee treated conservatively. The aim of the Focused Registry is to complete the data collection and enable a sound analysis for the Tomofix Small size study.
アログリプチン錠の特別薬物使用監視：軽度の2型糖尿病
The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.
クローン病患者におけるMT-1303の薬物動態（PK）、薬力学（PD）および安全性に関する研究
The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303 in subjects with Crohn's disease.
赤血球生成刺激剤に対する反応性が低い貧血を伴う慢性腎臓病患者の腎予後
This is an observational clinical research on patients with chronic kidney disease who are not on hemodialysis and receiving darbepoetin alfa to treat diagnosed renal anemia; the major objective is to explore novel erythropoiesis stimulating agent (ESA) response index in association with deterioration of renal function as well as occurrence of cardiovascular disease events.
切除可能なHER2陽性原発性乳がん患者を対象とした、アントラサイクリン系薬剤投与後のトラスツズマブ エムタンシン（カドサイラ）＋ペルツズマブ（パージェタ）併用療法と、アントラサイクリン系薬剤投与後のトラスツズマブ（ハーセプチン）＋ペルツズマブ＋タキサン系薬剤併用療法との比較による術後補助療法に関する研究
This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.
テルミサルタン80mg/アムロジピン5mg/ヒドロクロロチアジド12.5mg（T80/A5/H12.5mg）配合錠とT80/H12.5mg錠およびA5mg（Encap A2.5mg錠×2）の併用におけるテルミサルタンの生物学的同等性試験
To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).
再発性または難治性の低悪性度B細胞非ホジキンリンパ腫（iNHL）または慢性リンパ性白血病（CLL）を有する日本人被験者におけるイデラリシブの安全性、忍容性、および薬物動態を評価するための研究
The primary objective of this study is to evaluate the 28-day safety and tolerability, and to determine the pharmacokinetics (PK) of idelalisib in Japanese participants with relapsed or refractory indolent B-cell non-Hodgkin lymphomas (iNHL) or chronic lymphocytic leukemia (CLL).
クロストリジウム・ディフィシル関連下痢症（CDAD）患者におけるOPT-80（フィダキソマイシン）とバンコマイシンの安全性および有効性を比較する研究
The primary objective of this study is to investigate the safety and efficacy of OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
健康な日本人成人を対象としたAPD356（ロルカセリン）の研究
The purpose of this study is to assess the safety and pharmacokinetics of APD356 in healthy Japanese adult subjects. Regarding cohorts 1 to 3, this study is a single center, placebo-controlled, randomized,double-blind study. Regarding cohort 4, this study is a single center, randomized, open-label study that consists of two sequential two-way crossover studies. The study consists of 4 cohorts. In cohort 1, subjects will be randomized to 10 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In cohort 2, subjects will be randomized to 20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug. In cohort 3, subjects will be randomized to XR-20 mg group (6 subjects) or placebo group (2 subjects) to receive single dose of study drug on Day 1 and multiple doses of study drug on Day 8-14 once daily before breakfast. In cohort 4, subjects will be randomized to Sequence A (8 subjects) or Sequence B (8 subjects) to receive study drug in the sequence shown below. Sequence A: 10 mg tablet, 2 doses (12 hours apart) =\> XR-20 mg orange tablet, single dose =\> XR-20 mg orange tablet, q. d., multiple doses (fasted) =\> XR-20 mg orange tablet, q. d., multiple dose (fed) Sequence B: XR-20 mg orange tablet, single dose =\> 10 mg tablet, 2 doses (12 hours apart) =\> XR-20 mg orange tablet, q. d., multiple dose (fed) =\> XR-20 mg orange tablet, q. d., multiple doses (fasted)
日本人潰瘍性大腸炎患者を対象としたMEDI7183の第2相臨床試験
This is a multi-centre, randomised, double-blind, placebo controlled, parallel group, Phase II study to evaluate efficacy and safety of 3 doses of MEDI7183, in Japanese subjects with moderate to severe UC
帯状疱疹患者を対象としたASP2151の第III相臨床試験
To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster.
抗血小板薬併用療法におけるシロスタゾールによる脳卒中予防に関する研究
To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for secondary prevention of ischemic stroke in high-risk patients for stroke
ASP1517第2相臨床試験 - 透析を受けていない慢性腎臓病患者の貧血治療におけるASP1517の二重盲検試験 -
This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently.
局所進行性切除不能または転移性軟部組織肉腫患者を対象としたTH-302の日本における臨床試験
This is a Phase 2, single-arm, Japanese multicenter trial to evaluate the safety, tolerability, and efficacy of TH-302 in combination with doxorubicin in subjects with locally advanced unresectable or metastatic soft tissue sarcoma (STS).
CD19 CAR遺伝子導入Tリンパ球を用いたB細胞非ホジキンリンパ腫の遺伝子治療
The purpose of this study is to evaluate the safety, efficacy and blood kinetics of autologous T cells genetically modified to express anti-CD19 Chimeric Antigen Receptor in patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma.
日本における動脈内狭窄による機能的意義の遠位評価に関する研究
To investigate whether instantaneous wave-Free Ratio(iFR)/Fractional Flow Reserve(FFR) guided treatment strategy makes the postulated treatment strategy by Coronary Angiogram(CAG) guide change and to analyze the cost-effectiveness of its dual diagnosis. To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score evaluated physiological assessment of coronary stenosis and its clinical effectiveness.