治験一覧
8,963 件中 5981〜6000 件を表示
進行がんまたは再発がんに対するモガムリズマブの第Ia/Ib相多施設共同臨床試験。
The purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory T cell depletion with Mogamulizumab for advanced or recurrent cancer patients.
進行性難治性固形腫瘍患者を対象としたBAY1179470のヒト初回投与量漸増試験
An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors
日本人1型糖尿病患者における、新規インスリングラルギン製剤およびランタス®の反復投与による24時間血糖プロファイルへの影響に関する研究
Primary Objective: \- To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state Secondary Objectives: * To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments; * To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c)); * To compare the occurrence of hypoglycemia between the 2 treatments; * To assess the safety and tolerability of a new formulation of insulin glargine.
欧州・日本共同によるEGFR検査診断研究
This is a non-interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and Europe and will assess the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA. The data generated will inform the use of less-invasive sample types in diagnostic practice. The study also aims to assess the current status of EGFR mutation testing across Japan and Europe and gaps in currently available data including EGFR mutation frequency in particular populations and demographic subgroups, EGFR mutation frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology, utility of multiple sample types in the assessment of EGFR mutation status, and impact of EGFR mutation status on therapy choice. The data may be used to drive improvements to the EGFR mutation testing process, ensuring that patients have access to testing and are treated appropriately on the basis of the molecular features of their disease.
Z-360とプラセボを用いた健康被験者試験
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (including food effect) of single and multiple doses of Z-360 in healthy Japanese subjects.
ヌーナン症候群による低身長に対するNN-220（ソマトロピン）2用量の長期有効性および安全性の検討
This trial is conducted in Asia. The aim of the trial is to investigate the long-term efficacy and safety of two doses of NN-220 (somatropin) in short stature due to Noonan syndrome.
血液透析を受けている慢性腎臓病患者における血漿濃度および安全性の検討
This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after oral administration to patients with chronic kidney disease undergoing hemodialysis.
進行性固形悪性腫瘍を有する日本人患者におけるオラパリブ錠の安全性および忍容性の調査
The objective of this study will be to investigate the safety and tolerability of olaparib tablet when given orally to Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.
2型糖尿病患者におけるメトホルミンおよび／またはチアゾリジンジオン系薬剤への追加療法としてのセマグルチド週1回投与とシタグリプチン1日1回投与の有効性および安全性
This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.
進行性固形腫瘍患者におけるMEDI4736の安全性、忍容性および薬物動態を評価するための第I相、非盲検、多施設共同試験
This is a phase I, open-label, multicentre study of MEDI4736 administered intravenously with a standard 3+3 dose-escalation phase to evaluate safety, tolerability, and pharmacokinetics in patients with advanced solid tumor followed by an expansion phase in patients with advanced solid tumors.
日本における心臓足首血管指数（CAVI）の有用性を評価するための前向き多施設共同研究
The objective of this five-year prospective observational follow-up study is to examine the additional benefits of using cardio-ankle vascular index (CAVI) as a predictive indicator of cardiovascular events in high-risk patients.
高齢大腸がん患者における腹腔鏡手術と開腹手術の比較評価試験
Elderly patients have poorer preoperative conditions than younger patients. Therefore, minimally invasive surgery should be an effective treatment method for elderly patients. The investigators conducted a randomized trial that compared laparoscopic surgery and conventional open surgery in elderly patients who were 75 years old or over. The purpose of the present study was to clarify the effect of laparoscopic surgery in elderly patients. In our hypothesis of this trial, laparoscopic surgery is superior to conventional open surgery in short-term results, and same outcome in long -term results. Therefore, laparoscopic surgery would be recommended as standard procedure in an elderly colorectal patient.
KHK4827の第2相臨床試験
This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled, parallel group study. Pharmacokinetics of KHK4827 will also be assessed.
腎臓移植患者における貧血の改善と天然ビタミンDの補給
The purpose of this study is to evaluate the effect of anemia correction and vitamin D supplementation in kidney transplant recipients.
日本人2型糖尿病患者におけるアルビグルチドと経口血糖降下薬単剤療法との併用による長期安全性および有効性を評価する研究
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.
早期および進行期のパーキンソン病（PD）患者における1日18～24mgのロピニロール徐放錠（CR錠）の有効性を評価する研究。
This study is a Phase III, multicentre, randomized, initial double-blind study with subsequent open label phases. The study will havea screening phase (4 weeks), a dose increase effect verification phase (12 weeks), a down titration 1 phase (1 week), a long-term phase (39 weeks), down titration 2 phase (1 to 2 weeks) and a follow up phase. Subjects will be assigned to Ropinirole CR high-dose group or Ropinirole CR maintenance group at a ratio of 3:1. This study is being conducted to evaluate the efficacy (effect of increasing Ropinirole dose from 16 mg/day to 18-24 mg/day) of the Ropinirole CR tablets in early and advanced PD patients who have not achieved an optimal therapeutic response with marketed Ropinirole Immediate release (IR) (15 mg/day) or marketed Ropinirole CR (16 mg/day) formulations.
日本人C型肝炎患者を対象とした、アスナプレビルとダクラタスビルの併用療法とテラプレビル療法との比較に関する第3相臨床試験
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subject. The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects
透析を受けていない高リン血症を伴う慢性腎臓病患者を対象としたASP1585の第3相試験
This is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.
新規マントル細胞リンパ腫患者におけるブルトン型チロシンキナーゼ阻害剤イブルチニブとベンダムスチンおよびリツキシマブの併用療法に関する研究
The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.
通年性アレルギー性鼻炎の小児患者を対象としたTAU-284の長期試験
The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.