治験一覧
8,963 件中 4041〜4060 件を表示
非アルコール性脂肪性肝炎患者を対象とした、1日1回皮下投与のセマグルチド3用量レベルとプラセボの有効性および安全性の検討。
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis
関節リウマチ成人患者におけるフィルゴチニブの安全性と有効性を評価する長期継続試験
The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).
転移性膵管腺癌（モルフェウス膵癌）患者における複数の免疫療法に基づく治療の併用に関する研究
A Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of patients who have received no prior systemic therapy for metastatic PDAC, and Cohort 2 will consist of patients who have received one line of prior systemic therapy for PDAC. In each cohort, eligible patients will be assigned to one of several treatment arms.
血友病A患者における皮下注射用トゥロクトコグアルファペゴルの安全性、忍容性、および薬物動態に関する研究
The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.
進行性悪性腫瘍を有する日本人被験者を対象としたペミガチニブの安全性および忍容性に関する研究 - (FIGHT-102)
The purpose of this study is to evaluate the safety and tolerability of pemigatinib in Japanese subjects with advanced malignancies.
未治療進展期小細胞肺癌におけるプラチナ製剤化学療法とデュルバルマブ±トレメリムマブの併用（CASPIAN試験）
This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer
局所進行性または転移性尿路上皮膀胱癌患者を対象としたエンホルツマブベドチンの臨床試験
This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer. This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect. Patients who sign up for this trial must also fall into one of these categories: * Patients have already received treatment with platinum-containing chemotherapy * Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.
進行固形癌患者を対象とした、免疫チェックポイント阻害剤ASP8374の単剤およびペムブロリズマブとの併用による多回投与試験
The primary purpose of this study is to evaluate the tolerability and safety profile of ASP8374 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumor malignancies. Also primary purpose is to characterize the pharmacokinetic profile of ASP8374 when administered as a single agent and in combination with pembrolizumab. Last primary purpose of this study is to determine the recommended Phase 2 dose (RP2D) of ASP8374 when administered as a single agent and in combination with pembrolizumab. The secondary purpose of this study is to evaluate the anti-tumor effect (objective response rate \[ORR\], duration of response \[DOR\], persistence of response after discontinuation, and disease control rate \[DCR\]) of ASP8374 when administered as a single agent and in combination with pembrolizumab. NTP: Neutropenia NHAE:Non-haematological AE GBS: Guillain-Barré syndrome"" IRR: Infusion-related reaction AST: Aspartate aminotransferase ALT: Alanine aminotransferase MS/MG: Myasthenia Syndrome/Myasthenia Gravis TRT: Treatment-related Toxicity TCP: Thrombocytopenia
2型糖尿病患者におけるSGLT-2阻害薬への追加療法としてのセマグルチド週1回投与とプラセボの有効性および安全性
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.
ブリリンタの臨床経験調査
To confirm the following safety topics in patients to be treated with BRILINTA tablets 60 mg or 90 mg (hereinafter referred to as "BRILINTA") in clinical practice in the post-marketing phase. 1. Profile and incidence of ADRs The CEI will be conducted to collect data of the events, especially focusing on bleeding, dyspnoea and bradyarrhythmia so as to investigate onset, outcome, treatment for the event, and risk factors for these events, etc. 2. Profile and incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI 3. Efficacy: Profile and incidence of cardiovascular events (cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke) 4. Factors which may affect safety or efficacy of ticagrelor
高カリウム血症を有する日本人被験者における、最長12ヶ月間のシクロケイ酸ジルコニウムナトリウムの非盲検安全性試験
The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month long-term Maintenance Phase.
顕微鏡的血尿患者における膀胱癌の診断のための新規マルチプレックスELISAアッセイ
To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.
部分発作（二次性全般発作の有無を問わず）または原発性全般強直間代発作を有する成人てんかん患者におけるフィコンパ錠の長期投与の臨床的安全性および有効性の調査
The objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa: 1. unknown adverse drug reactions (ADRs); 2. occurrence of ADRs; 3. factors that are likely to affect safety and efficacy; 4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items; 5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).
中等度から重度の潰瘍性大腸炎またはクローン病患者を対象としたオンタマリマブの安全性延長試験（AIDA）
The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)
進行性または再発性乳がん患者を対象としたKHK2375の第2相臨床試験
The primary objective of this study is to investigate the effect of 5 mg KHK2375 on progression free survival (PFS) when administered orally at weekly intervals in combination with exemestane in a placebo-controlled, double-blind comparative study in subjects with advanced or recurrent hormone receptor-positive breast cancer. The secondary objectives are to investigate the effect of on overall survival (OS) and the antitumor effect and to evaluate the pharmacokinetics and safety.
3Dイメージングを用いた分岐部ステント留置の最適化
The primary purpose of this study is to determine whether bifurcation stenting guided by on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with angiographic guidance by measuring incomplete stent apposition (ISA) in the bifurcation segment.
中等度から重度のアトピー性皮膚炎に対するトラロキヌマブ単剤療法 - ECZTRA 1（ECZema TRAlokinumab試験番号1）
Primary objective: To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo. Maintenance objective: To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.
日本人健康被験者を対象としたGSK2269557の安全性、忍容性および薬物動態を評価する研究
GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase (PI3K) delta inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airway diseases, such as chronic obstructive pulmonary disease (COPD). The purpose of the study is to assess the safety, tolerability and pharmacokinetics (PK) of single and repeat doses of GSK2269557 administered via the ELLIPTA dry powder inhaler (DPI) to healthy Japanese subjects. This is the first time for Japanese subjects that GSK2269557 will be administered via the ELLIPTA DPI with the addition of magnesium stearate. In each group of this study, subjects will receive a single dose of either GSK2269557 or placebo in Session 1 and receive daily dose of GSK2269557 or placebo for 10 days in Session 2. Session 1 of the next dose strength may be run in parallel with the Session 2 of the previous dose. The doses planned for the study are 200 micrograms (mcg), 500 mcg and 700 mcg. There will be at least 10 days washout between the two dosing sessions. Follow up period will start 10 days (+-1 day) after the last dose of Session 2. A total number of 36 subjects will be enrolled for the study with 27 subjects receiving a dose strength of GSK2269557 and 9 subjects will receive each dose strength of GSK2269557. ELLIPTA is a trademark of the GSK group of companies.
アジアにおける非小細胞肺癌患者を対象としたPD-L1研究
MEDI-APEX is a non-interventional, retrospective, cohort study to characterize PD-L1 expression and to assess the clinical characteristics and outcomes among NSCLC patients
ALK、ROS1、またはNTRK1-3遺伝子変異を有する進行固形腫瘍患者におけるレポトレクチニブ（TPX-0005）の研究
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.