治験一覧
8,963 件中 2561〜2580 件を表示
ONO-7913第I相臨床試験（ONO-7913）
To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.
KRAS G12C変異を有する患者を対象としたアダグラシブ単独療法およびペムブロリズマブとの併用療法の第2相試験、ならびにアダグラシブ併用療法の第3相試験 KRYSTAL-7
The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.
新たに診断された進行卵巣がん患者における組織BRCA1/2変異の有病率を調査するための横断的アプローチの特徴付け
This is a multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially. In this study, data of 200 subjects will be collected at approximately 20 sites in Japan. To reduce regional bias of study sites, the number of enrolled patients per site will be capped
SARS-CoV-2感染による重症肺炎患者におけるADR-001の探索的研究
Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.
進行性/転移性胃食道腺癌患者におけるレンバチニブ（E7080/MK-7902）+ペムブロリズマブ（MK-3475）+化学療法の有効性と安全性（MK-7902-015/E7080-G000-321/LEAP-015）
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer. The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.
慢性または反復性片頭痛患者を対象とした、片頭痛予防のための経口アトゲパントの効果を評価する研究
This study will evaluate the long-term safety, efficacy and tolerability of atogepant 60 mg daily for the prevention of migraine in Japanese participants with chronic (CM) or episodic migraine (EM).
IgA腎症に対するADR-001の臨床試験
The purpose of this study is to evaluate the safety and the tolerability of ADR-001 in Immunoglobulin A (IgA) Nephropathy patients. In addition, the investigators will evaluate the efficacy of ADR-001 for IgA Nephropathy patients.
眼底の異常血管の増殖により視力喪失を引き起こす加齢性疾患患者に高用量アフリベルセプトを眼内に注入した場合の効果に関する研究
In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.
急性虚血性脳卒中患者における同種ヒト歯髄幹細胞JTR-161の有効性および安全性を評価するための無作為化プラセボ対照多施設共同試験（J-REPAIR）
The objective of this study is to evaluate the safety and efficacy of a single intravenous administration of JTR-161 (allogeneic stem cell product derived from the dental pulp of healthy adult humans) to patients with acute ischemic stroke. This study is comprised of 3 cohorts and conducted in the order of Cohort 1, Cohort 2 and Cohort 3. Cohort 1 Arm-1: JTR-161, 1 × 10\^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects The Data and Safety Monitoring Board (DSMB) and the Sponsor will decide whether Cohort 2 can be initiated or not. Cohort 2 Arm-1: JTR-161, 3 × 10\^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects DSMB and the Sponsor will decide whether Cohort 3 can be initiated or not and the dose of JTR-161 in Cohort 3. Cohort 3 Arm-1: JTR-161, 1 × 10\^8 cells/subject or 3 × 10\^8 cells/subject, 30 subjects Arm-2: Placebo, 30 subjects
HFNCを用いた様々なFiO2および酸素流量における運動能力
The purpose of this study is to compare the exercise capacity (6-min walking distance) under the following 4 conditions using High-flow nasal cannula (HFNC); 1. FIO2 value that the minimum SpO2 value in a 6-minute walking test (6MWT) is 86-88%, and a flow of 10 L/min 2. FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min 3. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min 4. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min
重症難治性喘息患者におけるCSJ117の有効性および安全性に関する研究
The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.
持続性/慢性原発性免疫血小板減少症の成人患者におけるTAK-079の試験
Primary immune thrombocytopenia (ITP) is a rare disease that results in low levels of platelets - the cells that help blood clot. The main aim of the study is to check for side effects from taking TAK-079 at three different dose levels. Another aim is to learn if TAK-079 can increase the platelet count in people with ITP. In addition to receiving stable background therapy for ITP, participants will receive an injection of either TAK-079 or a placebo once a week for 2 months. A placebo looks like TAK-079 but will not have any medicine in it. After treatment, all participants will be followed-up for another 2 months. Then, participants who received TAK-079 will continue to be followed-up for an extra 4 months. Participants who received the placebo and would like to receive TAK-079 may be able to do this in an extension period in the study.
トレラグリプチン錠の特定薬剤使用調査「重度の腎機能障害または末期腎不全を伴う2型糖尿病患者における長期使用に関する調査」
The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.
片頭痛のある6～17歳の小児を対象としたラスミディタン（LY573144）治療の12ヶ月間試験
The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.
中等度から重度の活動性潰瘍性大腸炎（UC）の小児患者を対象としたウステキヌマブの研究
The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active UC.
発作性心房細動に対するStablePointカテーテルおよび力覚センシングシステムの臨床評価
The NEwTON AF study is a multi-center, global, prospective, single arm study to establish the safety and effectiveness of the IntellaNav StablePoint Catheter and Force-Sensing System in subjects with symptomatic, drug refractory, recurrent paroxysmal atrial fibrillation.
AHEAD 3-45試験：前臨床アルツハイマー病およびアミロイドーシス高値の参加者と、早期前臨床アルツハイマー病および中等度のアミロイドーシス参加者におけるレカネマブ治療の有効性と安全性を評価する試験
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase.
日本人成人におけるVAC52416（ExPEC10V）の異なる投与量を評価する研究
The purpose of this study is to evaluate the safety and reactogenicity of different doses of extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years of age.
難治性てんかん患者におけるミトコンドリア病治療薬バチキノンの有効性および安全性を評価する研究
This is a parallel-arm, double-blind, placebo-controlled study with a screening phase that includes a 28-day run-in phase to establish baseline seizure frequency, followed by a 24-week, randomized, placebo-controlled phase. After completion of the randomized, placebo-controlled phase, participants may enter a 48-week, long-term, extension phase during which they will receive open-label treatment with vatiquinone.
60歳以上の日本人成人を対象とした、高用量4価インフルエンザワクチン（QIV-HD）と標準用量4価インフルエンザワクチン（QIV-SD）の免疫応答および安全性プロファイルを比較する研究
Primary Objective: To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition \[HAI\] geometric mean titers \[GMTs\] and seroconversion rates) that was superior to responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all participants. Secondary Objective: * To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method in all participants. * To describe the safety profile of all participants in each study group.