治験一覧
8,963 件中 2521〜2540 件を表示
新生児低酸素性虚血性脳症に対するCL2020細胞の臨床試験
The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy. In addition, we will evaluate the efficacy of CL2020 cells for infant development.
機能性消化不良の小児患者を対象としたZ-338の第III相臨床試験
The purpose of this study is to evaluate pharmacokinetics, efficacy and safety of Z-338 of pediatric patients with functional dyspepsia (FD). In Part 1, the pharmacokinetics and safety of single oral dose of Z-338 100 mg are evaluated. In Part 2, the efficacy and safety of Z-338 100 mg orally 3 times daily before meals are evaluated. Part 2 is comprised by the double-blind phase and the open-label phase. In the double-blind phase, subjects will take Z-338 or placebo for 28 days. In the open-label phase, all subjects will take Z-338 for 28 days.
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.
KW-6356のQT/QTcに関する研究
The purpose of this study is to evaluate the effects of multiple therapeutic and supratherapeutic doses of KW-6356 on the QT interval corrected for heart rate in Japanese healthy adults.
再発性および/または難治性多発性骨髄腫（RRMM）患者を対象としたイサツキシマブを用いた前向き非介入多国籍観察研究
Primary Objective: To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice To describe safety of isatuximab in routine clinical practice (based on adverse event \[AE\] reporting) To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20) Secondary Objective: Not applicable
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
エスペロクト®の市販後調査（使用成績調査）
The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor. The study will last for about 2 years for each participant.
HER2活性化変異を有する固形腫瘍の治療におけるT-DXdの研究
This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted.
腹圧性尿失禁を有する女性患者を対象としたTAS-303の第2相臨床試験
The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.
未治療の非GCB性DLBCL患者におけるアカラブルチニブとR-CHOPの併用（ACE-LY-312）
Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.
治療抵抗性のマイコバクテリウム・アビウム複合肺疾患（MAC-LD）の成人患者におけるクラリスロマイシンおよびエタンブトールと併用した治療レジメンの一部として投与されたベダキリンの研究
The purpose of the study is to evaluate the efficacy of bedaquiline (BDQ) compared with rifamycin when administered as part of a treatment regimen with clarithromycin (CAM) and ethambutol (EB) in adult participants with treatment-refractory Mycobacterium avium complex-lung disease (MAC-LD) at Week 24 for microbiological assessment in mycobacteria growth indicator tube (MGIT).
未治療の局所進行切除不能または転移性PD-L1選択非小細胞肺癌患者を対象とした、アテゾリズマブとチラゴルマブの併用とアテゾリズマブとプラセボの併用を比較する試験
The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.
1歳以上の健康な日本人を対象とした、ダニ媒介性脳炎（TBE）ワクチンの免疫原性、安全性、および忍容性を評価する研究
The main purpose of this study is to provide safety and immunogenicity data in Japanese participants.
適応型COVID-19治療試験3（ACTT-3）
ACTT-3 will evaluate the combination of interferon beta-1a and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.
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.
NIZ985単独およびスパルタリズマブとの併用による第I/Ib相試験
The purpose of this phase I/Ib study was to determine the safety profile of NIZ985 (new formulation), and if it could be safely combined with spartalizumab or tislelizumab and to determine the appropriate dose and schedule for further study. Moreover, the study characterized the pharmacokinetic profiles of NIZ985 as a single agent and in combination with spartalizumab or tislelizumab and identified preliminary anti-tumor activity.
X連鎖性低リン血症性くる病/骨軟化症の成人および小児患者におけるKRN23の研究
Before switching to the post-marketing study: Assess the efficacy and safety of KRN23 administered subcutaneously once every 4 or 2 weeks in adult or children with XLH After switching to the post-marketing study: To evaluate the safety and efficacy of KRN23, which was switched from the investigational product to the post-marketing investigational product, at the approved dose and dosing regimen in subjects who continued treatment
健康な日本人男性を対象とした、BI 1323495の異なる投与量に対する忍容性と、イトラコナゾールが血中BI 1323495濃度に及ぼす影響を検証する研究
The main objective of the single-rising dose (SRD) part and the multiple rising dose (MD) part is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics (for MD part only) following single rising doses and multiple oral doses of BI 1323495 in healthy male Japanese subjects genotyped as poor metabolizers (PM) and extensive metabolizers (EM) of UGT2B17. The main objective of the drug-drug interaction (DDI) part is to investigate the relative bioavailability of a single oral dose of BI 1323495 when given alone (treatment R) or in combination with itraconazole (treatment T) in healthy male subjects genotyped as PM of UGT2B17.
進行がん患者を対象とした、皮下注射によるラムシルマブ（LY3009806）投与に関する研究
The purpose of this study in participants with advanced cancer is to learn more about the safety of ramucirumab when given by injection under the skin (subcutaneous injection). The study will also measure how much ramucirumab gets into the bloodstream and how long it takes the body to get rid of it.
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