治験一覧
8,963 件中 3901〜3920 件を表示
グレードII-IVの急性移植片対宿主病の小児患者におけるルキソリチニブの薬物動態、活性および安全性の研究
The study was an open-label, single-arm, Phase I/II multi-center study to investigate the PK, activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in infants, children, and adolescents ages ≥28 days to \<18 years old with either grade II-IV aGvHD or grade II-IV SR-aGvHD. The trial design included four age groups: Group 1 included patients ≥12y to \<18y, Group 2 included patients ≥6y to \<12y, Group 3 included patients ≥2y to \<6y, and Group 4 included patients ≥28days to \<2y.
原発不明癌患者における標的療法または癌免疫療法とプラチナ製剤ベースの化学療法の有効性と安全性を比較する第II相ランダム化試験
This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy.
切除可能なステージII、IIIA、および切除可能なステージIIIB（T3-4N2）非小細胞肺癌患者を対象とした、プラチナ製剤併用化学療法とペムブロリズマブ（MK-3475）の併用療法の有効性および安全性（MK-3475-671/KEYNOTE-671）
This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery \[neoadjuvant phase\], followed by pembrolizumab alone after surgery \[adjuvant phase\] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).
原因不明の活動性若年性関節炎を有する日本人小児および青年におけるオレンシアの安全性に関する研究
Observational study of abatacept in the treatment of JIA in Japan.
固形腫瘍患者を対象としたMORAb-202（以下、ファルレツズマブ・エクテリブリンと呼ぶ）の臨床試験
The primary objective of this study is to evaluate the tolerability and safety profile of farletuzumab ecteribulin in participants with solid tumors.
アジルサルタン（TAK-536）小児用製剤の第1相食事影響試験
The purpose of this study is to assess the PK of TAK-536 and effect of food on the PK following single oral administration of TAK-536 pediatric formulation in Japanese healthy adult male participants.
心不全および収縮機能障害を有する患者におけるHNO（ニトロキシル）供与体の持続注入に関する研究
The purpose of this study is to evaluate the effects of BMS-986231 on systolic and diastolic parameters in patients with heart failure and low ejection fraction.
IQOSの実生活における受動的曝露評価
This study is a non-interventional observational study designed to assess the impact of passive exposure to IQOS environmental tobacco aerosol in Non-Smokers in a real-life restaurant setting.
逆流性食道炎、胃潰瘍または十二指腸潰瘍を有する日本人小児患者におけるエソメプラゾール（D961H）の研究
This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis. Doses of D961H in this study is set for the 2 groups (weight more than equal 10 kg to less than 20 kg and weight more than equal 20 kg) in the maintenance therapy for healed reflux esophagitis group and the prevention of gastric ulcer or duodenal ulcer recurrence by non-steroidal anti-inflammatory drugs or low-dose aspirin therapy group, Primary endpoints are evaluated at week 32. Further, this study is designed to evaluate the long term efficacy and safety of D961H for a maximum of 52 weeks, in consideration of the medical needs for long term proton pump inhibitor treatment. Patient can continue study treatment up to 52 weeks, if they want
SMN2遺伝子多コピーを有する脊髄性筋萎縮症（SMA）患者における静脈内オナセムノゲンアベパルボベック-xioiの発症前研究
To evaluate the safety and efficacy of intravenous onasemnogene abeparvovec-xioi in pre-symptomatic patients with SMA and 2 or 3 copies SMN2
健康な日本人男性被験者におけるJNJ-64565111の皮下注射の安全性、忍容性および薬物動態を評価する研究、ならびに健康な白人男性被験者におけるJNJ-64565111の皮下注射後の薬物動態を評価する研究
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-64565111 following single and multiple subcutaneous (SC) doses in healthy Japanese male participants.
非筋層浸潤性膀胱癌におけるBCG併用療法と標準治療（BCG）との比較によるデュルバルマブ＋BCGの有効性と安全性の評価
This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer
複雑性皮膚軟部組織感染症（cSSTI）および菌血症を有する日本人小児患者におけるダプトマイシン（MK-3009）の安全性、有効性、および薬物動態（PK）（MK-3009-029）
The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK) parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years with complicated skin and soft tissue infection (cSSTI) or bacteremia caused by gram-positive cocci.
JUNIPER：特発性肺線維症患者におけるND-L02-s0201の安全性、生物学的活性、および薬物動態を評価する第2相試験
A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.
急性大血管閉塞症（広範囲の虚血性病変を伴う）に対する血管内治療の無作為化比較試験
RESCUE-Japan LIMIT(Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism Japan Large IscheMIc core Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to compare the effectiveness of endovascular treatment as compared to best medical treatment alone in the acute ischemic stroke patients with an low ASPECTS (CT-ASPECTS 3-5 or DWI-ASPECTS 3-5). The purpose of this study is to investigate the efficacy of endovascular treatment for acute large vessel occlusion with large ischemic core (CT-ASPECT score 3-5 or DWI-ASPECT score 3-5).
ITP患者におけるエルトロンボパグによる治療中止後の持続的反応誘発能力を評価する研究
The purpose of this trial was to assess the ability of eltrombopag to induce sustained treatment-free remission in immune thrombocytopenia purpura (ITP) subjects who relapsed or failed to respond to an initial treatment with steroids.
非乳がんHER2陽性進行がんにおけるNJH395の安全性と投与量を決定するための研究
A first-in-human study using NJH395 in non-breast HER2-positive advanced malignancies
ZOSTER-006およびZOSTER-022試験中の被験者の虚弱度を評価する研究
As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study participants completed quality of life (QoL) questionnaires. The only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study. The purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.
糖尿病性腎症患者におけるバルドキソロンメチルの第3相臨床試験；AYAME試験
The purpose of this study is to demonstrate the efficacy of multiple oral doses of RTA 402 (5, 10, or 15 mg) administered once daily in patients with diabetic kidney disease (DKD) using the time to onset of a ≥ 30% decrease in estimated glomerular filtration rate calculated from serum creatinine (eGFR) from baseline or end-stage renal disease (ESRD) as an indicator in a randomized, double-blind, placebo-controlled study; the safety of RTA 402 will also be evaluated.
成人血友病B患者における現行のFIX補充療法（FIX:C≤2%）または成人血友病A患者における現行のFVIII補充療法（FVIII:C≤1%）の有効性および安全性データの前向き評価研究
To establish baseline prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study. To establish baseline prospective efficacy data of current FVIII prophylaxis replacement therapy in the usual care setting of hemophilia A subjects, who are negative for nAb to AAV6, prior to the Phase 3 gene therapy study. The enrollment for hemophilia A participants is completed. At this time participants are only being enrolled for hemophilia B cohort.