治験一覧
8,963 件中 4001〜4020 件を表示
65歳以上の患者における高用量4価インフルエンザワクチンの安全性および免疫原性
This phase I/II, randomized, modified double-blind, multi-center study assessed the safety and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults (greater than or equal to \[\>=\] 65 years).
日本人の健康な高齢男性を対象としたダニリキシンに関する研究
Danirixin is a selective chemokine receptor antagonist being developed as a potential anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD). The aim of the study is to assess the safety, tolerability and pharmacokinetics (PK) in healthy Japanese subjects over the age of 65 years (inclusive). The study will be conducted in two parts: Part 1 will be a double blind, placebo-controlled, 3-period crossover, ascending single oral dose administration of GSK1325756H (Hydrobromide Salt Tablet Formulations of Danirixin) 10, 50 and 100 milligram (mg) in the fed condition. Part 2 will be an open label, 2-period crossover, single oral dose of GSK1325756H 50 mg in fed and fasted state. This study will provide an understanding of PK of hydrobromide salt of GSK1325756 in population of healthy elderly subjects and also contribute to the selection of appropriate dosing for Phase IIa study in Japan.
転移性膵臓がん、転移性結腸直腸がん、およびその他の進行性固形腫瘍患者におけるTAK-931の安全性、忍容性、および有効性を評価するための研究
The purpose of this study is to confirm the safety and tolerability of TAK-931 in a cohort of Western participants with metastatic solid tumors and to evaluate the anti-tumor activity of TAK-931 in participants with metastatic pancreatic cancer, colorectal cancer (CRC), squamous esophageal cancer (sqEC), and squamous non-small-cell lung cancer (sqNSCLC).
てんかん患者（16歳以上80歳未満）を対象としたブリバラセタムの有効性と安全性を評価する研究
The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (\>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects \>= 16 years to 80 years of age.
ムコ多糖症II型患者におけるJR-141の研究
The purpose of this study in patients with mucopolysaccharidosis type II (MPS II) is below, * to collect the safety information of JR-141 * to evaluate the plasma pharmacokinetics of JR-141 * to explore the efficacy of JR-141 on MPS II-related central nervous system symptoms and general symptoms
進行固形腫瘍を有する成人患者におけるTNO155の用量設定試験
The purpose of this first in human (FIH) trial was to characterize the safety and tolerability of the SHP2 inhibitor TNO155 alone and in combination with EGF816 (nazartinib) and identify a recommended dose for future studies in adult patients with advanced solid tumors in selected indications.
ANCA関連血管炎患者を対象としたCCX168（アバコパン）の第3相臨床試験
The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab.
最近の輸血歴のない原発性寒冷凝集素症患者におけるBIVV009（スチムリマブ）の有効性および安全性を評価する研究
The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (\>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.
X連鎖性低リン血症性くる病/骨軟化症の小児患者におけるKRN23の研究
Before switching to the post-marketing study: To evaluate the efficacy and safety of KRN23 administered subcutaneously once every 2 weeks in children with X-linked hypophosphatemic rickets/osteomalacia(XLH). After switching to the post-marketing study: To evaluate the safety and efficacy of KRN23, which is switched from the investigational product to the post-marketing study drug, at the approved dose and dosing regimen in subjects who continue treatment
痛風の有無にかかわらず高尿酸血症におけるFYU-981の研究
The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.
急性リンパ性白血病における第IIIB相臨床試験
This is a single arm, open-label, multi-center, phase III B study to determine the safety and efficacy of CTL019 in pediatric/young adult patients with r/r B-cell Acute Lymphoblastic Leukemia (ALL).
駆出率が保たれた慢性心不全患者を対象とした、ネラデノソン・ビアラン酸塩の20週間にわたる臨床試験
The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities.
プラズマロゲンが肥満被験者に及ぼす影響
This is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of scallop-derived plasmalogen on brain fatigue, body weight and changes in blood plasmalogen in obese subjects aged 20-75 years old.
急性虚血性脳卒中におけるMCI-186の用量設定試験
To investigate the efficacy and safety of MCI-186 (bolus followed by continuous infusion) in acute ischemic stroke patients through a double-blind, parallel-group comparison with the existing MCI-186 dosing regimen (administration twice daily for 14 days) as the control.
高リスクくすぶり型多発性骨髄腫患者におけるダラツムマブ皮下投与と積極的モニタリングの比較試験
The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).
新規診断全身性アミロイド軽鎖（AL）アミロイドーシスにおけるダラツムマブとシクロホスファミド、ボルテゾミブ、デキサメタゾン（CyBorD）の併用療法とCyBorD単独療法の有効性と安全性を評価する研究
The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
RELVAR® 100 ELLIPTA® 特別薬剤使用調査（COPD、長期）
This study aims to investigate the long-term safety and efficacy of RELVAR® 100 ELLIPTA® (hereinafter referred to as "Relvar") in daily clinical practice in subjects with chronic obstructive pulmonary disease (COPD), who are naive to RELVAR. A total of 1000 subjects, from approximately 200 medical institutions, will be registered for this study and 332 of them will be considered for safety analysis. In the investigation, subject registration and data collection will be conducted using an Electronic Data Capture (EDC) system. Post-registration, the investigator will monitor the information regarding the safety and efficacy of RELVAR for one year from the start date of treatment with RELVAR. Pneumonia, systemic effects caused by corticosteroids and cardiovascular events will be considered as the priority investigation matters. At the end of observation period, the investigator will enter the obtained information into the EDC system and submit it. RELVAR 100 ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.
入院中の呼吸器合胞体ウイルスに感染した生後28日から36ヶ月の乳幼児および小児における経口投与ルミシタビン（JNJ-64041575）投与レジメンの抗ウイルス活性、臨床転帰、安全性、忍容性、および薬物動態を評価する研究
The purpose of this study is to determine in hospitalized infants and children who are infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase polymerase chain reaction (qRT-PCR).
軸性脊椎関節炎患者を対象としたイキセキズマブ（LY2439821）の長期延長試験
The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.
再発性または難治性多発性骨髄腫患者におけるAMG 701単独療法、またはポマリドミドとの併用療法（デキサメタゾンの有無にかかわらず）を評価する試験
The primary purpose of the phase 1 part of the study is to evaluate safety and tolerability of AMG 701 monotherapy to identify the RP2D for AMG 701 monotherapy followed by a dose-confirmation part to gather further safety data for AMG 701 monotherapy at the RP2D in adult subjects with relapsed/refractory multiple myeloma (RRMM). In addition, this study will include a sequential dose exploration part to identify the RP2D of AMG 701 in combination with pomalidomide, with and without dexamethasone (AMG 701-P+/-d). Phase 2 will consist of the dose-expansion part to gain further efficacy and safety experience with AMG 701 monotherapy in adult subjects with RRMM.