治験一覧
8,963 件中 3741〜3760 件を表示
日本人におけるステロイド未治療の急性移植片対宿主病の治療におけるイタシチニブとコルチコステロイドの併用療法の安全性
The purpose of this study is to assess the safety and tolerability of itacitinib in combination with corticosteroids in Japanese subjects with Grades II to IV acute graft-versus-host disease (aGVHD).
赤血球輸血を必要とし、ESA未治療のIPSS-R超低リスク、低リスク、または中リスクの骨髄異形成症候群（MDS）患者における貧血の治療におけるルスパテルセプト（ACE-536）とエポエチンアルファの有効性および安全性を比較する研究
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).
駆出率保持型心不全患者の生活の質を改善するためのダパグリフロジンの評価。
This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.
6歳から17歳までの反復性片頭痛患者を対象としたガルカネズマブ（LY2951742）の試験
The main purpose of this study is to evaulate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
発作性夜間ヘモグロビン尿症（PNH）患者におけるAPL-2の有効性および安全性を評価するための研究
Evaluation of the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria
慢性咳嗽を有する成人被験者を対象としたゲファピキサント（MK-7264）の研究（MK-7264-027）
The main objectives of this study will be to evaluate the efficacy of gefapixant in reducing cough frequency as measured over a 24-hour period at Week 12, and to evaluate the safety and tolerability of gefapixant. The primary hypothesis is that at least one gefapixant dose is superior to placebo in reducing coughs per hour (over 24 hours) at Week 12.
ISTODAX®静脈内投与薬使用結果調査 - 再発性または難治性末梢性T細胞リンパ腫
To ascertain the safety and efficacy of Istodax® in actual clinical settings in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who receive Istodax. 1. Planned registration period 4 years 2. Planned surveillance period 5 years and 6 months
ペグセタコプランの長期安全性および有効性延長試験
This is an Open-label, Non-Randomized, Multi-Center Extension Study. Eligible subjects will have previously completed a pegcetacoplan study.
レゴラフェニブとニボルマブの同時併用療法
the efficacy and safety ofhe use of regorafenib in combination with nivolumab
潰瘍性大腸炎患者におけるリサンキズマブの有効性と安全性を評価する試験
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.
骨接合術および骨切り術における3D術前計画のための画像融合システム
Utility of image fusion system for the fracture and fracture malunion management will be evaluated.
中等度から重度の活動性潰瘍性大腸炎患者を対象とした、リサンキズマブの有効性および安全性を評価するための多施設共同、無作為化、二重盲検、プラセボ対照導入試験
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
骨髄異形成症候群患者におけるSyB C-1101の研究
To assess tolerability of SyB C-1101 when administered orally BID for 21 days followed by a 7-day observation period in patients with recurrent/relapsed or refractory myelodysplastic syndrome in order to determine a recommended dose (RD). To assess safety, efficacy and pharmacokinetics.
進行性または転移性固形腫瘍患者を対象とした、ONO-7475とONO-4538の併用療法および非併用療法に関する第1相臨床試験
To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors
高トリグリセリド血症患者におけるMND-2119の有効性
The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.
ヒト上皮成長因子受容体2（HER2）発現または変異非小細胞肺がんにおけるDS-8201a
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.
挿入型心臓モニターSMARTレジストリの処方箋確認
The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.
Lu AA21004 20 mg錠と2×10 mg錠の生物学的同等性試験
The purpose of this study is to evaluate the bioequivalence of a single oral administration of a vortioxetine (Lu AA21004) 20 mg tablet in comparison with two of vortioxetine 10 mg tablets in Japanese healthy adult participants.
関節リウマチ患者におけるバリシチニブの有効性および安全性の検討
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients: 1. Baricitinib treatment for 12 months 2. Biologics treatment for 12 months 3. Tofacitinib treatment for 12 months
パーキンソン病の日本人被験者におけるBIIB054の安全性、忍容性、薬物動態および薬力学を評価する研究
The primary objective of this study is to evaluate the safety and tolerability of a range of single and 13 repeated doses of BIIB054, administered as intravenous (IV) infusion, in Japanese participants with Parkinson's disease (PD). The secondary objectives are to evaluate the immunogenicity, and serum pharmacokinetics (PK) profile of BIIB054 after single and multiple dose administration.