治験一覧
8,963 件中 4101〜4120 件を表示
抗凝固薬を服用している患者に対するヘパリンブリッジなしのEUS-FNA
To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin bridge.
標準治療による喘息コントロールが不十分な喘息患者におけるQAW039の安全性に関する研究
This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma. The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients: 1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and 2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039. By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.
TAK-536小児用製剤の第1相生物学的同等性試験
The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in Japanese healthy adult male participants in an open label, 2-period, 2-treatment, cross-over design.
胃がん患者を対象とした、リボセラニブと最良支持療法の併用療法とプラセボと最良支持療法の併用療法を比較評価する研究
The purpose of this study is to evaluate the efficacy and safety of rivoceranib plus best supportive care (BSC) compared to placebo plus BSC in participants with advanced or metastatic gastric cancer (GC).
ダブラフェニブおよび/またはトラメチニブのロールオーバー試験
この研究は、ノバルティスがスポンサーとなっているオンコロジーグローバル開発、グローバルメディカルアフェアーズ、または以前GSKがスポンサーとなった研究でダブラフェニブおよび/またはトラメチニブによる治療を受けており、主要目的の要件を満たし、親研究の完了時に治験責任医師によって親研究での継続治療から利益を得ていると判断された患者にアクセスを提供することを目的としています。
既治療の固形腫瘍および血液悪性腫瘍患者におけるABBV-621の安全性および忍容性に関する研究
This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously-treated solid tumors or hematologic malignancies. Only chemotherapy combination (ABBV-621 + FOLFIRI) enrolling participants with RAS-mutant CRC who have received one prior line of therapy is open for enrollment.
滑膜肉腫患者におけるTBI-1301（NY-ESO-1 T細胞受容体遺伝子導入自己Tリンパ球）の研究
The purpose of this study is to evaluate the safety and the efficacy of TBI-1301 for NY-ESO-1 expressing synovial sarcoma when administered following cyclophosphamide pre-treatment.
遺伝子型1～6の慢性C型肝炎ウイルス（HCV）感染症の小児患者におけるグレカプレビル/ピブレンタスビルの薬物動態、安全性、および有効性を評価する研究
The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in children ages 3 to \< 12 years.
部分発作（二次性全般発作の有無を問わず）または原発性全般強直間代発作を有する青年期てんかん患者におけるフィコンパ錠の長期投与の臨床的安全性および有効性の調査
The objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa: 1. unknown adverse drug reactions (ADRs); 2. occurrence of ADRs; 3. factors that are likely to affect safety and efficacy; 4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items; 5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).
転移性膵腺癌の成人患者におけるナパブカシン、ナブパクリタキセル、ゲムシタビンの併用療法に関する研究
This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma.
心不全で入院中の患者におけるHNO（ニトロキシル）供与体の48時間点滴投与の安全性と有効性を評価する
A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function
進行期小細胞肺癌患者を対象とした、ペムブロリズマブ（MK-3475）とエトポシド／プラチナ製剤（シスプラチンまたはカルボプラチン）の併用療法に関する研究（MK-3475-604/KEYNOTE-604）
The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum \[EP\]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy. The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC. In this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. With protocol Amendment 07 (03-Oct-2018), the outcome measure of "Change from Baseline at Weeks 12 and 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale" was replaced with a single time point analysis at Week 18.
日本のプラダクサPMS、長期
The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab
切除不能または転移性黒色腫を有する日本人患者におけるTBI-1401(HF10)とイピリムマブの併用療法に関する研究
The purpose of this study is to determine if TBI-1401(HF10) in combination with ipilimumab is effective in Japanese patients with stages IIIB, IIIC, or IV unresectable or metastatic melanoma.
多施設国際横断的肺胞蛋白症評価試験
The purpose of this study is to (1) compare a technically improved assay with an existing assay used to measure serum anti-GM-CSF antibodies in stored serum samples previously obtained from patients diagnosed with either primary, secondary, congenital or idiopathic pulmonary alveolar proteinosis (PAP), other chronic diseases or disease-free, healthy individuals; (2) determine the prevalence and levels of anti-GM-CSF autoantibodies and (3) define the breadth of the autoimmune antibody responses in primary PAP patients from the United States, Japan, Australia, and Europe using previously collected serum samples; and (4) using a chart review approach, compare the clinical, radiologic and laboratory features of primary PAP patients to determine if differences exist among patients in these globally geographically distributed regions.
複雑性腹腔内感染症または複雑性尿路感染症を有する日本人被験者におけるイミペネム＋シラスタチン／レレバクタム（MK-7655A）の有効性および安全性（MK-7655A-017）
The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (IMI/REL, MK-7655A) in Japanese participants with complicated intra-abdominal infection (cIAI) or complicated urinary tract infection (cUTI).
仙骨脊索腫：原発性局所性疾患における手術と根治的放射線療法
Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma
デュシェンヌ型筋ジストロフィーにおけるアタレンの長期転帰
This study is a long-term study of ataluren in participants with nonsense mutation Duchenne muscular dystrophy.
進行膵臓がん患者における、化学療法併用または非併用でのニボルマブとカビラリズマブの併用投与に関する研究
The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.
切除不能肝細胞癌（uHCC）と診断された患者におけるレゴラフェニブの安全性と有効性を、実際の臨床現場条件下で評価する観察研究
Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)