治験一覧
8,963 件中 4121〜4140 件を表示
未治療MCL患者におけるBR単独とアカラブルチニブとの併用を比較する試験
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
将来的なパイロット研究（BIO|SELECTパイロット研究）
Enrolled patients implanted with Biotronik CRT-D and QP lead equipped with MultiPole pacing mode is grouped into which programmed into MultiPole pacing, or conventional bi-ventricular pacing mode. They are followed up by seven month post implantation, and predefined cardiac functional parameters are collected at each visit.
新たに慢性期慢性骨髄性白血病と診断された日本人成人患者におけるボスティニブの研究
Phase 2, single-arm, open-label trial. Patients will receive bosutinib for the duration of the study.
胃癌または胃食道接合部（GEJ）腺癌患者を対象とした、ペンブロリズマブ（MK-3475）と化学療法の併用とプラセボと化学療法の併用を比較する試験（MK-3475-585/KEYNOTE-585）
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary study hypotheses are that: * Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and * Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery. With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.
強皮症関連肺線維症患者におけるニンテダニブの長期投与の安全性を評価する臨床試験
The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
びまん性大細胞型B細胞リンパ腫患者におけるポラツズマブベドチンとリツキシマブ・シクロホスファミド・ドキソルビシン・プレドニゾン（R-CHP）の有効性と安全性を、リツキシマブ・シクロホスファミド・ドキソルビシン・ビンクリスチン・プレドニゾン（R-CHOP）と比較した試験
This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).
進行性／転移性固形腫瘍またはリンパ腫患者におけるMIW815とPDR001の併用療法の安全性および有効性に関する研究
The purpose of this study was to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) in combination with PDR001.
非アルコール性脂肪性肝炎（NASH）による代償性肝硬変を有する成人におけるセロンセルチブの安全性および有効性
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.
国際BPA登録簿
The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).
ZS（ナトリウムジルコニウムシクロケイ酸塩）が透析患者における血中カリウム濃度上昇の発生率を低下させることができるかどうかを検証する研究。
The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia in patients on hemodialysis.
社会不安障害に対する慈悲の瞑想の予備研究
The purpose of this study is to develop and test a mindfulness and loving-kindness based intervention, Positive Affect Training (PAT), to enhance positive affect such as compassion, love, and gratitude and reduce symptoms of social anxiety disorder (SAD). PAT involves a combination of practicing mindfulness meditation and loving kindness meditation in groups. Although PAT has been shown to be effective for dysthymic disorder, one area that remains unclear is whether the PAT protocol for SAD can address the social anxiety symptoms in Japanese adults with SAD. The goal of the research is to test the initial feasibility and efficacy in increasing positive affect and decreasing negative affect in individuals recruited from the general community who are social anxious. If PAT is also effective for Japanese SAD patients, it could be more cost-effective and noninvasive option to address social anxiety disorder.
小児腎疾患におけるFFI-1010の研究
The purpose of this study is revealing that the ratio of creatinine clearance (Ccr) to inulin clearance (Cin) measuring at the same time is more than 1.2.
ADCCを介したB細胞枯渇とBAFF-R阻害
VAY736 dose testing; VAY736 efficacy and safety testing.
慢性B型肝炎患者におけるエンテカビルからテノホビルジソプロキシルフマル酸塩への切り替えに関する研究
Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits Hepatitis B Virus (HBV) growth, and is marketed in Japan with an indication for inhibition of HBV growth in subjects with chronic hepatitis B associated with HBV growth and abnormal liver function. This study has been planned to evaluate the virological effects and safety of switching from ETV to TDF in chronic hepatitis B (hepatitis B e-antigen \[HBeAg\])-positive and HBV- deoxyribonucleic acid (DNA) undetectable subjects. This study is designed as a multi-center, one-arm, post-marketing clinical study to investigate the HBsAg reduction in subjects who have not achieved the long-term goal, the loss of hepatitis B surface antigen (HBsAg). The study will be conducted in HBeAg-positive and HBV-DNA undetectable subjects treated with ETV. After switching ETV to TDF, TDF will be administered for 96 weeks. Approximately 80 subjects will be screened to achieve 65 evaluable subjects.
非透析慢性腎臓病患者における貧血に対するASP1517の間欠的経口投与に関する研究
The objective of this study is to evaluate the efficacy and safety of ASP1517 when converted from recombinant human erythropoietin (rHuEPO) or darbepoetin alfa (DA), compared to DA in the treatment of anemia in non-dialysis chronic kidney disease patients. Another uncontrolled cohort will be included to evaluate the efficacy and safety of ASP1517 in patients converted from epoetin beta pegol (CERA). This study will also assess the safety/efficacy of long term treatment of ASP1517 (52 weeks).
慢性心不全患者におけるダパグリフロジンの心不全悪化または心血管死発生率への影響を評価する研究
The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction
進行性メラノーマにおける抗PD1抗体PDR001とダブラフェニブおよびトラメチニブの併用療法の研究
The purpose of this study was to evaluate safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in patients with BRAF V600 mutant, unresectable and metastatic melanoma.
ENVISION：急性肝性ポルフィリン症（AHP）患者におけるギボシラン（ALN-AS1）の有効性と安全性を評価する研究
The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1), compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic Porphyrias (AHP).
原発性骨髄線維症、真性多血症後骨髄線維症、または本態性血小板血症後骨髄線維症患者を対象としたパクリチニブの第3相試験
This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count \<50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib
輸血歴のある原発性寒冷凝集素症患者を対象としたBIVV009（スチムリマブ）の有効性および安全性を評価する研究（カーディナル試験）
The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (\>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to \>= 12 g/dL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who had 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 CAD.