治験一覧
8,963 件中 3861〜3880 件を表示
日本、韓国、台湾のRA患者に対するアダリムマブ追加療法としてのMTX最適用量の評価
This study will be conducted in Japan, South Korea and Taiwan to evaluate the optimal dosage of methotrexate (MTX) as an add-on therapy to adalimumab (ADA) in participants with rheumatoid arthritis (RA) who have not achieved remission by MTX monotherapy.
子宮内膜がんにおけるアテゾリズマブ試験 - AtTEnd
Atezolizumab is an engineered humanised monoclonal immunoglobulin G1 antibody that binds selectively to PD-L1 and prevents its interaction with PD-1 and B7-1. In May 2016 atezolizumab was approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant); in October 2016 it was approved by the FDA for patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. Finally, in April 2017 atezolizumab was granted accelerated approval by FDA for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. Combinations of atezolizumab with chemotherapeutic agents and/or targeted therapies were studied in different solid tumors such as melanoma, NSCLC, renal cell carcinoma and colorectal carcinoma. From these studies the AE profile of atezolizumab combinations were consistent with that of the individual agents. Finally, preliminary results of a Phase Ia study of Atezolizumab (NCT01375842) monotherapy in relapsed endometrial cancer were reported as abstract at ASCO 2017. Fifteen patients were evaluated for safety and efficacy with a minimum follow-up of 11.2 months. No G4-5 related AEs occurred. Regarding efficacy ORR was 13% \[2/15\] by RECIST. Atezolizumab seemed to have a favorable safety profile, with durable clinical benefit in some patients. Further studies with atezolizumab are warranted given its promising results in advanced endometrial cancer and the limited efficacy of current treatment options.
既治療CLL/SLLまたはNHL患者における経口LOXO-305の試験
This is an open-label, multi-center Phase 1/2 study of oral LOXO-305 (pirtobrutinib) in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.
特定の再発性または難治性血液悪性腫瘍患者におけるAMG 397の安全性、忍容性、薬物動態および有効性
Evaluate the safety and tolerability of AMG 397. Estimate the maximum tolerated doses (MTDs) and/or biologically active doses.
低侵襲冠動脈手術と胸骨切開による冠動脈バイパス移植術の比較試験
MICS CABG (Minimally invasive coronary surgery), where coronary artery bypass grafting (CABG) is completed through a small incision over the left chest, has evolved to become a safe and less invasive alternative to conventional sternotomy CABG. Several observational studies have suggested significantly shorter time to return to physical activity for MICS CABG patients compared to sternotomy CABG patients. A randomized study is warranted to validate these findings, provide higher level of evidence, and potentially lead to changes in practice. The MIST Trial is a multi-centre, prospective, open label, randomized control trial comparing quality of life and recovery in the early post-operative period, between patients undergoing MICS CABG versus patients undergoing sternotomy CABG. Patients referred for isolated CABG for multi-vessel coronary artery disease and deemed technically suitable for sternotomy CABG as well as for MICS CABG are considered for enrollment into the trial. Quality of life questionnaires (The SF-36, Seattle Angina Questionnaire and EQ-5D-5L) will be used to assess the quality of life and recovery in patients undergoing sternotomy CABG or MICS CABG at 1 month, 3 months, 6 months and 12 months follow up.
中等度から重度のアトピー性皮膚炎を有する青年および成人患者を対象に、ウパダシチニブと局所コルチコステロイドの併用を評価する試験
The objective of this study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
妊娠11～13週における妊娠高血圧症候群（PE）の予測
This is an international multicentre prospective cohort study to validate the Bayes theorem based algorithms for the screening of pre-eclampsia (PE) in the first-trimester of pregnancy.
小児非ホジキンリンパ腫患者におけるティサゲンレクルセルの安全性および有効性を評価するための第II相非盲検試験
The purpose of the study was to assess the efficacy and safety of tisagenlecleucel in pediatric, adolescent and young adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) including Burkitt Lymphoma and Burkitt Leukemia. For pediatric patients who have r/r B-NHL including Burkitt Lymphoma and Burkitt Leukemia, survival rates are dismal, only \~20-50% subjects are alive at 2 years with overall response rate (ORR) of 20-30% after conventional salvage chemotherapy.
短腸症候群の日本人被験者におけるテデュグルチドの研究
The objectives of this clinical study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of teduglutide in Japanese participants with short bowel syndrome (SBS) who are dependent on parenteral nutrition/intravenous (PN/IV) over a 24-week treatment period.
転移性乳がんに対するS 81694とパクリタキセルの併用療法
The purpose of this study is to determine the safety profile, the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with paclitaxel in metastatic breast cancer (mBC) patients, and to investigate the antitumour activity of the combination in metastatic triple negative breast cancer (mTNBC) patients.
近赤外分光法血管内超音波検査による、アリロクマブ（プロタンパク質変換酵素サブチリシン/ケキシン9型阻害剤）とロスバスタチンの併用、またはロスバスタチン単独投与が冠動脈疾患における脂質コアプラークに及ぼす影響
The purpose of this study is to verify whether additional administration of Alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone administration in patients receiving PCI. Therefore, the change in maxLCBI (4 mm) of the coronary artery 9 months after administration by addition administration of Alirocumab is evaluated as the main evaluation item as compared with statin administration alone for patients who have CAD and received PCI. Also, change of plaque properties is compared with baseline and evaluated. This study is a single-center, randomized, open-label study, using alirocumab, rosuvastatin as test drugs. Based on the findings obtained in this study, it is possible to clarify the mechanism of stabilization of the plaque in a patient with coronary artery disease, which in turn suppresses the progress of plaque in coronary artery disease, resulting in primary or secondary There is a possibility that it can contribute to prevention.
健康なボランティアおよびナルコレプシー患者におけるTAK-925の安全性、忍容性、薬物動態および薬力学を評価するための研究
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants.
血友病A患者における第VIII因子製剤トゥロクトコグアルファペゴル（N8-GP）の作用機序を調べた研究
This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participants will get an injection of N8-GP into a blood vessel, one, two or three times weekly. Participants will get more doses if they bleed or if they will need a surgery. The study will last for about 2 years. Participants will have at least 9 visits with the study doctor. If participants agree to be in this study, they will get their first injection (in this study) at the first visit. Participants will also get an injection at visit 3, 5 and 7. Participants will be trained to give all other injections themselves. Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood thinners) during the study.
血液透析患者における循環P3NPと心血管イベント
This study evaluates whether circulating levels of aminoterminal propeptide of type III procollagen (PIIINP) can predict the cardiovascular events in hemodialysis patients.
C型またはB型肝炎ウイルス由来肝硬変に対するPRI-724の安全性と有効性
To investigate the safety and efficacy of PRI-724 against HCV or HBV liver cirrhosis.
中等度から重度のアトピー性皮膚炎を有する青年および成人患者における、ウパダシチニブと局所コルチコステロイドの併用療法の安全性を評価する研究
The objective of this study is to assess the safety of upadacitinib combined with topical corticosteroids (TCS) in adolescent and adult participants in Japan with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
ASP8302の単回および複数回経口投与による用量漸増試験（非高齢の健康な日本人被験者対象）
The objective of this study is to evaluate the safety, tolerability and pharmacokinetic of single/multiple ascending oral doses of ASP8302 in non-elderly healthy Japanese male and female subjects.
初期症状のアルツハイマー病患者を対象としたLY3303560の研究
The purpose of this study is to evaluate the safety and efficacy of a study drug that targets an abnormal protein in the brain found in people with Alzheimer's Disease (AD).
CKD患者におけるバルドキソロンメチルの拡張アクセスプログラム（EAGLE）
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner.
再発性または難治性多発性骨髄腫患者を対象とした、B細胞成熟抗原（BCMA）を標的としたキメラ抗原受容体T細胞（CAR-T）療法であるJNJ-68284528の研究
The purpose of the study is to characterize safety of JNJ-68284528 and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of JNJ-68284528 (Phase 2).