治験一覧
8,963 件中 1901〜1920 件を表示
EGFRmステージIA2-IA3非小細胞肺癌患者における腫瘍完全切除後のオシメルチニブの効果を評価する国際共同研究
This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.
筋萎縮性側索硬化症（ALS）患者におけるPTC857治療の効果を評価する研究
This study will assess the efficacy and safety of PTC857 treatment in participants diagnosed with ALS.
切除不能ステージIII非小細胞肺癌患者における同時化学放射線療法後のデュルバルマブとオレクルマブ、またはデュルバルマブとモナリズマブの併用療法の効果を評価する国際共同研究
This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.
免疫介在性血栓性血小板減少性紫斑病の成人患者における第一選択治療としての血漿交換療法を伴わないカプラシズマブと免疫抑制療法
This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary endpoint of remission in male and female participants aged 18 to 80 years with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The anticipated study duration per participant without a recurrence while on therapy is maximum 24 weeks (ie, approximately 1 day for screening + maximum 12 weeks of treatment for the presenting episode + 12 weeks of follow-up). Participants will have daily assessments during hospitalization and weekly visits for assessments during ongoing treatment with caplacizumab and IST. There will be 3 outpatient visits for assessments during the follow-up period. There will be two additional follow-up visits for participants who do not have ADAMTS13 activity levels of ≥50% at the time of caplacizumab discontinuation.
入院中の心不全悪化患者に対するアンジオテンシン・ネプリライシン阻害薬投与プログラム（PREMIER）
The aim of this study is to assess the treatment effect of sacubitril valsartan versus conventional therapy for heart failure (HF) in admitted patients due to exacerbation of HF on the N-terminal fragment of pro-B-type natriuretic peptide (NT-proBNP) concentrations.
潰瘍性大腸炎（UC）またはクローン病（CD）の小児におけるベドリズマブの研究
The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
糖尿病性腎症患者におけるトホグリフロジンとメトホルミン塩酸塩の尿中アルブミン・クレアチニン比（UACR）への影響の比較（TRUTH-DKD試験）
This multicenter, randomized, open-label, controlled study will assess the efficacy of the SGLT2 inhibitor tofogliflozin on Urine Albumin-to-Creatinine Ratio (UACR) compared to metformin in patients with type 2 diabetes with chronic kidney disease (CKD).
慢性腎臓病と2型糖尿病の患者がどのように治療されているか、またフィネレノンなどの新しい治療選択肢の導入が臨床診療にどのような影響を与えるかについてより詳しく知るための観察研究「FINEGUST」
This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have already started or will start CKD or T2D treatment are collected and studied. In observational studies, only observations are made without specified advice or interventions. People receiving the following CKD or T2D treatments as recommended by their doctors will be included: * Sodium-glucose cotransporter 2 inhibitors (SGLT2i), * Glucagon-like peptide-1 receptor agonists (GLP-1 RA), * Steroidal mineralocorticoid receptor antagonists (sMRA), * Finerenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA) * Other nsMRA (only in Japan) Kidneys filter extra water and waste from the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to properly filter blood. In people with T2D, the body does not make enough of a hormone called insulin or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. The new drug, finerenone, works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys. By lowering their stimulation, finerenone reduces the risk of progressive worsening of the kidney disease. Finerenone is available and approved in several countries for doctors to prescribe to people with CKD and T2D. The main purpose of the study is to collect and describe characteristics of participants in each treatment group who have started or will start treatment before and after finerenone became available. To do this, the researchers will collect data on: * Patient characteristics (e.g., age sex) of the participants * Clinical characteristics (e.g., history of CKD and T2D, heart and liver health, other health problems) of the participants * Treatments for T2D and CKD * Other medications used Data will be grouped by type of treatment that is initiated (e.g., SGLT2i, a GLP-1 RA, a sMRA, finerenone, or other nsMRA). Two time periods will be compared. Study period I is the time until finerenone became available in the respective country, starting from 2012 (2014 for Japan). Study period II will begin when finerenone becomes available in the respective country and will end at the end of the study (planned in September 2024). Researchers will also collect data on treatment patterns and changes for each type of treatment in both time periods. Health care data will be collected from various sources in five countries (e.g., Denmark, the Netherlands, Spain, Japan, and the US). The patients will receive their treatment as prescribed by their doctors during routine practice according to the approved product information. Each patient will be in the study from first use (in Study period I and II) of one of the listed drug classes until: * End of study * The data are somehow no longer available * The patient leaves or has to leave the study
NASH成人患者を対象としたGSK4532990の第2b相試験
The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4). The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.
代謝機能障害関連脂肪肝炎（MASH）と呼ばれる慢性肝疾患の遺伝的リスクが高い成人患者を対象に、遺伝子サイレンシングを用いた精密医療アプローチによる治療
この研究は、「試験薬」と呼ばれる治験薬ALN-HSDを研究するものです。この研究は、代謝機能障害関連脂肪肝炎（MASH）の既往歴のある被験者を対象としています。MASHは、代謝機能障害関連脂肪肝疾患（MASLD）の一種です。MASHは、肝細胞に脂肪が蓄積し、細胞を損傷することで発症します。線維化（瘢痕組織）により肝臓が炎症を起こし、硬くなります。MASHは肝硬変（長期的な瘢痕形成）や肝不全（肝臓が機能不全に陥る状態）へと進行する可能性があります。この研究の目的は、試験薬がMASHに関連する肝瘢痕形成の副作用を軽減する効果を確認することです。 この研究では、以下の研究課題も検討しています。 * ALN-HSDがどのように肝機能を改善し、肝臓におけるMASH関連の炎症を軽減するのか * 治験薬の投与によってどのような副作用が起こる可能性があるのか * 治験薬および治験薬代謝物（治験薬が体内で分解される際に生じる副産物）が、様々な時点で血中にどれだけ存在するのか * 治験薬とMASHに関する理解を深める
肺動脈性高血圧症の日本人小児患者を対象としたマシテンタンの試験
The purpose of this study is to evaluate the effect of macitentan on hemodynamic measures at Week 24 in pediatric populations.
オピオイドを服用している小児被験者におけるナルデメジンの安全性および薬物動態試験
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.
中等度から重度の尋常性乾癬患者を対象としたJNJ-77242113の研究
Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.
活動性特発性炎症性筋疾患患者におけるニポカリマブの研究
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
掌蹠膿疱症（PPP）の日本人患者を対象としたアプレミラストの第3相ランダム化試験
The primary objective of the study is to evaluate the efficacy of apremilast (AMG 407) twice daily (BID) compared with placebo in participants with Palmoplantar Pustulosis (PPP).
心血管疾患患者におけるオビセトラピブの効果を評価する心血管アウトカム研究
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy.
GORE® CARDIOFORM 隔壁閉塞器に関する日本郵政による調査
The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.
CagriSemaが2型糖尿病と過剰体重の患者の減量にどれほど効果的かを調べる研究
This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
過体重または肥満の東アジア人におけるセマグルチド錠の1日1回服用の効果を調査する研究
Novo Nordisk are doing this study to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants' body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation. Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning. In addition to taking the medicine, participants will have talks with study staff about: * healthy food choices * how to be more physically active * what participants can do to lose weight The study will last for about 1½ year. Participants will have 14 clinic visits and 7 phone calls with the study healthcare professional. Blood samples will be taken at 12 visits. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period. If participants are a woman and are able to become pregnant, participants will be checked for pregnancy via urine tests.
急性骨髄性白血病（AML）の完全寛解期にある日本人患者における維持療法としての経口アザシチジン＋ベストサポーティブケアとベストサポーティブケア単独の有効性と安全性を比較する試験
The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.