治験一覧
8,963 件中 1781〜1800 件を表示
血液悪性腫瘍を有する日本人患者を対象とした、治験薬（マプリルパセプト（PF-07901801））に関する調査研究
The purpose of this clinical trial is to learn about how safe and tolerable is the study medicine (called maplirpacept (PF-07901801)) when taken for the treatment of lymphoma or multiple myeloma (a type of cancer that affects your body's infection-fighting cells, lymphocytes or plasma cell). This study is seeking participants who: * are 18 years of age or older * have worsening and difficult to manage type of lymphoma or multiple myeloma * Have adequately functioning organs * are not on long term use of steroids which are given either by mouth or as shots * have no major heart related disease etc. All participants in this study will receive maplirpacept (PF-07901801) as an IV infusion (given directly into a vein) at the study clinic every week. Participants will continue to receive maplirpacept (PF-07901801) until their progress of cancer worsens or the participants do not wish to take the study medicine. The experiences of the people receiving the study medicine will be collected. This will help to understand if the study medicine maplirpacept (PF-07901801), is safe and can be given to Japanese people.
脳卒中研究におけるsCLEC-2
Any platelet function tests have not been widely used in the clinical practice of acute cerebrovascular disease because of the concerns in repeatability, economic performance, and simplicity. Soluble C-type lectin-like receptor 2 (sCLEC-2) is a new marker for platelet activation, which can be easily measured by usual blood collection in routine clinical practice. We planned the sCLEC-2 in Stroke (CLECSTRO), which is a prospective cohort study in patients with acute ischemic stroke (AIS) and transient ischemic attack (TIA). We planned the sCLEC-2 in Stroke (CLECSTRO), which is a prospective cohort study in patients with acute ischemic stroke (AIS) and transient ischemic attack (TIA). The purpose of this study is to evaluate the clinical utility of sCLEC-2 as a biomarker for pathophysiology, differential diagnosis, prediction of prognosis, and monitoring of antiplatelet therapy in patients with AIS and TIA. Subjects are patients with AIS or TIA and control patients required for differentiation from AIS or TIA. The target population is 600 including the patients and the controls. The outcomes include difference in plasma sCLEC-2 level between patients with AIS or TIA and patient controls, correlation between sCLEC-2 after antithrombotic therapy and recurrence or worsening of stroke, difference in sCLEC-2/D-dimer ratio between non-cardioembolic and cardioembolic AIS or TIA, and correlation between baseline sCLEC-2 and outcome (modified Rankin scale score) after 3 months. sCLEC-2 could be a widely useful biomarker to contribute to the progress of precision medicine in clinical practice of AIS and TIA.
サイトメガロウイルス（CMV）感染症の日本人におけるマリバビルに関する研究
The main aim of the study is to check if maribavir can treat Japanese people with Cytomegalovirus (CMV) infection, and to check side effect from the study treatment and how much maribavir participants can take without getting side effects from it. Japanese recipients of a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) will take Maribavir tablets two times a day for 8 weeks in this study. During the study, participants will visit their study clinic 18 times as a maximum.
慢性副鼻腔炎および鼻ポリープ患者におけるデペモキマブ（GSK3511294）の有効性と安全性（ANCHOR-2試験）
This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).
アムリテリマブ中等度から重度のアトピー性皮膚炎臨床試験参加者におけるアムリテリマブの長期安全性および有効性評価
This is an open-label, Phase 2/Phase 3, long-term extension study for treatment of participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis. The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated participants with moderate to severe atopic dermatitis (AD) who have previously been enrolled in an amlitelimab clinical trial. All participants will have visits during the treatment period every 4 weeks. Responder participants rolling over from EFC17599 and EFC17600, and responder participants enrolling through screening from DRI17366 will be initiated into drug withdrawal (with no drug administration) at LTS17367 baseline visit to monitor durability of treatment response. If these responder participants relapse during LTS17367, they will have treatment restored. Non-responder participants rolling over from EFC17599 or EFC17600, and non-responder participants enrolling through screening from DRI17366 will have treatment administration from LTS17367 baseline. Participants rolling over from DRI17366, SFY17915 and INT18404 will also have treatment administration from LTS17367 baseline. Remote visits with home dosing are allowed for the purpose of study drug administration, when applicable. In the case of remote visit with home dosing, the participant or a caregiver may administer study drug after appropriate training. Alternatively, if needed, and based on the investigator's judgement, home visits with healthcare professional assistance or on-site study drug administration visits can be performed. Where participants discontinue amlitelimab permanently during LTS17367, safety follow up will be performed for a minimum of 140 days from the last amlitelimab administration.
HER2陰性で切除不能な進行性または再発性胃癌（食道胃接合部癌を含む）の化学療法未治療患者を対象に、ONO-4538とイピリムマブおよび化学療法を併用した場合の有効性および安全性を評価する研究
This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
転移性非小細胞肺癌患者を対象とした、ペムブロリズマブ/ビボストリマブ配合剤（MK-7684A）と化学療法の併用とペムブロリズマブ+化学療法の併用を比較する試験（MK-7684A-007/KEYVIBE-007）
The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.
大腸内視鏡検査におけるプロポフォール鎮静（> 200 mg）の安全性。
This study examines that the use of \>200 mg of propofol sedation enables patients to drive home safely after outpatient colonoscopy.
2型糖尿病患者における治験薬（PF-07081532）およびリベルサスの効果、ならびに肥満患者におけるPF-07081532の効果を個別に評価する治験
The purpose of this study is to find out if PF-07081532 ("the active study drug"), is safe and helps treat people with obesity without diabetes to lose weight, and people with diabetes to keep their blood sugar in good control. Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study. Those participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus. Those in the obesity part of the study, will receive either active study drug or placebo. The study will last for about 36 weeks except for the first 25% of the participants that enter in which case the study will last for approximately 48 weeks. during this time there will be visits every 4 weeks with phone calls in between.
VAXZEVRIAの長期安全性に関する日本における市販後調査（PMS）
This survey will be conducted for the subjects who participate in the priority survey (cohort survey) conducted by the Scientific Research Group of the Ministry of Health, Labour and Welfare at the initial stage of administration of the COVID-19 vaccination. The present study aims to collect information on serious adverse events or COVID-19 infection observed from 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination and to evaluate the long-term safety of this vaccine.
PD-1/PD-L1阻害剤療法の適応とならない局所再発性手術不能または転移性トリプルネガティブ乳がん患者におけるDato-DXdと治験担当医選択化学療法の比較試験（TROPION-Breast02）
This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
成長に支援が必要な小児におけるソマパシタン週1回投与とノルディトロピン®1日1回投与を比較する研究
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for upto 5.5 years. The participants will either get somapacitan once a week up to 5.5 years or Norditropin® once a day for 1 year followed by somapacitan once a week for up to 4.5 years. Which treatment the participants get is decided by chance.
最大耐容性脂質修飾療法に対するオビセトラピブの効果を評価するランダム化試験
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy
活動性ループス腎炎患者におけるセクキヌマブの有効性、安全性および忍容性に関する非盲検継続試験
The purpose of this open-label extension study was to provide treatment with secukinumab for subjects who completed core study treatment in Study CAIN457Q12301 (NCT04181762), and to obtain further data on long-term efficacy, safety and tolerability of secukinunab in patients with active lupus nephritis (LN).
膝関節炎に伴う疼痛に対するRTX-GRT7039注射剤の安全性と忍容性を確認するためのオープンラベル試験
An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.
SCLE、DLE、および/またはSLE患者を対象としたM5049を用いたWillow LTE試験（WILLOW LTE）
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569\_0003 \[NCT05162586\]).
特定の進行癌患者におけるKFA115単独およびペムブロリズマブとの併用の安全性と有効性に関する研究
The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with pembrolizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or recommended dose.
非閉塞性肥大型心筋症におけるマバカムテンの研究
The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
nAMD患者を対象としたRGX-314遺伝子治療のピボタル2試験
ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.
先天性副腎過形成症患者を対象としたクロノコートの長期安全性試験
This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries. The study will evaluate the long-term safety and tolerability of Chronocort in participants aged 16 years and over when used as treatment for Congenital Adrenal Hyperplasia (CAH).