治験一覧
8,963 件中 81〜100 件を表示
アトピー性皮膚炎の成人患者を対象とした、1% OPA-15406フォームの基剤に対する優位性を実証する第3相試験
To investigate the superiority of 1% OPA-15406 foam to the vehicle in adult patients with atopic dermatitis (AD).
子宮内膜症患者におけるKLH-2109の臨床試験
To verify the non-inferiority of KLH-2109 to leuprorelin acetate in a double-blind manner in terms of efficacy in endometriosis patients with pelvic pain.
ラクナ梗塞の超急性期における新規アプローチレジメンの臨床利用：Rt-PA vs. DAPTランダム化臨床試験
この臨床試験の目的は、小規模虚血性脳卒中（ラクナ脳卒中）の治療において、抗血小板薬の併用が静脈内組織プラスミノーゲンアクチベーター投与よりも有効かどうかを明らかにすることです。主な疑問は以下のとおりです。 抗血小板薬の併用は、現在の標準的な組織プラスミノーゲンアクチベーター治療に非劣性であるか？抗血小板薬の併用は、組織プラスミノーゲンアクチベーター投与よりも出血性合併症を軽減するか？ 研究者らは、抗血小板薬の併用が小規模虚血性脳卒中（ラクナ脳卒中）の治療に有効かどうかを調べるため、抗血小板薬の併用と組織プラスミノーゲンアクチベーター投与を比較します。 参加者は以下のことを行います。 抗血小板薬の併用または静脈内組織プラスミノーゲンアクチベーター投与を受ける。脳卒中後3ヶ月で、対面、電話、または郵送で神経学的状態を確認します。
進行固形腫瘍患者を対象とした、CBA-1535（T 細胞誘導剤（5T4/CD3/5T4））の第 I 相、初めてのヒト研究。
This is a First in Human muticenter, non-randomized, open-label Phase I dose-escalation study of CBA-1535. The study will have 2 parts (Part 1 and Part 2). Part 1 is the dose-escalation cohorts of CBA-1535 single agent theapy. Part 2 is the dose-escalation cohorts of CBA-1535 in combination with Pembrlizumab. This study will evaluate the safety, tolerability, PK, biomarker profiles and preliminary efficacy of CBA-1535.
常染色体優性多発性嚢胞腎（ADPKD）の成人患者におけるABBV-CLS-628の静脈内注入の有害事象および有効性を評価する研究
常染色体優性多発性嚢胞腎（ADPKD）は、腎臓に液体が貯留した嚢胞が形成される腎疾患の最も一般的な遺伝的原因です。本試験の目的は、成人被験者におけるADPKD治療におけるABBV-CLS-628の安全性と有効性を評価することです。 ABBV-CLS-628は、ADPKD治療薬として開発中の治験薬です。被験者は、治療群と呼ばれる4つのグループのいずれかに分けられます。各グループは異なる治療を受けます。被験者がプラセボに割り付けられる確率は4分の1です。世界約100の施設で、約240名のADPKD成人被験者が登録されます。 被験者は、92週間にわたり、4週間ごとにABBV-CLS-628またはプラセボを静脈内投与されます。被験者は最大15週間追跡されます。 この試験の参加者は、標準治療と比較して治療負担が大きくなる可能性があります。試験期間中、参加者は定期的に病院またはクリニックを受診していただきます。治療の効果は、医学的評価、血液検査、副作用の確認、アンケートへの回答によって確認されます。
中等度から重度の活動性潰瘍性大腸炎患者におけるドゥバキトゥグの有効性と安全性を調査するための導入試験
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.
再発性/転移性頭頸部癌患者における標準治療薬（SOC）へのアミバンタマブ追加投与とSOC単独投与との比較試験
The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.
切除不能肝外胆管癌に対する反復胆管内高周波アブレーション＋デュルバルマブ、ゲムシタビン、シスプラチン
This international, multicenter, open-label randomized controlled trial evaluates whether repeated endobiliary radiofrequency ablation (EB-RFA) improves overall survival in patients with unresectable extrahepatic cholangiocarcinoma undergoing first-line systemic therapy with durvalumab plus gemcitabine and cisplatin (GCD). Eligible patients will be randomized 1:1 to EB-RFA with plastic stent placement or standard plastic stenting alone. A scheduled second endoscopic session will be performed at 3 months in both groups (repeat EB-RFA only in the EB-RFA arm). The primary endpoint is overall survival. Secondary endpoints include time to recurrent biliary obstruction, progression-free survival, adverse events, and technical/clinical success.
トリプルネガティブ乳がんに対するペムブロリズマブ＋パクリタキセル＋／－ベバシズマブ
* Breast cancer is histologically divided into non-invasive (approximately 10%) and invasive (approximately 90%), with invasive cancer being the target of chemotherapy. Invasive carcinoma is classified into four subtypes according to the expression levels of hormone receptor (HR) and human epidermal growth factor receptor type 2 (HER2). Among them, triple negative breast cancer accounts for 10% of invasive cancers and is the subtype with the poorest prognosis. * For triple negative breast cancer that is operable, chemotherapy with pembrolizumab is administered either preoperatively or postoperatively (perioperative period). For recurrent triple negative breast cancer , combination chemotherapy with multiple agents is the standard of care, especially in the case of PD-L1-positive patients, chemotherapy with an immune checkpoint inhibitor related to PD-1 (pembrolizumab or atezolizumab) is administered. * Although the KEYNOTE355 trial demonstrated the efficacy of pembrolizumab plus paclitaxel therapy in patients with PD-L1-positive triple negative breast cancer in postoperative relapse, this trial did not include patients who received pembrolizumab in the perioperative period. Therefore, it is not known if there is any benefit to re-administering pembrolizumab to these patients after relapse. * Bevacizumab is used as standard therapy for triple negative breast cancer in combination with paclitaxel. Bevacizumab itself is an anti-tumor agent that inhibits angiogenesis, but has also been reported to activate immunity against cancer, suggesting that it may enhance the effect of pembrolizumab. Based on the above, the investigators planned this trial to evaluate whether pembrolizumab + paclitaxel + bevacizumab therapy is more effective than pembrolizumab + paclitaxel therapy in PD-L1-positive triple negative breast cancer patients who relapse after receiving immune checkpoint inhibitors in the perioperative period.
中等度から重度のアルコール使用障害患者を対象としたブレニパチドの研究
The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use Disorder (AUD). Participation in this study will last approximately 56 weeks.
分化型甲状腺癌患者を対象としたAf-001の第I相試験
This trial consists of 2 parts, i.e., Part Ia and Ib. The Part Ia is to evaluate the safety and tolerability of a single intravenous dose of af-001 in patients with radically unresectable, recurrent, metastatic differentiated thyroid cancer (papillary carcinoma, follicular carcinoma) refractory to or intolerant of standard-of-care therapy, who have received total thyroidectomy, and to determine the MTD (Maximum tolerated dose). Part Ib is to evaluate the efficacy and safety of af-001 mutiple doses to patients with radically unresectable, recurrent, metastatic differentiated thyroid cancer (papillary carcinoma, follicular carcinoma), who have received total thyroidectomy and are RAI naïve, randomized into two arms at the determined MTD or the MTD-1 dose level, and to determine the recommended Phase II dose (RP2D)
膵頭十二指腸切除術における三面および片面マットレス膵空腸吻合の比較
In pancreaticojejunostomy following pancreaticoduodenectomy for soft pancreas, a randomized controlled trial will be conducted to compare a patient group using the conventional Blumgart modified technique and a patient group in which mattress sutures are added to the cranial and caudal sides of the pancreaticojejunostomy after the Blumgart modified technique (three-sided mattress suture technique), and to evaluate the safety and usefulness of the three-sided mattress suture technique by comparing the incidence of pancreatic fistula (ISGPF grade B or C).
プラチナ製剤併用療法に難治性または不耐容の進行小腸腺癌患者におけるエンフォルツマブ・ベドチン
Small bowel adenocarcinoma is a rare cancer with a poor prognosis. For patients with locally advanced or metastatic disease, the usual first treatment is chemotherapy with platinum-based combinations such as FOLFOX or CapeOX. However, once the cancer grows after this treatment or the side effects become too severe, there is no widely accepted standard second-line therapy, and outcomes are generally poor. New treatment options are therefore urgently needed. Recent retrospective research from our group has shown that the majority of the small bowel adenocarcinomas strongly express a protein called Nectin-4 on the surface of cancer cells. High Nectin-4 expression was also associated with poorer survival, suggesting that Nectin-4 could be a crucial treatment target in this disease. Enfortumab vedotin is a targeted anticancer drug called an antibody-drug conjugate. It combines an antibody that recognizes Nectin-4 with vedotin, a cytotoxic anticancer agent (payload). After enfortumab vedotin binds to Nectin-4 on the tumor cell surface, it is taken up into the cell and releases the anticancer payload, which damages the cell's internal structure and leads to cell death and apoptosis. Enfortumab vedotin has already shown meaningful antitumor activity and an acceptable safety profile in patients with advanced urothelial carcinoma and is approved over the world. However, its efficacy has never been formally evaluated in patients with small bowel adenocarcinoma. ENVELOPE is a multicenter, single-arm, phase II investigator-initiated trial designed to evaluate the efficacy and safety of enfortumab vedotin in patients with locally advanced or metastatic small bowel adenocarcinoma that has progressed during or after, or is intolerant to, platinum-based combination chemotherapy (FOLFOX or CapeOX). Eligible patients are adults (aged 18 years or older) with histologically or cytologically confirmed small bowel adenocarcinoma, a good performance status, adequate organ function, and at least one measurable lesion on a CT scan. Patients who have genomic alterations that make them candidates for previously approved "tumor-agnostic" targeted drugs (for example, high microsatellite instability or high tumor mutational burden) must already have tried and not benefited from, or not tolerated, those treatments. Testing positive for Nectin-4 is not required to take part in this study. Participants will receive enfortumab vedotin as an intravenous infusion at a dose of 1.25 mg/kg on days 1, 8, and 15 of each 28-day treatment cycle. Treatment will continue as long as the cancer does not grow and side effects remain manageable. Tumor scans with contrast-enhanced CT will be performed every 8 weeks up to week 24 and every 12 weeks thereafter to monitor the response of the enfortumab vedotin. The primary objective is to determine the proportion of patients achieving a tumor response to enfortumab vedotin, as assessed by independent radiologic review. Key secondary objectives include progression-free survival, overall survival, duration of response, and safety profiling. In addition, this study includes a prespecified translational research program. Tumor samples will be examined for Nectin-4 expression using immunohistochemistry, and researchers will investigate the relationship between Nectin-4 levels and the effects of enfortumab vedotin. Blood and tissue samples will also be collected before treatment, during treatment, and at the time of cancer progression, when possible, for detailed "multi-omics" analyses. These translational studies aim to elucidate why some patients respond whereas others do not, and to identify biomarkers that could inform future treatment strategies for small bowel adenocarcinoma. The ENVELOPE trial has been approved by the Institutional Review Board of the National Cancer Center, Japan, as well as by the ethics committees at participating sites. The study is funded by the Japan Agency for Medical Research and Development (AMED), and enfortumab vedotin is supplied by Astellas Pharma. Enrollment began in October 2025 and is planned to continue through October 2027, with patients followed for at least 12 months after the last participant is enrolled.
エルゴチオネイン含有サプリメントの継続摂取による皮膚状態への影響
This trial employed a non-randomized, double-blind, placebo-controlled design to evaluate the effects of DR. ERGO® Capsules (each containing 30mg of ergothioneine) on the skin condition of women aged 35 to 59 after continuous daily intake for 8 weeks. The trial assessed skin condition across multiple dimensions, including brightness, color tone, melanin, erythema, gloss, elasticity, and spots, using various instruments and questionnaire surveys. Additionally, safety was monitored through daily log records and safety evaluations.
MTAP欠失ホモ接合体を有する、治療歴のある進行性または転移性非小細胞肺癌（NSCLC）患者を対象としたBMS-986504の試験（MountainTAP-9）
この研究の目的は、以前の治療で病勢進行したホモ接合型 MTAP 欠失を伴う進行性または転移性非小細胞肺癌 (NSCLC) の参加者における BMS-986504 単独療法の安全性と有効性を評価することです。
クレオパトラ：トランスサイレチンアミロイド（ATTR）アミロイドーシスによる心不全患者におけるコラミツグ（NNC6019-0001）と呼ばれる薬剤による治療効果を調査する研究
This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.
パイロットスタディ：CCP介入がNICU環境と早産児の発達に及ぼす影響
Close Collaboration with Parents intervention is an evidence-based educational intervention for the entire multi-professional staff of neonatal intensive care units (NICUs). The goal of the intervention is to strengthen partnership between staff and parents, enhance parental participation in infant care. There are no studies yet about the effects of the Close Collaboration with Parents intervention on the long-term neurodevelopment and socio-emotional development of very preterm infants and their interaction with their parents. Accordingly, a multicenter cluster randomized controlled trial is planned. Prior to initiating this large-scale study, it is essential to validate the measurement instruments. Therefore, a pilot study will be conducted to assess their feasibility and to determine the appropriate sample size.
新生血管性加齢黄斑変性症および糖尿病黄斑浮腫を有する日本人患者におけるアフリベルセプトの日常診療での使用についてさらに詳しく知るための研究
This is an observational study in which data already collected from participants with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. The eye disorders, nAMD and DME, affect the macula, the central part of the retina at the back of the eye. This leads to blurry vision or blind spots, making everyday activities like reading or sewing difficult. While nAMD is linked to aging, DME is related to diabetes. Both conditions require similar treatment to help improve vision. Aflibercept 8 milligrams (mg) is already approved in Japan for doctors to prescribe to people with nAMD or DME. It is a drug injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF), which causes abnormal growth and leakage of blood vessels at the back of the eye. The participants in this study are already receiving treatment with aflibercept 8 mg as part of their regular care from their doctors. There is limited data available on the use of aflibercept 8 mg in Japan. Data from routine medical practice will inform treatment in Japanese and other Asian populations. The main purpose of this study is to learn more about the disease and patient characteristics of Japanese participants with nAMD and/or DME who receive aflibercept 8 mg during their routine healthcare, and how they use it. To learn this, the study will use 2 methods: Method 1: Researchers will study the health details of participants when they first started aflibercept 8 mg. Method 2: Researchers will study the participants' data collected over 1 year to see how they used aflibercept 8 mg. The data will come from a claims database called DeSC Healthcare Inc. The data will be collected from April 2023 to March 2025 for Method 1, and from April 2023 to March 2026 for Method 2. Researchers will only look at the information from participants in Japan. In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
リヒター変換患者を対象としたONO-4538試験
Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation
高血圧および肥満または過体重の参加者を対象としたオルフォルグリプロン（LY3502970）のマスタープロトコル試験（ATTAIN-Hypertension）GZL1
GZL1 is an independent study conducted under the GZPL master protocol. GZL1 will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.