治験一覧
8,963 件中 1481〜1500 件を表示
進行性固形悪性腫瘍を有する日本人患者を対象としたセララセルチブの非盲検第1相試験
This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ceralasertib in Japanese patients with advanced solid malignancies. Cycle 0 duration is 4 days and each cycle from Cycle 1 has a duration of 28 days.
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%.
声帯瘢痕患者を対象としたKP-100LIの第3相試験
The purpose of this study is to confirm the efficacy and safety of KP-100LI, a intracordal formulation containing recombinant human dHGF as the active pharmaceutical ingredient, for voice function improvement therapy in patients with vocal fold scar (including vocal fold sulcus).
ビクテグラビル/エムトリシタビン/テノホビルアラフェナミド（BIC/FTC/TAF）でウイルス学的抑制が認められたヒト免疫不全ウイルス1型（HIV-1）患者におけるドラビリン/イスラトラビル（DOR/ISL）への切り替え（MK-8591A-052）
The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.
ブライトライン1：脱分化型脂肪肉腫と呼ばれる癌患者におけるブリギマドリン（BI 907828）とドキソルビシンの比較試験
This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. The purpose of this study is to compare a medicine called brigimadlin (BI 907828) with doxorubicin in people with liposarcoma. Brigimadlin (BI 907828) is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either brigimadlin (BI 907828) or doxorubicin. Every 3 weeks, participants take brigimadlin (BI 907828) as tablets or doxorubicin as an infusion into a vein. Participants can switch to brigimadlin (BI 907828) treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and can tolerate it. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.
安定したスタチン療法への補助療法としてのオビセトラピブの効果を評価するための日本人患者を対象とした用量探索試験。
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy.
未治療の進行胃がんまたは胃食道接合部がん患者を対象に、ベマリツズマブと他の抗がん療法の併用を評価する研究。
The main objectives of this study are to evaluate the safety and tolerability of bemarituzumab in combination with other anti-cancer therapies, and to evaluate the efficacy of bemarituzumab in combination with S-1 and oxaliplatin (SOX) and nivolumab as assessed by objective response.
進行固形腫瘍における抗CEACAM5 ADC M9140（PROCEADE-CRC-01）
The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2). Study details include: * Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2 * M9140 is not available through an expanded access program
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.
急性視神経炎ネットワーク：初めて急性視神経炎を発症した被験者を対象とした国際研究
The goal of this observational study is to longitudinally investigating subjects with inaugural acute optic neuritis (ON). The main questions it aims to answer are: * Does the time to corticosteroid treatment affect the visual outcome at 6 months in subjects with acute multiple sclerosis (MS)-, aquaporin 4-IgG positive (AQP4-IgG+) and myelin-oligodendrocyte-glycoprotein-IgG positive (MOG-IgG+) ON? * How differ clinical, structural, and laboratory biomarkers in subjects with acute ON, including clinical isolated syndrome (CIS), MS-ON, AQP4-IgG+ON, MOG-IgG+ON and seronegative non-MS-ON? Participants will undergo * clinical examination, including clinical history, neurovisual and neurological tests * serum and cerebrospinal fluid examination * optical coherence tomography (OCT) * magnetic resonance imaging (MRI) * assessment of depression, pain, quality of life through validated questionnaires Researchers will compare subjects with MS-ON, AQP4-IgG+ON, MOG-IgG+ON and other ON (CIS, seronegative non-MS-ON) to detect diagnostic and predictive markers for the disease course.
Scemblix錠の特別薬物使用結果監視
Uncontrolled, central registration system, all-case, multicenter, special drug use-results surveillance.
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.
進行固形腫瘍に対するリナタバートセステカン（Rina-S、PRO1184、GEN1184）（GCT1184-01/ PRO1184-001）
この研究では、固形がん患者を対象に、副作用を含む安全性を検証し、リナSと呼ばれる薬剤の特性を明らかにします。 被験者は、全身に転移した（転移性）固形がん、または手術で切除できない（切除不能）固形がん患者です。
プラチナ製剤耐性再発卵巣癌に対するペムブロリズマブ/プラセボ+パクリタキセル+ベバシズマブ併用または非併用療法（MK-3475-B96/KEYNOTE-B96/ENGOT-ov65）
The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.
健康な被験者およびアトピー性皮膚炎患者におけるLY3844583の研究
The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in healthy participants and participants with atopic dermatitis. The study will also assess how fast LY3844583 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants and participants with atopic dermatitis. The study will be conducted in three parts and each participant will enroll in one part. The study will last up to 88, 116, and 186 days with 10, 13, and 14 visits for each participant in parts A, B, and C, respectively.
ARBを服用中のFSGS患者におけるDMX-200の有効性と安全性に関する研究
DMX-200（レパゲルマニウム）はC-Cケモカイン受容体2型（CCR2）阻害剤であり、ARBとの併用投与により、慢性疾患の炎症性ケモカイン環境に関与する単球の動員を阻害するよう設計されています。このピボタルランダム化二重盲検試験の目的は、ARBによる治療を受けているFSGSの成人患者を対象に、104週間の治療期間にわたり、DMX-200 120 mgを1日2回（BID）投与した場合の有効性と安全性をプラセボと比較することです。この疾患の希少性とFSGSの成人および小児患者の類似性を考慮し、ダイメリックス社は12歳から17歳の青年におけるDMX 200の有効性と安全性も調査します。二重盲検期間の後には、DMX 200の長期的な有効性と安全性を最大2年間評価することを目的とした非盲検延長試験（OLE）が行われます。
BI 690517の異なる用量を単独またはエンパグリフロジンとの併用で投与した場合、慢性腎臓病患者の腎機能が改善するかどうかを検証する研究
This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study. The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin. In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine. In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.
閉塞性睡眠時無呼吸マスタープロトコルGPIF：閉塞性睡眠時無呼吸患者におけるチルゼパチド（LY3298176）の研究
The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI1 and those who are and plan to stay on PAP therapy in GPI2.
白内障眼における単焦点トーリック眼内レンズ（IOL）の臨床研究
This is a Multi-center, single-arm and non-masked study whereby patients undergoing routine cataract surgery be implanted with a hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (model POD T 49P).
アテローム性動脈硬化性心血管疾患（ASCVD）の既往歴を有する患者におけるリポタンパク質（a）レベルの横断的研究
The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold: * Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD * Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions