治験一覧
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実臨床における転移性去勢抵抗性前立腺癌（mCRPC）患者のHRR関連遺伝子変異の有病率と予後
The purpose of this study is to investigate the prevalence of tissue homologous recombination repair (HRR)-related gene mutations (positive/negative/Variant of uncertain significance (VUS)), clinical outcome such as prostate-specific antigen-progression free survival (PSA-PFS), overall survivals (OS) and treatment pattern in mCRPC patients. \<Methods\> Study design: multi-center, prospective cohort study Data Source(s): In this study, 155 patients (expected recruitment patients: maximum 205 patients) will be enrolled from approximately 20\~30 sites in Japan. Study Population: mCRPC patients who diagnosed between 2014 and 2018. Exposure(s): N.A Outcome(s): Prevalence of tissue HRR-related gene mutations, clinical outcomes such as Over survival and PSA-PFS, Treatment pattern Sample Size Estimations: The target population is 155 patients based on the prevalence of HRR-related genes (BRCA1, BRCA2 and ATM) which is reported in previous global study (PROfound study). Statistical Analysis: This study is not intended to verify specific hypotheses, and the results are evaluated descriptively. There is no plan of interim analyses before the final analysis.
METエクソン14スキッピング変異を有する進行非小細胞肺癌患者におけるカプマチニブおよびスパルタリズマブ／プラセボの併用療法に関する研究
A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy and safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus capmatinib and placebo as first line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METΔex14) mutations
持続血糖モニタリング下におけるアテローム性動脈硬化の進行と脆弱性
The OPTIMAL is a single-center, randomized trial to evaluate the efficacy of CGM-based glycemic control on atheroma progression in T2DM patients with CAD by using serial intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) imaging. A total of 90 eligible subjects will be randomized 1:1 into 2 groups to receive either CGM-based glycemic control or HbA1c-baded glycemic management. Coronary angiography and NIRS/IVUS imaging is repeated at the end of the assigned treatment period. Results: The primary endpoint is the normalized absolute change in total atheroma volume from baseline to 12 months. The secondary endpoints include (1) the absolute change in percent atheroma volume, (2) the percent change in lipid core burden index, (3) the change in coefficient variance measured by CGM, (4) the change in atherogenic markers (high-density lipoprotein functionality, proprotein convertase subxilisin/kexin type 9 and fatty-acid binding proteins), and (5) the frequency of hypoglycemia. Safety will also be evaluated.
抗ヒスタミン剤の使用にもかかわらず症状が持続する慢性特発性蕁麻疹患者におけるベンラリズマブの使用を調査する研究（ARROYO）
The purpose of this study is to investigate the use of benralizumab is effective in the treatment of chronic spontaneous urticaria (CSU) who are symptomatic despite the use of antihistamines.
nAMD患者におけるブロルシズマブの安全性を評価するための52週間の観察研究
This study was a prospective, uncontrolled, central registration system, multicenter, domestic observational study (special drug-use surveillance) to evaluate the safety of 52-week clinical treatment with Beovu kit for intravitreal injection in nAMD patients.
PICと病的近視の進行におけるその役割
Aim of the work PIC in pathological myopia has not been well documented due to difficult in diagnosis we conducted this retrospective study to characterize the clinical features of PIC in high myopic eye. * To show the diagnostic criteria of PIC lesions in high myopic patients. * Find out the prevalence of PIC related 'patchy atrophy' * To determine risk factor for developed PIC in a series of highly myopic patients. * Role of PIC in progression of high myopia. * Calculate the progression rate of PIC related lesion, by the size change during follow-up. * Search about complication of PIC in myopia. Patient and Methods This retrospective observational case series study included patients with high myopia who had been examined and followed-up in the High Myopia Clinic of the Tokyo Medical and Dental University. Approval from Ethics Committee of Tokyo Medical and Dental University was obtained, adhering to the tenets of Declaration of Helsinki. Signed informed consent documentation was obtained from all participants. All study participants underwent a detailed ophthalmologic examination at baseline and at each follow-up visit. The examinations included measurements of best-corrected visual acuity (BCVA) using a Landolt C chart, refraction, slit lamp biomicroscopy, biometry for determination of axial length, (IOL Master; Carl Zeiss Meditec Co, Jena, Germany), fundus examination in medical mydriasis, fluorescein angiography, was performed with and colour fundus photography , and assessment of fundus autofluorescence (TRC-50DX; Topcon, Tokyo, Japan) a or the Heidelberg Spectralis HRA system. Swept source Optical coherence tomography (OCT) used in assessment of the RPE and photoreceptors using a (DRI-OCT;Topcon, Tokyo, Japan). As scanning protocols, 9 mm or 6 mm radial with 12 equal meridian scans were performed. The swept-source OCT device has an A-scan repetition rate of 100 000 Hz, and its light source operates in the wavelength range of 1 μm.
HIV-1感染リスクの高い男性およびトランスジェンダー女性における曝露前予防（PrEP）としての経口イスラトラビル（MK-8591）（MK-8591-024）
The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men and who are at high risk of HIV-1 infection with 48 or 96 weeks of treatment and a minimum follow-up of 42 days.
再発・難治性マントル細胞リンパ腫の成人日本人患者におけるベネトクラックス錠（経口）とイブルチニブカプセル（経口）の併用による完全奏効（BCR）に対する効果を評価する試験
Mantle Cell Lymphoma (MCL) is a form of Non-Hodgkin Lymphoma (NHL - cancer of the lymphatic system in blood) where cells from outer edge of the lymph nodes, called mantle zone become cancerous. In Japan, MCL accounts for about 3% of all NHL cases. Symptoms of MCL may include enlarged lymph nodes, stomach pain, fever, night sweats, and weight loss. Currently, MCL is not curable with standard therapies. The purpose of this study is to evaluate the safety, efficacy, and effect of venetoclax in combination with ibrutinib on best overall response of complete response in participants with relapsed (return of disease) or refractory (not responding to treatment) (R/R) MCL. Venetoclax is an investigational drug being developed for the treatment of MCL. Ibrutinib is a drug approved for the treatment of MCL. Participants will receive venetoclax (increasing doses) and ibrutinib (fixed dose) for approximately 104 weeks, followed by ibrutinib alone. Adult participants with R/R MCL will be enrolled. Around 12 participants will be enrolled in Japan. Participants will receive oral venetoclax tablet and oral ibrutinib capsule for 104 weeks. After 104 weeks, participants will receive ibrutinib once daily until their disease progresses, or they cannot tolerate the medication, or until they do not want to participate in the study. There may be a higher treatment burden for participants in this study compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, bone marrow biopsies, checking for side effects, and completing questionnaires.
未治療進展期小細胞肺癌患者におけるアテゾリズマブ＋カルボプラチン＋エトポシド（チラゴルマブ併用またはチラゴルマブ非併用）の併用試験
This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (\</= upper limit of normal \[ULN\] vs. \> ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase: * Arm A: Tiragolumab plus atezolizumab plus CE * Arm B: Placebo plus atezolizumab plus CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).
HERTHENA-Lung01：転移性または局所進行性EGFR変異非小細胞肺癌患者におけるパトリツマブ デルクステカン
This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.
進行性および再発性子宮内膜癌の一次治療後の維持療法としてのデュルバルマブとオラパリブの併用または併用療法
A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.
局所進行性または転移性非小細胞肺癌におけるアミバンタマブとラゼルチニブの併用療法とオシメルチニブの比較試験
The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
強直性脊椎炎および非放射線学的軸性脊椎関節炎を含む活動性軸性脊椎関節炎患者におけるビメキズマブの長期安全性、忍容性および有効性を評価する研究
The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).
日本におけるCOVID-19予防のためのAZD1222の研究
The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.
ブルトン型チロシンキナーゼ（BTK）阻害剤トレブルチニブ（SAR442168）の再発性多発性硬化症（RMS）研究（GEMINI 1）
Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
アルツハイマー病におけるアミロイドβ代謝へのブロモクリプチンの再利用
The goal of this clinical trial is to learn about safety and efficacy of bromocriptine in familial Alzheimer's disease with presenilin 1 mutations. The main questions it aims to answer are: •safety of bromocriptine •efficacy of bromocriptine Participants will answer questions, have blood exams, lumbar punctures and MRI/PET scans. Researchers will compare a participants group taking bromocriptine with a participants group taking placebo to see if there is any changes in cognitive function, and behavioral and psychiatric symptoms with dementia.
体格指数（BMI）が23～40 kg/m2の日本人男性におけるBI 456906の異なる投与量に対する忍容性を検証する研究
Main objectives are to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of different dose escalation schemes of BI 456906 in healthy Japanese male subject with BMI 23-40 kg/m2 and to determine a dose escalation scheme for future studies.
経口FXIa阻害剤BAY 2433334の適切な投与量に関する情報を収集し、心臓関連の合併症を引き起こす可能性のある不整脈（心房細動）患者における、非ビタミンK経口抗凝固薬（NOAC）であるアピキサバンとの安全性を比較する研究。
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works in patients with irregular heartbeat (atrial fibrillation) that can lead to blood clots, stroke and other heart-related complications. In addition researchers want to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with atrial fibrillation. This study is also done to learn how the drug in this study moves into, through and out of the body. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor. Apixaban, works by reducing the production of blood clotting factors in our body and thins the blood and is a so called non-vitamin K oral anticoagulant (NOAC). Thinning the blood can prevent you from blood clots which can cause a stroke.
原発性IgA腎症患者におけるLNP023の有効性と安全性に関する研究
The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.
日本における掌蹠膿疱症（PPP）の治療パターン、疾患負担、治療結果に関するレジストリ研究
The purpose of this study is to describe the treatment patterns of participants receiving systemic treatment for of palmoplantar pustulosis (PPP) in Japan.