治験一覧
8,963 件中 2941〜2960 件を表示
局所進行（手術不能）または転移性HR+/HER2-乳がんに対する治療としてのカピバセルチブ+フルベストラントとプラセボ+フルベストラントの比較
Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.
デュシェンヌ型筋ジストロフィー治療におけるPF-06939926の安全性と有効性を評価する研究
The study will evaluate the safety and efficacy of gene therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study with two thirds of participants assigned to gene therapy. The one third of participants who are randomized to the placebo arm will have an opportunity for treatment with gene therapy at the beginning of the second year.
メイヨーステージIIIa ALアミロイドーシス患者におけるCAEL-101の有効性と安全性を評価する研究（CARES）
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival, reduces cardiovascular related hospitalizations and it is safe and well tolerated in patients with stage IIIa AL amyloidosis.
抗コロナウイルス免疫グロブリン（ITAC）を用いたCOVID-19の入院治療
This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.
バリシチニブ（LY3009104）のNNS/CANDLE試験、SAVI試験、AGS試験の成人および小児日本人被験者における試験
The main purpose of this study is to evaluate the efficacy and safety of baricitinib in adult and pediatric Japanese participants with Nakajo-Nishimura Syndrome/chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature (NNS/CANDLE), STING-associated vasculopathy with onset during infancy (SAVI), and Aicardi-Goutières Syndrome (AGS).
メイヨーステージIIIb ALアミロイドーシス患者におけるCAEL-101の有効性と安全性を評価する研究（CARES）
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival, reduces cardiovascular related hospitalizations and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.
機能性消化不良の小児患者を対象としたZ-338の第III相臨床試験
The purpose of this study is to evaluate pharmacokinetics, efficacy and safety of Z-338 of pediatric patients with functional dyspepsia (FD). In Part 1, the pharmacokinetics and safety of single oral dose of Z-338 100 mg are evaluated. In Part 2, the efficacy and safety of Z-338 100 mg orally 3 times daily before meals are evaluated. Part 2 is comprised by the double-blind phase and the open-label phase. In the double-blind phase, subjects will take Z-338 or placebo for 28 days. In the open-label phase, all subjects will take Z-338 for 28 days.
COVID-19 DNAワクチン（AG0301-COVID19）の研究
This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult volunteers.
デュピクセント®を開始した喘息患者の登録
The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life. This includes characterization of: * Patient demographics (eg, gender, age, and race) * Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height) The secondary objectives of the study are: * To characterize real-world use patterns of DUPIXENT® for asthma * To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting * To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT® * To collect long-term safety data on study participants in the real-world setting
原発性IgA腎症患者におけるオープンラベルイプタコパン/LNP023の長期安全性および忍容性を評価するロールオーバー延長プログラム（REP）
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.
再発性または転移性頭頸部癌におけるモナリズマブ＋セツキシマブの有効性と安全性のプラセボ＋セツキシマブとの比較評価
This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer.
健康成人を対象としたTS-142の薬物相互作用試験（イトラコナゾール併用投与）
This is an open-label, single-center, single-sequence study to evaluate the concomitant effects of the potent CYP3A inhibitor itraconazole on the single-dose pharmakokinetics, safety and tolerability of oral TS-142 in healthy subjects.
ステージIIIの非小細胞肺癌（NSCLC）におけるペムブロリズマブと同時化学放射線療法、およびそれに続くペムブロリズマブ単独またはオラパリブ単独の併用療法の試験（MK-7339-012/KEYLYNK-012）
The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are: 1. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS) 2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS
プラチナ製剤による治療歴のある子宮頸がん患者に対するビントラフスプアルファ単剤療法
The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.
ルキソリチニブに対する反応が不十分な骨髄線維症患者におけるパルサクリシブとルキソリチニブの有効性と安全性を評価する（LIMBER-304）
The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy.
DS-1062aを用いた、治療可能なゲノム変異を有する進行性または転移性非小細胞肺癌を対象とした試験（TROPION-Lung05）
This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.
持続性心房細動に対するカテーテルアブレーションの戦略
The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF: 1. PV antral isolation alone (PVAI) 2. PV antral isolation plus ablation of drivers (PVAI+drivers) 3. PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.
メラノーマ患者におけるイマチニブメシル酸塩とペムブロリズマブの併用療法
This is an open-labelled single arm trial of pembrolizumab and imatinib mesylate in subjects with unresectable or metastatic KIT-mutant melanoma that are refractory to standard therapy. The phase Ib and II study will be conducted to evaluate the safety, tolerability and response rate data of this combination therapy. KIT-mutant tumors will be confirmed in previously biopsied tumors. This analysis will be done by next-generation sequencing.
中等度から重度の血友病A成人患者におけるPF-07055480/ジロクトコゲン フィテルパルボベック遺伝子治療の有効性と安全性を評価する研究
C3731003 is a pivotal Phase 3 study to evaluate the clinical efficacy and safety of a single IV infusion of PF-07055480 / giroctocogene fitelparvovec (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in adult male participants with moderately severe or severe hemophilia A (FVIII:C≤1%) for the study duration of 5 years. The study will enroll eligible participants who have been followed on routine prophylaxis with FVIII products in the Lead-In study C0371004.
マサチューセッツ総合病院と土浦協同病院の冠動脈画像診断共同研究
The purpose of this collaboration is to establish a multi-modality image database including coronary angiograms, optical coherence tomography (OCT), computed tomography angiograms (CTA) and cardiac magnetic resonance imaging (CMR) for future studies. The main goal of this collaboration is to create a resource to promote further understanding of the pathobiology of atherosclerosis through image analysis.