治験一覧
8,963 件中 2161〜2180 件を表示
非ホジキンリンパ腫患者におけるVAY736の単剤療法および特定の抗腫瘍剤との併用療法の試験
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of VAY736 alone or in combination with other therapies in patients with NHL in a platform trial.
固形腫瘍を有する成人患者におけるASP1570単独投与、またはASP1570とペムブロリズマブ、標準治療のいずれか、あるいはその両方との併用投与に関する研究
免疫療法は、体の免疫システムと連携して様々ながんを治療します。白血球の一種であるT細胞と連携して、特定の腫瘍を標的とし、攻撃します。しかし、腫瘍によっては、時間の経過とともにT細胞による攻撃に抵抗性を示すことがあります。これは、T細胞に「オフ」信号を送ることで起こります。研究者たちは、T細胞を再びオンにする方法を模索しています。 治療薬が承認される前に、臨床試験を行う必要があります。この試験は、進行固形がんの成人患者におけるASP1570に関するより詳細な情報を提供します。ASP1570は単独で投与されるか、ペムブロリズマブと呼ばれる別の薬剤と併用されるか、標準的ながん治療と併用されるか、あるいはペムブロリズマブとペメトレキセドおよびカルボプラチンと呼ばれる他の薬剤と併用されます。 この研究の主な目的は以下の通りです。 * ASP1570の安全性を確認する * ASP1570の忍容性を確認する * ASP1570の適切な投与量を決定する この研究は、進行固形がんの成人患者を対象としています。腫瘍は、発生した部位以外で増殖している（局所進行切除不能）か、体の他の部位に転移している（転移性）患者です。標準治療後にがんが悪化するか、標準治療を受けることができません。研究に参加できる患者については、研究担当医が詳しいアドバイスを提供します。 この研究は2部構成です。 第1部では、進行固形がん患者に最適なASP1570の投与量を決定します。進行固形がん患者を小グループに分け、それぞれに低用量から高用量のASP1570を投与します。被験者には、ASP1570単独、ASP1570とペムブロリズマブの併用、ASP1570と標準的ながん治療の併用、またはASP1570とペムブロリズマブ、ペメトレキセド、カルボプラチンの併用が投与されます。治験薬は、患者のがんの種類によって異なります。ASP1570の投与量は異なりますが、各グループは同じ投与量を維持します。ペムブロリズマブの標準的な投与量は1つだけです。標準的ながん治療の投与量は、添付文書に記載されています。最初のグループは、ASP1570の最低投与量を投与した後、医学的問題がないか検査を受けます。最初のグループが最低投与量に耐えられる場合にのみ、次のグループはより高い投与量のASP1570を投与できます。これは、各グループで同様に続けられます。 各グループは、21日周期でASP1570の錠剤を1日1回または2回服用します。被験者は、治験薬への忍容性が認められない場合、がんが悪化した場合、または治験担当医が治療中止を決定しない限り、同じ用量でさらに治療サイクルを継続します。ペムブロリズマブによる治療も受けている被験者は、ASP1570の2サイクルおき（6週間に1回）の初日にペムブロリズマブを投与されます。標準的ながん治療（ASP1570を使用）を受けている被験者は、添付文書に記載されている通りに治療を受けます。 パート2では、進行固形がんの被験者からなる複数の小グループが、パート1で算出された最適な用量のASP1570を投与されます。投与量は、パート1で被験者が忍容できる最高用量を超えることはありません。ASP1570は21日サイクルで1日1回または1日2回投与されます。ペムブロリズマブは6週間に1回投与されます。その他の治験薬は、14日、21日、または28日サイクルで投与されます。サイクルの長さとその他の治験治療（ペムブロリズマブおよび標準的な癌治療の種類）は、患者の腫瘍の種類によって異なります。標準的な癌治療は、そのラベルに従って実施されます。すべてのグループは、治験治療に耐えられなくなるか、癌が悪化するか、または治験担当医が治療を中止すべきだと判断しない限り、ASP1570（ペムブロリズマブ単独、標準的な癌治療との併用、またはペムブロリズマブ、ペメトレキセド、カルボプラチンとの併用）による治療サイクルをさらに継続します。
特発性肺線維症患者におけるHZN-825の有効性、安全性および忍容性を評価する多施設共同試験
HZNP-HZN-825-303 (HARBOR) comprises of 2 parts. Part 1 (Core Phase) is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in participants with Idiopathic Pulmonary Fibrosis (IPF). Part 2 (Extension Phase) is an optional, open-label, repeat-dose, multicenter extension of the Core Phase. The trial will include up to an 8-week Screening Period and a 52-week Double-blind Treatment Period in the Core Phase and 52 weeks of open-label HZN-825 treatment in the Extension Phase. During the Core Phase, participants will be screened within 8 weeks prior to the baseline (Day 1) Visit. Approximately 135 participants who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or matching placebo orally for 52 weeks using the following 2 stratification factors: 1. Concomitant use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no 2. Forced vital capacity (FVC) % predicted at Baseline: ≥70% or \<70% Participants who complete the 52-week Double blind Treatment Period of the Core Phase of the trial will be invited to extend their participation in the 52-week Extension Phase of the trial.
再発性または難治性の多発性骨髄腫患者を対象としたJNJ-64407564の日本人被験者を対象とした試験
The purpose of this study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (MM) at the recommended Phase 2 dose (RP2D) identified in NCT03399799 study.
血友病A患者の外科手術におけるTAK-660の研究。
This study is about a factor VIII medicine called Adynovate (TAK-660) used during surgery for people with hemophilia A who have low blood levels of factor VIII. The aims of this study are as follows: * To check for side effects from TAK-660. * To check how well TAK-660 controls bleeding when used routinely during surgery and other invasive procedures such as tooth extractions. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. During the study, participants will receive infusions of TAK-660 during their hospital stay for surgery according to their clinic's standard practice. The study doctors will check for bleeds and side effects from TAK-660 from surgery until discharge.
日本の臨床現場におけるウステキヌマブ導入投与後の潰瘍性大腸炎の症状改善に関する研究
The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan.
マイコバクテリウム・アビウム複合体による非結核性抗酸菌性肺感染症患者におけるALIS（アミカシンリポソーム吸入懸濁液）の評価研究
この研究の主な目的は、13 か月目に参加者が報告した呼吸器症状に対する ALIS (アミカシン リポソーム吸入懸濁液) + 背景レジメン (アジスロマイシン \[AZI\] + エタンブトール \[ETH\]) の有効性を ELC (空リポソーム対照) + 背景レジメンと比較して評価することです。
加齢黄斑変性に伴う地図状萎縮患者におけるダニコパンの研究
This is a dose finding study designed to evaluate the efficacy, safety, and pharmacokinetics of danicopan in participants with GA secondary to AMD. The study consists of a Screening Period of up to 6 weeks, a 104-week masked Treatment Period, followed by a 30-day Follow-up after the last dose. This study will have 4 treatments arms: 100 milligrams (mg) twice daily (bid), 200 mg bid, 400 mg once daily (qd), and matching placebo.
軽度または中等度のCOVID-19に罹患した非入院の成人および青年参加者におけるRO7496998（AT-527）の効果を評価する研究
This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.
発作性群発頭痛患者におけるエプティネズマブの効果
The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)
GORE® VIABAHN® 人工関節の市販後調査研究（JPS 16-03）
This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.
過体重または肥満の人におけるセマグルチド錠の1日1回服用の効果を調査する研究調査（OASIS 1）
This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation. Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning In addition to taking the medicine, participants will have talks with study staff about: * healthy food choices * how to be more physically active * what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits. Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.
特定の固形腫瘍患者におけるMK-7684Aと他の抗癌剤の併用または非併用（MK-7684A-005）（KEYVIBE-005）
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.
ARDS（急性呼吸窮迫症候群）に対するNOA-001のパイロット臨床試験
The primary object of this clinical study is to investigate the efficacy and the safety of NOA-001 in patients with ARDS (ARDS caused by Non-COVID-19 or COVID-19).
リムパーザ膵臓がん 日本における製造販売後調査（PMS）
To collect and characterise the incidence of adverse events related to the safety specifications of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual post-marketing use of LYNPAZA.
虚血性心筋症に対するヒト（同種）iPS細胞由来心筋細胞シートの臨床試験
Targeting patients with severe ischemic cardiomyopathy, the purpose of this study is as follows: to confirm short-term efficacy by observing changes and transitions in cardiac function and clinical symptoms compared with each patient's baseline (before and after comparison) by human iPS cell-derived cardiomyocyte sheet transplantation, and to evaluate the safety and tolerability including the combined use of immunosuppressants.
進行固形悪性腫瘍患者におけるGEN1046の安全性と薬物動態
The primary objective of the study is to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and pharmacokinetics (PK) of acasunlimab (also known as GEN1046) administered as monotherapy or in combination with pembrolizumab in Japanese study participants with malignant solid tumors.
進行性中皮腫およびその他の固形腫瘍患者を対象としたIAG933の第I相試験
The purpose of this study is to characterize the safety and tolerability of IAG933 in patients with mesothelioma, NF2/LATS1/LATS2 mutated tumors and tumors with functional YAP/TAZ fusions and to identify the maximum tolerated dose and/or recommended dose.
NTRK遺伝子融合陽性進行性または再発性固形腫瘍、遺伝子の特定の変化によって引き起こされるまれな癌
Researchers want to learn more about the use of larotrectinib as a real-world treatment for tropomyosin receptor kinase fusion cancer, also called TRK fusion cancer. In people with TRK fusion cancer, a gene called neurotrophic TRK, (NTRK) joins or "fuses" with another gene. This creates a protein known as a fusion protein, which can cause cancer cells to grow. The study treatment, larotrectinib, is already available for doctors to prescribe to patients with TRK fusion cancer. Larotrectinib works by blocking TRK genes in cancer cells which helps stop the cancer from growing. In this study, the researchers want to learn more about the safety and effectiveness of larotrectinib in adults and children with advanced or recurrent TRK fusion cancer. This means that their cancer has spread from where it started to other areas of the body, or the cancer has come back after a period of time. To answer this question, the researchers will collect information from patients who are taking larotrectinib as prescribed by their doctors. The researchers will learn what adverse events the patients are having. An adverse event is any medical problem that a patient has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The study will include patients of all ages with TRK fusion cancer. In this study, there will be no required tests or visits to a study site. Instead, the researchers will collect information from: * the patients' medical records * interviews with the patients or their parents or guardians * the patients' visits to their doctor as part of their usual care The researchers will collect information about the adults for up to about 2 years and about the children for up to about 8 years.
慢性炎症性脱髄性多発根神経炎（CIDP）および多巣性運動神経障害（MMN）の日本人患者を対象としたTAK-771の試験
The main aim of the study is to check for side effects from TAK-771, and to check how well TAK-771 controls symptoms in Japanese participants with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) The participants will be treated with TAK-771 for 45 months as a maximum. There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug (every 2, 3, or 4 weeks).