治験一覧
8,963 件中 2801〜2820 件を表示
ACS患者におけるPCI施行時の意思決定に対するOCTイメージングの影響
Optical coherence tomography (OCT) provides valuable information to guide percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) regarding lesion preparation, stent sizing, and stent optimization.
再発性子宮頸がん患者におけるペムブロリズマブとオラパリブの併用療法
This trial is a multicenter, single-arm, phase 2 study of pembrolizumab in combination with olaparib in recurrent or metastatic cervical cancer patients who had disease progression during or after platinum-based chemotherapy.
好酸球性食道炎患者におけるベンラリズマブの研究
The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment period and a 28-week open-label treatment period). It is proposed that benralizumab will deplete eosinophils from GI tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity. Upon completion of the initial 52-week treatment period, patients will be offered an additional Open Label Extension period of at least 1 year, with benralizumab treatment and ongoing study assessments.
65歳以上の日本人2型糖尿病患者におけるエンパグリフロジンの有効性を検証する研究
This study is to assess the efficacy of empagliflozin 10 mg after 52 weeks compared to placebo in elderly patients with Type 2 diabetes mellitus (T2DM) and to explore if empagliflozin has any impact on patient physical condition compared to placebo in elderly patients with T2DM.
健康な日本人男性を対象とした、BI 894416の様々な投与量に対する忍容性を検証する研究
The objective of this trial is to investigate the safety, tolerability and pharmacokinetics of BI 894416 in healthy Japanese male subjects.
高血圧症の2歳以上6歳未満の小児におけるTAK-536の臨床試験
The main aim of this study is to check the safety of TAK-536. This study will take place in Japan. At the first visit, the study doctor will check if each child can take part. For those who can take part, each participant will have a check-up by the study doctor. After this, each participant will take placebo. This might take 2 weeks. After this, parents or the caregivers of each participant will be given sachets that contain granules of TAK-536 to give to that participant. The participants will take the TAK-536 granules once a day for 52 weeks. After treatment has finished, participants will visit the study clinic for a final check-up.
新規診断された高リスク骨髄異形成症候群の成人患者における疾患活動性の変化を評価するためのベネトクラックス錠と静脈内または皮下アザシチジンの併用試験
Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS. Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.
再発性／難治性多発性骨髄腫におけるベランタマブ・マフォドチン＋ポマリドミド＋デキサメタゾン（Pd）とボルテゾミブ＋Pdの比較
This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).
健康成人を対象としたエダラボンの経口懸濁液および静脈内製剤の生物学的同等性試験
To evaluate the single-dose bioequivalence of oral suspension and intravenous (IV) formulation of edaravone in the fasting state in healthy adult subjects
自己免疫性肺胞蛋白症（aPAP）におけるモルグラモスチム吸入ネブライザー溶液の臨床試験
160 subjects with autoimmune pulmonary alveolar proteinosis (aPAP) will be randomized to receive once daily treatment with inhaled molgramostim (MOL) or placebo (PBO) for 48 weeks. Subjects completing the 48-week placebo-controlled period will receive open-label treatment with once daily inhaled molgramostim for 96 weeks.
造血幹細胞移植後の血栓性細小血管症に対するラブリズマブ
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab in adult and adolescent participants with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In Stage 1, an open-label, single-arm period, the dosing regimen will be confirmed. In Stage 2, participants will be randomized to receive either blinded ravulizumab plus best supportive care or matching placebo plus best supportive care. The treatment period is 26 weeks (open-label for Stage 1, and randomized, double-blind, and placebo-controlled for Stage 2) followed by a 26-week follow-up period.
線維芽細胞増殖因子受容体（FGFR）2遺伝子融合を有する切除不能進行性または転移性胆管癌患者を対象としたE7090の試験
The primary purpose of the study is to assess the objective response rate (ORR) of E7090 by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 based on independent imaging review (IIR) in participants with unresectable cholangiocarcinoma with FGFR2 gene fusion who failed gemcitabine-based combination chemotherapy.
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).
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.
R/RおよびMRD+B-ALL患者におけるブリナツモマブ皮下投与の研究
The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. The Phase II part of the study will evaluate the safety, efficacy, and tolerability of SC blinatumomab for treatment of R/R B-ALL and Minimum Residual Disease Positive (MRD+) B-ALL in participants 12 years old and greater. It will also conduct a clinical pharmacokinetic (PK) evaluation of SC1 and SC2 blinatumomab formulations.
BCG反応の予測
To date, there are no diagnostics capable of predicting treatment response to intravesical BCG. Because of this severe limitation, nearly 50% of patients treated with BCG fail therapy and will a) require additional intravesical therapy or b) require cystectomy. A urine-based diagnostic that possesses the potential to accurately identify patients who will respond favorably to intravesical BCG is desperately needed.
ウイルス学的抑制状態にあるヒト免疫不全ウイルス（HIV）-1感染者を対象に、カボテグラビル（CAB）長時間作用型（LA）製剤とリルピビリン（RPV）長時間作用型製剤の併用療法とBIKTARVY®（BIK）製剤の有効性および安全性を評価する研究
This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.
持続性または慢性の免疫性血小板減少症（ITP）の成人および青年におけるリルザブルチニブの評価研究
This is a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of \<30,000/μL (and no single platelet count \>35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients will receive rilzabrutinib or placebo 400mg twice daily. For each patient, the study will last up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This includes Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. Followed by a 4-week post dose follow-up. For adult participants, the maximum duration of the long-term extension (LTE) period will be 12 months from the date of the last adult participant to enter the LTE. For pediatric participants, the maximum duration of the LTE period will be 12 months from the date of the last pediatric participant to enter the LTE.
c-MET陽性非小細胞肺癌患者におけるグルメチニブの抗腫瘍効果および安全性の評価
Indication:Patients with Advanced c-MET-positive Non-Small Cell Lung Cancer Phase Ib (China only): Approximately 90 patients Phase Ⅱ (globally): Approximately 78 evaluable patients; addition of at least 6 patients in Safety Run-in (US only)
タブレクタ錠の特定使用成績調査
This study was an uncontrolled, primary data collection-based observational study to be conducted as a central registration system, multicenter special drug-use results surveillance. As an all-case study, this study collected all patients treated with Tabrecta in a specified post-marketing period. The observation period of each patient was up to 1 year (52 weeks)