治験一覧
8,963 件中 3761〜3780 件を表示
経口抗凝固薬の安全性と有効性の評価
This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment
血栓性血小板減少性紫斑病（TTP）を持って生まれた小児、10代、成人を対象としたBAX 930の研究
Thrombotic thrombocytopenic purpura (or TTP for short) is a condition where blood clots form in small blood vessels throughout the body. The clots can limit or block the flow of oxygen-rich blood to the body's organs, such as the brain, kidneys, and heart. As a result, serious health problems can develop. The increased clotting that occurs in TTP uses up the cells that help the blood to clot, called platelets. With fewer platelets available in the blood, bleeding problems can occur. People who have TTP may bleed underneath the skin forming purple bruises or purpura, or from the surface of the skin. TTP also can cause anemia, a condition in which red blood cells break apart faster than the body can replace them leading to lower than normal number of red blood cells. A lack of activity in the ADAMTS13 enzyme, a protein in the blood involved in blood clotting, causes TTP. The enzyme breaks up another blood protein called von Willebrand factor that clumps together with platelets to form blood clots. Some people are born with this condition, others get the condition during their life. Many people who born with TTP experience frequent flareups that need to be treated right away. If not treated It can be fatal or cause lasting damage, such as brain damage or a stroke. BAX 930 is a medicine that replaces ADAMTS13 and can prevent or control TTP flareups, called TTP events. The main aim of this study is to compare the number of TTP events in people born with severe TTP when they treated with BAX 930 versus when they are treated with the standard treatment. Treatment will be given in 2 ways: * BAX 930 or standard treatment given to prevent TTP events from happening. * BAX 930 or standard treatment given to control an acute TTP event when it happens, according to the clinic's standard practice. Both BAX 930 and standard treatment are given slowly through a vein (infusion). At the first visit, the study doctor will check if you can participate in the study. If you are eligible and enter the study, you will follow an assigned schedule and either start with BAX 930 (Period 1) and then switch to standard treatment (Period 2) or start with standard treatment (Period 1) and then switch to BAX 930 (Period 2). Everyone will be treated with BAX 930 again for Period 3. Each Period will last approximately 6 months. If you enter the study to control an acute TTP event, you will follow a schedule receiving either BAX 930 or standard care to treat your acute TTP event. Once the acute TTP event has gotten better, you can decide to continue in the study and be given treatment to prevent TTP events from happening, following the schedule above. Another study's aim is to assess side effects from treatment with BAX 930 and standard treatment. To do that, the study doctor will ask you questions about your health at each study visit. The study doctors will also check how long BAX 930 stays in the blood of the participants, over time. They will do this from blood samples taken after participants receive their specific infusions of BAX 930. This will happen at different times during the study. 1 month after all treatment has been completed, participants will visit the clinic for a final check-up.
胃癌／胃食道接合部癌におけるベマリツズマブ（FPA144）と改変FOLFOX6（mFOLFOX6）の併用療法に関する研究
The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer.
切除不能ステージIII非小細胞肺癌患者における化学放射線療法後のオシメルチニブの効果を評価する国際共同研究（LAURA）
A global study to assess the efficacy and safety of osimertinib following chemoradiation in patients with stage III unresectable Epidermal Growth Factor Receptor Mutation Positive non-small cell lung cancer
同時化学放射線療法後に病勢進行が認められなかった限局期小細胞肺癌患者を対象としたデュルバルマブ＋トレメリムマブ、デュルバルマブ、プラセボの試験
This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy
この研究は健康な日本人ボランティアを対象に実施され、BI 1015550の異なる用量が体内にどのように吸収され、どの程度忍容性があるかを調べます。
The primary objective of this trial is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality of BI 1015550 after single dosing.
中等度から重度の活動性潰瘍性大腸炎患者を対象としたミリキズマブの維持試験
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).
IPMN患者における術中膵鏡検査
To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent randomized control trial.
早期HER2陽性乳がんにおける、術前ドキソルビシン＋シクロホスファミド療法に続いてパクリタキセル＋トラスツズマブ＋ペルツズマブ療法を行う際の、アテゾリズマブまたはプラセボ併用療法の有効性および安全性を評価する研究
This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).
Javelin BRCA/ATM：BRCAまたはATM遺伝子変異を有する固形腫瘍患者におけるアベルマブとタラゾパリブの併用療法
Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.
喘息患者を対象に、AZD7594を1日1回吸入投与した場合の、複数の投与量レベルにおける有効性および安全性を評価する研究
This study will assess the efficacy and safety of multiple dose levels of AZD7594 administered once daily (QD) by inhalation in a 12-week treatment period on asthma subjects. The activity will be assessed by comparing AZD7594 to placebo. The comparison between active comparator (FF) and placebo will be used for bench marking. The efficacy is assessed by the evaluation of change in trough forced expiratory volume in 1 second (FEV1). The aim is to develop AZD7594 as a once daily inhaled non-steroidal selective GR modulator (SGRM), which may ultimately lead to better disease control of both chronic obstructive pulmonary disease (COPD) and asthma through improved efficacy and compliance. The overall rationale for developing a once daily AZD7594 in a dry powder inhaler (DPI) is to provide a safe and effective future treatment option for both asthma and COPD subjects.
深在性真菌症の治療におけるAK1820（イサブコナゾニウム硫酸塩）の臨床試験
The objective of this study is to investigate the safety and efficacy of administering 372.6 mg of AK1820 (isavuconazonium sulfate) intravenously or orally to adult Japanese patients with deep mycosis. The primary endpoint is safety (percentage of patients with adverse events after starting the study treatment).
アクリソフIQトーリックAコード市販後臨床試験
The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.
切除不能尿路上皮癌患者における化学療法と併用したデュルバルマブ、化学療法と併用したトレメリムマブとの併用、または化学療法に関する研究
これは、尿路上皮（腎盂、尿管、膀胱、尿道を含む）の組織学的または細胞学的に診断された切除不能な局所進行または転移性移行上皮癌患者を対象に、第一選択化学療法として、デュルバルマブ±トレメリムマブと標準治療（SoC）化学療法（シスプラチン＋ゲムシタビンまたはカルボプラチン＋ゲムシタビンの2剤併用）の併用と、それに続くデュルバルマブ単独療法とSoC単独療法の有効性と安全性を判断するための、ランダム化、非盲検、対照、多施設、国際共同第III相試験です。
レノックス・ガストー症候群の小児および成人における補助療法としてのZX008（フェンフルラミン塩酸塩）の有効性と安全性を調査する研究
This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).
MO治療におけるパロバロテンの有効性および安全性に関する研究
This is a randomized, double-blind, placebo-controlled study comparing the safety and efficacy of 2 dosage regimens of palovarotene versus placebo in preventing disease progression in pediatric subjects with multiple osteochondromas (MO).
再発性および難治性多発性骨髄腫患者におけるbb2121の有効性および安全性試験
This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
LenSx®とCenturion®の併用によるFLACSの臨床評価
The purpose of this study is to evaluate cumulative dissipated energy (CDE), endothelial cell loss, and average torsional amplitude with combination of LenSx® and Centurion® compared to conventional cataract surgery.
アジアのパートナーとの共同研究によるX連鎖性低リン血症性くる病/骨軟化症患者の長期観察研究
Through observation of patients with X-linked hypophosphatemic rickets/osteomalacia (XLH) for up to 10 years, the study intends to collect data that allow achievement of the following objectives: 1. To determine medical characteristics of the disease and the disease process 2. To determine physical and psychological burden on patients as well as economic burden 3. To assess the efficacy and safety of the treatment of the disease
進行肝細胞癌患者におけるレンバチニブ（E7080/MK-7902）とペムブロリズマブ（MK-3475）の併用療法とレンバチニブ単独療法の安全性および有効性（MK-7902-002/E7080-G000-311/LEAP-002）
The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).