治験一覧
8,963 件中 4201〜4220 件を表示
IDH1遺伝子変異を有する神経膠腫患者におけるDS-1001bの研究
This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.
固形腫瘍および非ホジキンリンパ腫患者を対象とした、NIR178とPDR001の併用療法に関する第2相試験
The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.
過活動膀胱患者におけるONO-8577の研究
The objective of the study is to evaluate the efficacy and safety of ONO-8577 compared to combination of solifenacin succinate and mirabegron or placebo for overactive bladder
FMS様チロシンキナーゼ3（FLT3）変異を有する再発性または難治性の急性骨髄性白血病（AML）患者、あるいは微小残存病変（MRD）を伴う完全寛解（CR）のFLT3変異AML患者を対象としたギルテリチニブ（ASP2215）の拡大アクセス試験
The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission \[CR\], complete remission with incomplete hematologic recovery \[CRi\], complete remission with incomplete platelet recovery \[CRp\]) with MRD without access to comparable or alternative therapy.
転移性乳がん患者におけるオラパリブ単剤療法の臨床的有効性および安全性を検討する。
This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations.
片頭痛の予防治療におけるTEV-48125の皮下投与の長期安全性および忍容性
To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of TEV-48125 (at 225 mg once monthly \[except for a loading dose of 675 mg for CM patients\] or at 675 mg every 3 months) for the preventive treatment of Chronic Migraine and Episodic Migraine patients
重症血友病A（EXTEN-A）の治療歴のある成人患者を対象とした、組換え凝固因子VIII Fc - フォン・ヴィルブランド因子 - XTEN融合タンパク質（rFVIIIFc-VWF-XTEN）（BIVV001）の単回静脈内注射の安全性、忍容性、および薬物動態に関する研究
The primary purpose was to assess the safety and tolerability of a single intravenous (IV) administration of BIVV001 in adult previously treated patients (PTPs) with severe hemophilia A.
非小細胞肺癌（NSCLC）の第一選択治療におけるニボルマブとイピリムマブの化学療法との併用と化学療法単独との比較研究
The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease
SHP633-302を完了した短腸症候群の日本人小児を対象とした研究
The purpose of this clinical study is to evaluate the long-term safety and tolerability of teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who completed Study SHP633-302 (NCT02980666).
健康な日本人男女を対象としたASP8062の安全性および忍容性を評価するための研究
The purpose of this study is to evaluate the safety and tolerability and evaluate pharmacokinetics of single and multiple ascending oral doses of ASP8062 in nonelderly Japanese male and female subjects.
再発性および／または難治性多発性骨髄腫患者を対象とした、イサツキシマブ、カルフィルゾミブ、デキサメタゾン併用療法とカルフィルゾミブ、デキサメタゾン併用療法を比較する多国籍臨床試験
The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of therapy.
日本人喘息患者を対象としたフルチカゾンフランカルボン酸エステル／ウメクリジニウム臭化物／ビランテロールトリフェナテート配合剤の長期安全性試験
Despite availability of treatments and published guidelines, subjects may have asthma that is inadequately controlled. GlaxoSmithKline is currently developing a once-daily 'closed' triple therapy of an Inhaled Corticosteroids/Long-Acting Beta-2-Agonists/Long-Acting Muscarinic Antagonist (ICS/LAMA/LABA) combination (Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate \[FF/UMEC/VI\]) in a single device, with the aim of providing a new treatment option for the management of asthma by improving lung function, health-related quality of life (HRQoL) and symptom control over established combination therapies. This study has 3 study periods: Run-in, Treatment period and a Follow-up period. Eligible subjects who meet the pre-defined criteria at screening (Visit 1) will enter into a 2-week run-in period. Subjects will continue their pre-screening inhaled medications for asthma (ICS+LABA or ICS+LABA+LAMA) without any change in regimen/dosage until day before Visit 2. At Visit 2 subjects will be allocated to either FF/UMEC/VI 100/62.5/25 or FF/UMEC/VI 200/62.5/25 micrograms (mcg) treatment depending on the asthma control status for 52 weeks. Switching medication from FF/UMEC/VI 100/62.5/25 to FF/UMEC/VI 200/62.5/25 will be permitted in accordance with the control status of the subject assessed by Asthma Control Questionnaire (ACQ)-7 at Week 24 of the treatment period. A follow-up visit will be conducted for approximately 1 week. Subjects will be provided with salbutamol as a rescue medication throughout the study.
OBP-301とペムブロリズマブの特別な組み合わせ
This is multicenter, open-label Phase I study to exploratively evaluate the efficacy and safety of OBP-301 in combination with Pembrolizumab in patients with advanced solid tumors.
腎摘出術後に転移を発症するリスクが高い腎細胞癌（RCC）患者を対象とした、アテゾリズマブの補助療法としての効果に関する研究
This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.
「ヘリコバクター・ピロリ除菌補助薬」としてのタケカブの薬物使用状況の監視
The purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (Takecab) tablets (triple therapy) in the routine clinical setting.
グラム陰性病原体による院内肺炎の治療におけるセフィデロコル（S-649266）の臨床試験
The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative pathogens.
COPDを有する日本人被験者におけるPT010、PT003、およびPT009の安全性および有効性をSymbicort® Turbohaler®と比較評価する研究
A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®
肝硬変患者におけるADR-001の研究
This is a first-in-human Phase1/2 study of ADR-001, adipose-derived mesenchymal stem cells (AD-MSCs). The safety and preliminary efficacy are evaluated in Phase 1 in patients with liver cirrhosis caused by Hepatitis C or Nonalcoholic Steatohepatitis and a recommended Phase 2 dose is determined by the evaluation. The exploratory efficacy and safety are investigated against the same target population in Phase 2.
進行性核上性麻痺患者におけるBIIB092の臨床試験
The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 \& 4 laboratory abnormalities. The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.
中等度から重度のアトピー性皮膚炎患者におけるバリシチニブ（LY3009104）の研究
The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.