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吸収GT1ジャパンPMS

完了NCT03409731該当なし

The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.

対象疾患:
Angina PectorisCoronary Artery DiseaseCoronary Artery OcclusionIschemic Heart DiseaseMyocardial Ischemia

脳腫瘍患者における放射線療法と併用したAZD1390の安全性と忍容性を評価する研究

募集中NCT03423628第1相

This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to patients. This study will test safety, tolerability and PK (how the drug is absorbed, distributed and eliminated) of ascending doses of AZD1390 in combination with distinct regimens of radiation therapy

対象疾患:
Brain Neoplasms, MalignantLeptomeningeal Disease (LMD)Primary Glioblastoma MultiformeRecurrent Glioblastoma Multiforme

大うつ病性障害患者におけるブレクスピプラゾールの研究

完了NCT03697603第2/第3相

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.

対象疾患:
Major Depressive Disorder

日本人2型糖尿病患者におけるトラディアンスの副作用に関する長期研究

完了NCT03761797

Study objectives is to investigate the safety of long-term daily use of TRADIANCE® Combination Tablets AP and BP in Japanese patients with Type 2 Diabetes mellitus (T2DM) used in routine care.

対象疾患:
Diabetes Mellitus, Type 2

大うつ病性障害(MDD)患者における再発予防のためのラパスチネル単剤療法の研究

中止NCT03614156第3相

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (MDD).

対象疾患:
Depressive Disorder, Major

ホルモン受容体陽性HER2陰性の再発性または転移性乳がん患者における抗PD-L1抗体+抗CTLA-4抗体とホルモン療法の併用療法

中止NCT03430466第2相

The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer.

対象疾患:
Breast Cancer

特発性肺線維症(IPF)患者を対象に、標準治療と併用した場合のGLPG1690の有効性と安全性を検証する臨床試験

中止NCT03711162第3相

The main purpose of this study was to see how GLPG1690 works together with your current standard treatment on your lung function and IPF disease in general. The study also investigated how well GLPG1690 is tolerated (for example if you got any side effects while on study drug).

対象疾患:
Idiopathic Pulmonary Fibrosis

テリソツズマブ ベドチン(ABBV-399)の既治療c-Met陽性非小細胞肺癌患者を対象とした試験

実施中(募集終了)NCT03539536第2相

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).

対象疾患:
Non-small Cell Lung Cancer

非アルコール性脂肪性肝疾患(NAFLD)患者におけるペマフィブラートの研究

完了NCT03350165第2相

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease.

対象疾患:
Non-Alcoholic Fatty Liver Disease

HER2陰性転移性乳がん患者における抗PD-1抗体と放射線療法の併用

完了NCT03430479第1/第2相

The aim of this study is to evaluate the safety and efficacy of anti PD-1 antibody with radiation therapy in patients with HER2-negative metastatic breast cancer.

対象疾患:
Breast Cancer

アスピリンとクロピドグレルを服用している患者における脳卒中予防のためのBMS-986177に関する研究

完了NCT03766581第2相

The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.

対象疾患:
Acute Ischemic StrokeTransient Ischemic Attack (TIA)

転移性大腸癌におけるオキサリプラチン誘発性末梢神経障害の予防的治療(POLAR-M)

中止NCT03654729第3相

This study evaluates the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin.

対象疾患:
Chemotherapy-induced Peripheral NeuropathyColorectal Cancer

進行卵巣がん患者におけるデュルバルマブと化学療法およびベバシズマブの併用療法、それに続くデュルバルマブ、ベバシズマブ、オラパリブによる維持療法

実施中(募集終了)NCT03737643第3相

This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.

対象疾患:
Advanced Ovarian Cancer

プログラム細胞死リガンド1(PD-L1)発現進行非小細胞肺癌(NSCLC)患者における第一選択(1L)治療としてのM7824とペムブロリズマブの比較

完了NCT03631706第3相

The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.

対象疾患:
Non-small Cell Lung Cancer

テリパラチド投与期間がデノスマブ療法前の骨代謝および骨密度に及ぼす影響の検討

不明NCT03702140第2相

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in osteoporosis patients: 1. The administration period of teriparatide is less than 6 months and thereafter, denosumab for 24 months. 2. The administration period of teriparatide is from 6 to 12 months and thereafter, denosumab for 24 months. 3. The administration period of teriparatide is more than 12 months and thereafter, denosumab for 24 months.

対象疾患:
Osteoporosis

略称:AJCC/UICC v.8ステージII-IIIAおよびIIIB(T>5cm N2)の完全切除された非小細胞肺癌成人患者における補助療法としてのカナキヌマブの有効性および安全性に関する研究 略称:CANOPY-A

中止NCT03447769第3相

The primary purpose of the study was to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages II -IIIA according to the 8th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) and the subset of IIIB (T\>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).

対象疾患:
Non-Small Cell Lung Cancer

テノホビルアラフェナミド(TAF)を用いた逐次療法を受けた慢性B型肝炎患者の治療成績

完了NCT03471624第4相

Primary Objective: To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV (hepatitis B virus) treatment

対象疾患:
Hepatitis B, Chronic

日本人6歳から64歳を対象とした13価肺炎球菌結合型ワクチンの安全性および免疫原性に関する研究

完了NCT03571607第3相

This study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines.

対象疾患:
Pneumococcal Infections

切除不能肝細胞癌患者の実臨床における全生存率

募集中NCT03612726

Liver cancer is the fifth most common cancer and the second most frequent cause of cancer-related death globally. Hepatocellular carcinoma represents about 90% of primary liver cancers and constitutes a major global health problem. The pattern of HCC occurrence shows a significant geographical imbalance, with the highest incidence rates in East Asia (more than 50% of the cases occurring in China). The aim of this study is to investigate the overall survival (OS) of patients diagnosed with unresectable hepatocellular carcinoma under real-world practice conditions in Asia Pacific region.

対象疾患:
Hepatocellular Carcinoma

SK-1403長期治療試験;血液透析を受けている二次性副甲状腺機能亢進症患者における長期試験

完了NCT03626948第3相

To evaluate the safety and efficacy of treatment with SK-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.

対象疾患:
Secondary Hyperparathyroidism