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IDH1変異を有する進行性固形腫瘍におけるBAY1436032の第I相臨床試験

完了NCT02746081第1相

The primary objective of this study is: \- Determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of BAY 1436032 in patients with isocitrate dehydrogenase-1 (IDH1)-R132X-mutant advanced solid tumors. The secondary objectives of this study are: * Evaluate the pharmacokinetics (PK) of BAY1436032 in patients with IDH1-R132X-mutant advanced solid tumors. * Evaluate the effect of a standard high-fat, high calorie meal on the PK of BAY1436032. * Assess pharmacodynamic (PD) effects and evidence of clinical efficacy associated with BAY1436032 administration in patients with IDH1-R132X-mutant advanced solid tumors.

対象疾患:
Solid Tumors

血友病Aおよび第VIII因子(FVIII)阻害因子を有する小児患者におけるエミシズマブの皮下投与に関する研究

完了NCT02795767第3相

This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This study will open two additional non-randomized cohorts to investigate once every 2 weeks (Q2W) and once every 4 weeks (Q4W) regimens in pediatric participants.

対象疾患:
Hemophilia A

再発性または難治性の末梢性T細胞リンパ腫(PTCL)患者を対象としたSP-02Lの第2相臨床試験

完了NCT02653976第2相

This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory patients with peripheral T-cell lymphoma.

対象疾患:
Peripheral T-Cell Lymphoma

エロツズマブを研究する以前のプロトコルに参加した参加者に対する治療の継続

実施中(募集終了)NCT02719613第2相

The purpose of this study is to continue to provide elotuzumab and/or other study drugs to participants who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply.

対象疾患:
Multiple Myeloma

食事療法と運動療法のみで治療された2型糖尿病患者における経口セマグルチドとプラセボの有効性および安全性

完了NCT02906930第3相

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise only.

対象疾患:
DiabetesDiabetes Mellitus, Type 2

非放射線学的軸性脊椎関節炎患者を対象としたイキセキズマブ(LY2439821)の研究

完了NCT02757352第3相

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).

対象疾患:
Axial Spondyloarthritis

ASP8825 - 腎機能障害および血液透析を受けている患者における薬物動態試験

完了NCT02629224第1相

The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.

対象疾患:
Patients With Impaired Renal Function and Haemodialysis

血流依存性血管拡張法による高脂血症患者の血管内皮機能に対するオメガ3脂肪酸エチルエステル(TAK-085)の効果に関する探索的研究

完了NCT02824432第4相

The purpose of this study is to explore the effects of omega-3-acid ethyl esters (TAK-085) on vascular endothelial function when administered for 8 weeks, as measured by FMD, in patients with hyperlipidemia.

対象疾患:
Hyperlipidemia

BBI608とペムブロリズマブの特別な組み合わせ

中止NCT02851004第1/第2相

the efficacy and safety of BBI608 in combination with pembrolizumab

対象疾患:
Metastatic Colorectal Cancer

原発性シェーグレン症候群(pSS)患者におけるVAY736の安全性および有効性

完了NCT02962895第2相

The purpose of this study was to determine the dose-response relationship of VAY736 for key efficacy and safety parameters

対象疾患:
Primary Sjogren Syndrome

プラセボと比較した際の、研究薬プラルエント(アリロクマブ)の神経認知機能への影響の評価

完了NCT02957682第4相

The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.

対象疾患:
Hypercholesterolemia

トランスサイレチン心筋症患者におけるタファミジスの長期安全性

完了NCT02791230第3相

Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy

対象疾患:
Transthyretin (TTR) Amyloid Cardiomyopathy

オメガ3脂肪酸エチルエステルが血液中の脂質およびリポタンパク質プロファイルに及ぼす影響に関する探索的研究

完了NCT02839902第4相

The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receiving a HMG-CoA reductase inhibitor by use of HPLC in comparison with the control group of patients not treated with omega-3-acid ethyl esters.

対象疾患:
Hyperlipidemia

活動性原発性シェーグレン症候群の成人患者におけるアバタセプトの有効性および安全性を評価する研究

完了NCT02915159第3相

The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.

対象疾患:
Sjogrens Disease

非アルコール性脂肪性肝炎(NASH)患者におけるトロピフェキサー(LJN452)の安全性および有効性に関する研究

中止NCT02855164第2相

The purpose of the study was to assess the effects of different doses of tropifexor (LJN452) with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

対象疾患:
Non-alcoholic Steatohepatitis (NASH)

閉塞性肺疾患の観察研究(新規性)

完了NCT02760329

The NOVEL Observational longiTudinal studY (NOVELTY) is an observational study of obstructive lung disease and is a multi-country, multi-centre, prospective, longitudinal cohort study which will recruit patients with a diagnosis, or suspected diagnosis, of asthma and/or Chronic Obstructive Pulmonary Disease (COPD). Patients will undergo clinical assessments and receive standard medical care as determined by their treating physician. Patients enrolled in NOVELTY will be followed up yearly by their treating physician for a total duration of three years. In addition, patients will be followed up remotely every 3 months. The NOVELTY study will collect data currently lacking to allow for multinational data collection to fill regional/local gaps and improve comparability across regions.

対象疾患:
AsthmaCOPDChronic Obstructive Pulmonary Disease

新規にFLT3-ITD陽性と診断された急性骨髄性白血病(AML)患者における、標準治療化学療法との併用および継続療法としてのクイザルチニブ

完了NCT02668653第3相

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

対象疾患:
Acute Myeloid LeukemiaLeukemia

進行性/再発性非扁平上皮非小細胞肺癌患者におけるFKB238とアバスチンの評価

完了NCT02810457第3相

The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer

対象疾患:
Carcinoma, Non-Small-Cell Lung

鉄欠乏性貧血に対する静脈内鉄剤の有効性に関する研究

完了NCT02731534第3相

The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with Iron-deficiency Anemia (IDA)

対象疾患:
Iron Deficiency Anemia

リンパ腫または慢性リンパ性白血病患者におけるデュルバルマブの単剤療法および併用療法における投与量、安全性、および有効性を決定するための研究

完了NCT02733042第1/第2相

This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL).

対象疾患:
Leukemia, Lymphocytic, Chronic, B-CellLymphoma