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CARDIO-TTRansform:トランスサイレチン介在性アミロイド心筋症(ATTR CM)患者におけるエプロンテルセン(旧称ION-682884、IONIS-TTR-LRx、AKCEA-TTR-LRx)の有効性と安全性を評価する試験

実施中(募集終了)NCT04136171第3相

To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM receiving available standard of care (SoC).

対象疾患:
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

登録前にダロルタミドによる治療が決定された非転移性去勢抵抗性前立腺癌(nmCRPC)患者を観察し、特定の転帰を記述する研究

実施中(募集終了)NCT04122976

The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice.

対象疾患:
Prostate Cancer

化学療法が適応とならないAML患者におけるアザシチジンおよびベネトクラックスとの併用によるMBG453の試験

中止NCT04150029第2相

This trial seeked to extend the preliminary findings of efficacy by evaluating MBG453 in combination with hypomethylating agents (HMA) and also Bcl-2 inhibitor venetoclax.

対象疾患:
Acute Myeloid Leukemia

再発性または難治性成人T細胞白血病/リンパ腫を対象としたバレメトスタットトシル酸塩(DS-3201b)の第2相試験

完了NCT04102150第2相

This Phase 2 study will be conducted to assess the efficacy and safety of valemetostat tosylate (DS-3201b) in participants with relapsed or refractory adult T-cell leukemia/lymphoma (r/r ATL).

対象疾患:
Adult T-cell Leukemia/Lymphoma

活動性ループス腎炎患者における、標準治療(SoC)との併用におけるセクキヌマブとプラセボの安全性、有効性および忍容性の比較試験

中止NCT04181762第3相

This was a pivotal, randomized, double-blind, placebo-controlled trial evaluating at Week 52 the efficacy and safety of secukinumab versus placebo in patients with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features) also receiving background standard of care therapy (SoC).

対象疾患:
Lupus Nephritis

低リスク骨髄異形成症候群患者を対象としたASTX727の第1相試験

実施中(募集終了)NCT03906695第1相

To investigate the tolerability and safety of ASTX727 in Japanese subjects with lower-risk MDS.

対象疾患:
Lower-risk Myelodysplastic

経皮的電気神経刺激が膝変形性関節症(OA)および/または慢性疼痛患者に及ぼす影響

不明NCT04084236該当なし

The purpose of this study is to evaluate the effect of TENS at the knee pain.

対象疾患:
Knee Pain

インスリン グラルギン(メトホルミン併用または非併用)で血糖コントロールが不十分な2型糖尿病患者を対象とした、ティルゼパチド(LY3298176)とプラセボの比較試験

完了NCT04039503第3相

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.

対象疾患:
Type 2 Diabetes

脳卒中後うつ病に対するiPadアプリケーションを用いた介入

不明NCT03864484該当なし

We plan to conduct a randomized controlled trial to examine whether usual rehabilitation plus an iPad application-based intervention improves post-stroke depression symptoms compared to usual rehabilitation alone. The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.

対象疾患:
Post-stroke Depression

持続性または慢性の原発性免疫血小板減少症(ITP)の成人被験者におけるロザノリキシズマブの有効性、安全性および忍容性を評価する試験

中止NCT04200456第3相

The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).

対象疾患:
Primary Immune Thrombocytopenia

トラスツズマブBSの安全性と有効性

完了NCT04181333

To confirm the safety and efficacy of this drug under the actual use

対象疾患:
Gastric Cancer

全身性エリテマトーデス(SLE)の小児患者を対象とした皮下(SC)ベリムマブの試験

実施中(募集終了)NCT04179032第2相

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to 17 years of age with SLE on a background of standard of care therapy. This bridging PK study is part of an extrapolation strategy to support the use of SC belimumab in pediatric SLE participants, based on the completed adult SLE study with SC belimumab and the pediatric SLE study with intravenous (IV) belimumab. Part A is an open label 12-week treatment phase where participants will be enrolled and allocated to treatment cohorts based on their body weight at baseline. The dose and dosing regimens selected for SC administration in this pediatric population are intended to achieve a similar average exposure as observed with the weekly 200 mg SC dosing regimen in adult SLE patients. Part B is an optional 40-week open-label continuation phase, open to all participants who have completed Part A. Dosing of SC belimumab may continue at the same frequency in Part B or may require a change in frequency according to changes in participant body weight. The total duration of the study will be 68 weeks including a 12-Week open label treatment phase (Part A), an optional 40-week open-label continuation phase (Part B) and 16-week follow-up.

対象疾患:
Systemic Lupus Erythematosus

肥満または過体重の参加者におけるティルゼパタイド(LY3298176)の研究

完了NCT04184622第3相

This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

対象疾患:
ObesityOverweight

冠動脈造影およびインターベンションにおける遠位橈骨動脈アプローチと従来型橈骨動脈アプローチの比較

完了NCT04171570該当なし

The objective of this study is to demonstrate the superiority of Distal Radial Access (DTRA) to Conventional Transradial Access (CTRA) regarding forearm radial artery occlusion (RAO). This trial plans to include 1300 patients in around 12 locations around the world (11 participating sites in Europe and 1 participating site in Japan).

対象疾患:
Coronary Disease

活動性強直性脊椎炎患者におけるビメキズマブの有効性と安全性を評価する研究

完了NCT03928743第3相

The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).

対象疾患:
Ankylosing Spondylitis

進行固形腫瘍患者を対象としたGSK3745417のヒト初回投与試験(FTIH試験)

実施中(募集終了)NCT03843359第1相

This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.

対象疾患:
Neoplasms

新たに診断された未治療の急性リンパ性白血病患者を対象としたSHP674(ペガスパルガーゼ)の臨床試験

完了NCT04067518第2相

The objectives of the study are to assess the safety and tolerability of a single dose of SHP674 in Japanese participants (dose confirmation) in the tolerability assessment period of Part 1 and to assess the safety, pharmacokinetics and efficacy of SHP674 dose in Part 2 (found to be tolerated in Part 1) in the treatment of newly diagnosed untreated acute lymphoblastic leukemia (ALL) in Japanese participants.

対象疾患:
Acute Lymphoblastic Leukemia

ペフィシチニブの関節リウマチ患者における安全性及び有効性を評価するための製造販売後調査

募集中NCT03971253

この研究の目的は、ペフィシチニブで治療したすべての関節リウマチ(RA)患者を対象に、日常の臨床診療と実際の臨床現場における安全性と有効性を調査することです。

対象疾患:
関節リウマチ(RA)

尿路上皮癌および線維芽細胞増殖因子受容体遺伝子異常を有する参加者を特定するための研究

完了NCT03955913

The purpose of this non-interventional study is to identify participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations through molecular testing of their archival tumor tissue.

対象疾患:
Receptors, Fibroblast Growth FactorUrothelial Cancer

再発性または難治性の低悪性度B細胞性非ホジキンリンパ腫患者を対象としたME-401の試験

完了NCT03985189第1相

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma and to continue administraion of ME-401 to patients with relapsed or refractory B-cell NHL with collecting safety information

対象疾患:
Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma