🏥 治験ポータル

治験一覧

8,963 件中 46214640 件を表示

小児がん患者におけるオララツマブ単剤療法および標準化学療法との併用療法に関する研究

完了NCT02677116第1相

The main purpose of this study is to evaluate the safety of different doses of olaratumab and to determine which dose should be used for future pediatric studies. The present study is open to children with advanced cancer or cancer that has spread to another part of the body. The study has three parts. In the first two parts, a specific dose of olaratumab will be given in 21 day cycles, followed by one of three standard chemotherapy regimens. In the third part, a specific dose of olaratumab will be given with one of three standard chemotherapy regimens in 21 day cycles. Participants will only enroll in one part.

対象疾患:
Neoplasm Metastasis

抗血栓薬を継続服用している患者におけるEGDおよび大腸内視鏡検査後の出血率

募集中NCT02594813

The bleeding rate of both EGD (including biopsy) and colonoscopy (including biopsy, cold or hot snare polypectomy, or EMR) in patients who continue to take various antithrombotic drugs is studied prospectively. The immediate or delayed bleeding that requires hemostatic clipping or other endoscopic treatments is defined as the bleeding. Immediate bleeding requiring hemostatic clipping is defined as spurting or oozing which continued for more than 30 seconds. Delayed bleeding is defined as bleeding that requires the endoscopic treatment within 2 weeks after endoscopy. Prophylactic clipping is not performed after taking biopsy and doing polypectomy. Additionally, investigators evaluate the rate of injured submucosal arteries of the excised specimen when the bleeding occurs.

対象疾患:
Bleeding After GI Endoscopy

腹膜透析を受けている貧血を伴う慢性腎臓病患者におけるASP1517の間欠的経口投与に関する研究

完了NCT02780726第3相

The objective of this study is to evaluate the safety and efficacy of ASP1517 in peritoneal dialysis chronic kidney disease patients with anemia.

対象疾患:
Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia

ヘリコバクター・ピロリ菌除菌におけるラベプラゾールとエソムペラゾールの比較

完了NCT02767479第3相

Patients infected with H. pylori are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and CAM 200 mg bid. Eradication rates are compared. Patients who have ever failed in eradication by CAM-based regimen are treated with rabeprazole 10 mg bid, AMPC 750 mg bid and MNZ 250 mg bid or esomeprazole 20 mg bid, AMPC 750 mg bid and MNZ 250 mg bid.

対象疾患:
H. Pylori Infection

胸部大動脈瘤および穿通性動脈硬化性潰瘍患者におけるRelayPro胸部ステントグラフト

実施中(募集終了)NCT02818972該当なし

Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.

対象疾患:
Aortic Aneurysm, ThoracicPenetrating Ulcer

1型糖尿病患者におけるASP1941とインスリンの併用に関する研究

完了NCT02897219第3相

The objective of this study is to confirm efficacy of ASP1941 based on the changes in HbA1c and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once daily in combination with insulin for 24 weeks. This study will also assess the safety/efficacy of long-term treatment (52 weeks).

対象疾患:
Type 1 Diabetes Mellitus

健康な日本人被験者におけるトレプロスチニルおよびLY900014の新製剤に関する研究

完了NCT02770521第1相

The aims of this study are to evaluate: * The safety and tolerability of a single dose of treprostinil given subcutaneously (as an injection just under the skin) * The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants. The study has two parts. Participants may only enroll in one part.

対象疾患:
Healthy

アジア全域における米国での突然心臓死予防のためのカテーテルアブレーション試験

完了NCT02848781該当なし

The current standard of care for ventricular tachycardia (VT) includes the use of medicine called anti-arrhythmic drugs (AADs) and Implantable Cardioverter Defibrillator (ICD) therapy. These treatments are used to terminate the irregular heartbeats and bring the heart back to a normal rhythm. Catheter ablation is a procedure used to eliminate (damage) the heart cells causing the arrhythmia. Patients eligible for this may benefit from an ablation procedure in addition to an ICD to treat their VT condition or risk of developing VT. This study aims to show that treating VT with catheter ablation, if performed preemptively at the time of ICD implantation, will reduce subsequent recurrent VT, ICD shocks, and lead to improved survival.

対象疾患:
Ventricular Tachycardia (VT)

LEO 80185ゲルの皮膚薬物動態試験

完了NCT02605057第1相

Given that LEO 80185 gel takes effect in the upper layer of the skin, it is important to compare and examine the amount of the drug in the upper layer of the skin with that of Dovobet® Ointment. Therefore, a dermatopharmacokinetic study will be conducted in healty adult male volunteers to evaluate pharmacokinetics of LEO 80185 gel and Dovobet® Ointment in the stratum corneum. In this trial, a single application of LEO 80185 gel and Dovobet® ointment will be applied to multiple test sites on the back of healthy Japanese male adults and the trial is designed to compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The amount of calcipotriol and betamethasone dipropionate in the stratum corneum will be assessed by use of tape stripping.

対象疾患:
Psoriasis Vulgaris

ピロリ菌23S rRNAの変異に基づいた個別化ピロリ菌除菌療法

不明NCT02761005第2相

Patients infected with H. pylori are treated with the individualized regimen which is based on the mutation of 23S rRNA of H. pylori.

対象疾患:
H. Pylori Infection

再発性膠芽腫に対するベバシズマブ単剤療法と高用量テモゾロミド投与後にベバシズマブを投与する療法との比較、第III相試験

不明NCT02761070第3相

The aim of this Phase III study is to evaluate the superiority of dose-dense temozolomide (ddTMZ) followed by bevacizumab at ddTMZ failure for glioblastoma at first recurrence or progression, comparing to bevacizumab alone.

対象疾患:
GlioblastomaProgressionRecurrence

進行性悪性腫瘍患者を対象としたMCS110とPDR001の併用療法に関する第Ib/II相試験

完了NCT02807844第1/第2相

The purpose of this study of MCS110 with PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.

対象疾患:
Endometrial CarcinomaMelanomaPancreatic CarcinomaTriple Negative Breast Cancer

BRAF V600E変異を有する転移性結腸直腸癌患者における、エンコラフェニブ+セツキシマブ(ビニメチニブ併用または非併用)とイリノテカン/セツキシマブまたは持続点滴5-フルオロウラシル(5-FU)/葉酸(FA)/イリノテカン(FOLFIRI)/セツキシマブ(安全性導入としてエンコラフェニブ+ビニメチニブ+セツキシマブを併用)との比較試験

完了NCT02928224第3相

This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.

対象疾患:
BRAF V600E-mutant Metastatic Colorectal Cancer

中等度の腎機能障害を有する高血圧患者におけるCS-3150とARBまたはACE阻害薬との併用に関する研究

完了NCT02807987第3相

To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with moderate renal impairment.

対象疾患:
Hypertension With Moderate Renal Impairment

エリキュース(アピキサバン)の静脈血栓塞栓症(VTE)の治療および再発性VTEの予防における市販後規制監視

完了NCT02836457

The primary objectives of this study is to estimate the real-world safety profile of Eliquis in Japanese Venous Thromboembolism patients and to estimate the risk factors likely to affect the incidence of bleeding. Lastly, the secondary objective of this study is to estimate the real-world effectiveness profile of Eliquis in Japanese Venous Thromboembolism patients.

対象疾患:
Venous Thromboembolism

ゼニス® TXDの日本における市販後調査

完了NCT02663739

The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval

対象疾患:
Aortic Dissection

Ryzodeg®の長期使用に関する市販後調査(特殊使用結果調査)

完了NCT02821052

This trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.

対象疾患:
Diabetes

健康な日本人成人を対象としたPF-06650833の徐放性製剤に関する研究

完了NCT02936154第1相

The purpose of this study is to evaluate the tolerability, safety and pharmacokinetics of PF-06650833 orally administered as modified release tablets in healthy Japanese subjects.

対象疾患:
Healthy

骨転移による癌性疼痛があり、背景治療としてオピオイド療法を受けている患者におけるタネズマブの有効性および安全性に関する第3相試験

完了NCT02609828第3相

The purpose of this study is to determine whether tanezumab is effective in the treatment of cancer pain due to bone metastasis in patients already taking background opioid therapy.

対象疾患:
Bone MetastasisCancer Pain

術前化学放射線療法後のニボルマブ投与に関する研究

不明NCT02948348第1/第2相

This is a phase Ib/II, open-label, single-arm, multicenter study to investigate the safety, efficacy, and proof of concept (POC) of monotherapy with nivolumab, an anti-PD-1 antibody drug, as a sequential therapy following chemoradiotherapy (CRT) with capecitabine and subsequent surgical therapy in patients with locally advanced resectable rectal cancer.

対象疾患:
Cancer of Rectum