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Prizbind®の全事例監視

完了NCT02946931

To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.

対象疾患:
Hemorrhage

中性脂質蓄積症(NLSD)/トリグリセリド沈着性心筋血管症(TGCV)および関連疾患の国際レジストリ研究

募集中NCT02918032

This study aims to understand the state of onset of NLSD(neutral lipid storage disease) / TGCV(triglyceride deposit cardiovasculopathy) worldwide, background information of affected patients, and natural history of the disease, as well as exploring the prognostic factors and assessing the efficacy of disease-specific treatment.

対象疾患:
中性脂質蓄積症

イキサゾミブロールオーバー試験

完了NCT02924272第2相

The purpose of this study is to provide continued access to ixazomib and/or other study drugs from an ixazomib parent study.

対象疾患:
AmyloidosisLymphomaMultiple Myeloma

日本における2型糖尿病患者に対する経口血糖降下薬(OAD)併用時のインスリングラルギン/リキシセナチド固定比配合剤(リキシラン)とリキシセナチド単剤療法の有効性および安全性

完了NCT02749890第3相

Primary Objective: To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus. Secondary Objective: To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs) over a 52 week treatment period in patients with type 2 diabetes mellitus.

対象疾患:
Type 2 Diabetes Mellitus

高用量療法および自家幹細胞移植の適応とならない、未治療の多発性骨髄腫を有する日本人患者を対象とした、JNJ-54767414(ダラツムマブ)とレナリドミドおよびデキサメタゾンの併用療法に関する研究

完了NCT02918331第1相

The purpose of this study is to evaluate the safety of daratumumab when combined with lenalidomide and dexamethasone in Japanese participants with newly diagnosed multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplantation (ASCT).

対象疾患:
Multiple Myeloma

局所進行性または転移性尿路上皮癌患者におけるアベルマブの臨床試験(JAVELIN Bladder 100)

完了NCT02603432第3相

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

対象疾患:
Urothelial Cancer

骨転移を伴う去勢抵抗性前立腺癌に対するゾフィゴの薬物使用調査

完了NCT02803437

This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.

対象疾患:
Prostatic Neoplasms, Castration-Resistant

ASP8825 - ASP8825の薬物動態に対する食事の影響を調査する研究

完了NCT02632331第1相

The objective of this study is to evaluate the effect of food on the pharmacokinetics and safety after administration of ASP8825 in healthy non-elderly adult male subjects.

対象疾患:
Healthy Volunteers

過去にヌシネルセン(ISIS 396443)の治験に参加した脊髄性筋萎縮症(SMA)患者を対象とした研究

完了NCT02594124第3相

The primary objective is to evaluate long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen.

対象疾患:
Spinal Muscular Atrophy

脳実質内圧モニタリング装置を用いた侵襲的脳内圧モニタリングを受けている患者における非侵襲的脳内圧モニタリングの評価

一時中断NCT02773888該当なし

Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head. HS-1000 device, a proprietary non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians.

対象疾患:
Brain InjuriesBrain NeoplasmsHydrocephalusIntracranial HypertensionStroke

孤立性皮膚血管炎に関する無作為化多施設共同研究

募集中NCT02939573第2相

Multi-center sequential multiple assignment randomized trial comparing the effectiveness of three different standard of care treatment options for patients with isolated skin vasculitis.

対象疾患:
Cutaneous Polyarteritis NodosaHenoch-Schönlein PurpuraIgA VasculitisPrimary Cutaneous Vasculitis

FYU-981の物質収支研究

完了NCT02901366第2相

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.

対象疾患:
Healthy Male Subjects

日本人患者向けイダルシズマブCUプログラム

完了NCT02831660第3相

The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required.

対象疾患:
Hemorrhage

運動症状の変動を伴うパーキンソン病患者におけるPF-06649751の有効性、安全性および忍容性

中止NCT02687542第2相

The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.

対象疾患:
Parkinson Disease

ZOSTER-006(NCT01165177)およびZOSTER-022(NCT01165229)試験でプラセボを投与された被験者における、GSKバイオロジカルズの帯状疱疹サブユニット(HZ/su)ワクチン(GSK 1437173A)の交差ワクチン接種試験。

完了NCT02690207第3相

The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects \>= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).

対象疾患:
Herpes Zoster

レインボー拡張研究

完了NCT02640664第3相

The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)

対象疾患:
Retinopathy of Prematurity (ROP)

日本人2型糖尿病患者におけるインスリンへのエンパグリフロジンの併用療法の有効性および安全性に関する研究

完了NCT02589639第4相

This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control

対象疾患:
Diabetes Mellitus, Type 2

掌蹠膿疱症患者におけるグセルクマブの有効性と安全性

完了NCT02641730第3相

The purpose of this study is to evaluate the efficacy and safety of guselkumab for the treatment of participants with palmoplantar pustulosis.

対象疾患:
Palmoplantar Pustulosis

日本語版IP-TNトライアル

完了NCT02831569第3相

This is an open-label, single-group, multi-centre trial to confirm the safety and efficacy of loxoprofen sodium/methocarbamol ( IP-TN) when administered orally for 2 weeks to patients with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome associated with muscle strain. More than 90 patients will be screened to enroll approximately 80 patients in the trial. After giving written informed consent, patients will be enrolled in the trial. Patients who are considered eligible for the trial by the Investigator after consent and complete the trial procedures and assessments at Visit 1 will receive the trial medication and enter the open-label treatment period of 2 weeks. Patients who complete the open-label treatment period will enter the follow-up period of 1 week and complete the trial after confirmation at the last visit (or phone interview).

対象疾患:
Pain

未治療の局所進行性または転移性尿路上皮癌患者におけるアテゾリズマブ単独療法およびプラチナ製剤併用化学療法の試験

完了NCT02807636第3相

A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.

対象疾患:
Urothelial Carcinoma