治験一覧
8,963 件中 4321〜4340 件を表示
固形腫瘍患者を対象としたE7389リポソーム製剤の研究
The maximum tolerated dose (MTD) of E7389 liposomal formulation (E7389-LF) will be determined in the dose escalation part. Safety, pharmacokinetics (PK) and efficacy will be assessed using treatment regimen evaluated in dose escalation part in participants with breast cancer (up to 3 prior regimens of chemotherapy) in the expansion part 1 and in participants with adenoid cystic carcinoma (ACC), gastric cancer (GC), esophageal cancer (EGC), small cell lung cancer (SCLC) and breast cancer (with no prior regimens of chemotherapy) in the expansion part 2, 3, 4, 5 and 6 respectively.
健康なボランティアおよび発作性夜間ヘモグロビン尿症患者におけるクロバリマブの安全性、有効性、薬物動態および薬力学を評価する研究
This is a Phase I/II, first-in-human study consisting of four sequential parts and an open-label extension (OLE). The safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single doses of crovalimab will be evaluated in healthy volunteers (HV) during part 1. The safety, tolerability, PK and PD of multiple doses of crovalimab will be evaluated in participants with paroxysmal nocturnal hemoglobinuria (PNH) in parts 2, 3, 4, and OLE of the study. Efficacy of crovalimab will be evaluated in Parts 2, 3, and 4.
深部静脈血栓症および肺塞栓症患者における再発予防のためのリバーロキサバンの有効性および安全性に関する日本登録データ
To clarify the effectiveness and safety of the direct factor Xa inhibitor rivaroxaban in domestic clinical use for patients with deep vein thrombosis and pulmonary embolism
進行性または転移性胆道癌に対するバルリチニブとカペシタビンの併用療法
This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer. Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer by simultaneous inhibition of these receptors. The purpose of this study is to determine the safety and efficacy of Varlitinib in combination with capecitabine for the treatment of Biliary Tract Cancer. Treatment groups are Varlitinib+capecitabine and Placebo + capecitabine
慢性片頭痛の予防治療におけるTEV-48125の皮下投与の有効性および安全性
To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 \[monthly TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3 months\] compared with placebo for preventive treatment in Chronic Migraine patients
日本人肥満患者におけるLIK066投与後の体重変化を評価するための用量探索試験
The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease.
再発性または難治性のB細胞非ホジキンリンパ腫患者を対象としたタゼメトスタットの研究
This is a multicenter, single-arm, open-label, Phase 1 study to assess the tolerability, safety, pharmacokinetics, and preliminary anti-tumor activity of tazemetostat in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).
原発開放隅角緑内障または眼圧亢進症患者におけるDE-126点眼液の安全性および有効性に関する第IIb相試験 - Angel試験
Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension. The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.
アディノベート薬剤使用結果調査
The purpose of this survey is to understand the following items in the actual clinical use of ADYNOVATE in patients: 1. Unexpected adverse drug reactions 2. Occurrence of adverse drug reactions in the actual clinical use 3. Factors that may affect safety and efficacy 4. Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII deficiency (hereinafter hemophilia A) 5. Safety and efficacy for hemophilia A patients who received routine prophylactic therapy and on-demand therapy
日本におけるBRCA遺伝子変異を有するプラチナ製剤感受性再発高悪性度上皮性卵巣がん患者を対象としたオラパリブ拡大アクセスプログラム
This is a single-arm, open label, expanded access program to provide access to olaparib tablets for relapsed high-grade epithelial ovarian cancer patients (including patients with primary peritoneal and / or fallopian tube cancer) with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious \[known or predicted to be detrimental/lead to loss of function\]) who have responded following platinum based chemotherapy. Patients may continue to receive study treatment until disease progression as assessed by the investigator according to local standard clinical practice or any other discontinuation criteria are met.
進行肝細胞癌患者における第一選択治療としてのデュルバルマブとトレメリムマブの研究
This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy
腎臓の一部切除手術を受けた局所性腎臓がん患者を対象に、ニボルマブ単剤療法、ニボルマブとイピリムマブの併用療法、およびプラセボを比較した研究
The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.
プレベナー13の薬物使用に関する調査 - 65歳以上の成人 -
This study aims to understand the following items in post-marketing actual clinical settings to evaluate the safety of 13vPnC administered as a single dose in the elderly (adults aged 65 years or older). 1. To confirm the use in actual clinical settings 2. To confirm the occurrence of adverse events
新たにステージIIIまたはステージIVの卵巣がん、卵管がん、または原発性腹膜がんと診断された患者を対象とした、アテゾリズマブとプラセボをパクリタキセル、カルボプラチン、およびベバシズマブと併用した場合の比較試験
This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.
Arnuity® Ellipta® 薬物使用調査
The aim of this post-marketing investigation is to collect and assess the information about safety and effectiveness of ARNUITY® ELLIPTA® (hereinafter referred to as "Arnuity") in daily clinical practice. The investigation will include subjects with a diagnosis of asthma bronchial who are naïve to ARNUITY. The investigator will monitor the information about safety and effectiveness of ARNUITY for one year from the start date of ARNUITY administration and Pneumonia will be considered as the priority investigation matter. 300 subjects, from approximately 150 medical institutions, will be included in this analysis. ARNUITY ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.
子宮内膜症に伴う骨盤痛および／または月経困難症に対するヤズフレックスの薬物使用調査（DUI）
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.
従来の治療法および／または生物学的製剤による治療に十分な効果が得られなかった、または不耐性を示した中等度から重度の活動性クローン病患者におけるウパダシチニブの有効性および安全性に関する研究
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).
食道癌患者におけるニボルマブとイピリムマブ、またはニボルマブとフルオロウラシルおよびシスプラチンの併用療法とフルオロウラシルおよびシスプラチン単独療法の有効性を評価する研究
The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin
生後1ヶ月から4歳未満の小児てんかん患者における部分発作に対するレベチラセタムの単剤療法または補助療法としての効果に関する研究
This is a study to confirm the efficacy of levetiracetam as adjunctive treatment or as monotherapy in pediatric epilepsy subjects aged 1 month to less than 4 years of age with partial seizures.
ドライビングシミュレータを用いた健常者運転能力評価法の開発 #1
The purpose of this study is to set an optimal measurement time for assessing driving ability in a driving simulator in healthy volunteers.