治験一覧
8,963 件中 4341〜4360 件を表示
少なくとも1種類の非生物学的疾患修飾性抗リウマチ薬（DMARD）で十分な効果が得られなかった乾癬性関節炎患者を対象に、ウパダシチニブ（ABT-494）とプラセボおよびアダリムマブを比較する試験
This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.
本研究は、健康な中国人および日本人男性を対象にBI 685509を試験するものであり、BI 685509の様々な投与量が体内でどのように吸収され、どの程度忍容されるかを検証するものである。
The primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 685509 in healthy Chinese and Japanese subjects.
本研究は、健康な日本人男性および白人男性を対象にBI 1467335の有効性を検証するものです。本研究では、BI 1467335の様々な投与量が体内でどのように吸収され、どの程度忍容されるかを検証します。
The primary objective of the current study is to investigate the safety and tolerability of BI 1467335 in healthy Japanese male subjects following oral administration of multiple rising doses The Caucasian group will receive higher dose only. A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 1467335 in healthy Japanese and Caucasian male subjects.
日本におけるZS第2/3相用量反応試験
To assess efficacy of 5 g three times daily (TID) and 10 g TID ZS versus placebo in Japanese patients with hyperkalemia (serum potassium \[S-K\] ≥ 5.1 mmol/L and ≤ 6.5 mmol/L).
進行性腫瘍患者におけるBMS-986205とニボルマブの併用投与に関する研究
The purpose of this study is to assess the safety and tolerability for the combination therapy of BMS-986205 and Nivolumab in patients with advanced tumors
特定の固形腫瘍患者を対象としたレンバチニブとペムブロリズマブ併用療法の第1b相臨床試験
This is an open-label Phase 1b study designed to confirm the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with selected solid tumors (non-small cell lung cancer, predominantly clear cell renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, or melanoma \[excluding uveal melanoma\]).
再発性または難治性急性リンパ性白血病に対するTBI-1501の研究
Evaluate the safety (P-I), pharmacokinetics and anti-tumor effect of immunotherapy of autologous T cells genetically modified to express anti-CD19 chimeric antigen receptor (CAR) (TBI-1501) for relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia.
術後疼痛治療におけるSyB P-1501（フェンタニル塩酸塩）の研究
This is a Phase 3 clinical trial to compare the safety and efficacy of SyB P-1501 with the SyB P-1501 placebo for the management of the first 24 hours of post-operative pain.
デュシェンヌ型筋ジストロフィーの歩行可能な男児におけるRO7239361の有効性、安全性、および忍容性を評価する臨床試験
This is a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of two different weekly doses of RO7239361 in ambulatory boys with Duchenne Muscular Dystrophy (DMD).
ヒト連続培養培地システムへの抗酸化物質の添加
Upon collection, human oocytes are fertilized and culture up to the blastocyst stage, followed by transfer and / or cryopreservation. Culture media systems have been developed that support each step of this process. Although these culture media systems try to mimic the natural environment, several components of the in-vivo situation are not present in today´s media. One such component is anti-oxidants that may protect embryos against damage by reactive oxygen species. This investigation aims to compare blastocyst development using 2 different types of culture media systems, one of which contains antioxidants. Patients having at least eight oocytes and meeting other inclusion criteria can be included in this investigation. It is a prospective randomized multicenter study randomly dividing oocytes into two groups and assessing parameters of embryo development from fertilization up to blastocyst formation until day six. Embryos with acceptable developmental characteristics can be transferred into the uterus or cryopreserved for later use. The investigation is designed as a superiority study comparing utilization rate of blastocysts per normally fertilized oocyte using both media systems. In patients receiving embryo transfer in the fresh treatment cycle, detection of clinical pregnancy by ultrasound after 12 weeks gestation is the final endpoint of the investigation.
慢性腎臓病（CKD）に伴う貧血を有する日本人血液透析（HD）患者におけるダプロデュスタットとダルベポエチンアルファの有効性および安全性を評価する研究
Daprodustat is a drug that is currently being developed as a treatment for renal anemia . This study is to evaluate the efficacy and safety of daprodustat following a switch from erythropoiesis-stimulating agent (ESA) in Japanese HD subjects with renal anemia who are currently treated with ESA. The primary objective is to demonstrate non-inferiority of daprodustat to darbepoetin alfa. This study is a 52-week, Phase III, double-blind, active-controlled, parallel-group, multi-center study. The total duration of the study will be approximately 58 weeks including screening and follow-up.
TAVIにおける血栓形成の評価
Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI compared to those in surgical aortic valve replacement, those in TAVI still remains high. In addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach. The antithrombotic regimen in patients undergoing TAVI is needed to be established. To establish the antithrombotic regimen in patients undergoing TAVI, 1. the investigators assess the changes in platelet thrombus formation and white thrombus formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis System (T-TAS). 2. the investigators analyze plasma microRNAs, and shear stress by using computational fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.
ホモ接合型家族性高コレステロール血症（HoFH）患者を対象とした研究
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment. The secondary objectives of the study are: * To evaluate the effect of alirocumab Q2W on other lipid parameters (ie, apolipoprotein \[Apo\] A-1 and B, non-high-density lipoprotein cholesterol \[non-HDL-C\], total-cholesterol \[TC\], proportion of participants with 15%, 30%, and 50% LDL-C reductions, Lp(a), HDL-C, triglycerides \[TG\]) in participants with HoFH * To evaluate the safety and tolerability of alirocumab SC Q2W in participants with HoFH * To assess the pharmacokinetics of alirocumab SC Q2W in participants with HoFH * To assess the potential development of anti-drug (alirocumab) antibodies
胃がんまたは胃食道接合部がん患者を対象としたラムシルマブとニボルマブの併用療法に関する第1/2相試験
The main purpose of this study is to evaluate the safety and efficacy of the combination therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable gastric or GEJ cancer.
アルグルコシダーゼアルファによる治療を受けた乳児期発症ポンペ病の小児患者におけるアバルグルコシダーゼアルファの隔週投与の安全性と有効性を評価する研究
This is a multi-stage, phase 2, open-label, multicenter, multinational, ascending dose cohort, repeated intravenous (IV) infusion study of avalglucosidase alfa in pediatric patients with Infantile-Onset Pompe Disease (IOPD) who have been previously treated with alglucosidase alfa for a minimum of 6 months immediately prior to study entry and have demonstrated clinical decline or unsatisfactory clinical response.
中等度から重度の慢性乾癬を有する日本人被験者におけるセルトリズマブ ペゴルの有効性および安全性を検証する研究
The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese subjects.
セクキヌマブが強直性脊椎炎の放射線学的進行に及ぼす影響（GP2017（アダリムマブバイオシミラー）との比較）
The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).
未治療の局所進行性または転移性トリプルネガティブ乳がん（TNBC）患者を対象とした、アテゾリズマブとパクリタキセルの併用療法とプラセボとパクリタキセルの併用療法を比較した研究
This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 \[PD-L1\] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.
慢性うつ病に対するスキーマ療法
To compare the efficacy of schema therapy versus active monitoring for women with chronic depression receiving psychiatric care.
転移性または切除不能な非小細胞肺癌におけるU3-1402
This study was designed to evaluate safety and antitumor activity of HER3-DXd in two parts: Dose Escalation and Dose Expansion. In Dose Escalation, HER3-DXd was evaluated in participants with metastatic or unresectable NSCLC with epidermal growth factor receptor (EGFR) activating mutation after disease progression during/after EGFR tyrosine kinase inhibitor (TKI) therapy. In Dose Expansion, HER3-DXd will be evaluated in participants with metastatic or unresectable NSCLC with EGFR activating mutation or squamous or non-squamous NSCLC (ie, without EGFR-activating mutations) with disease progression during/after systemic treatment for locally advanced or metastatic disease. In addition, HER3-DXd will be evaluated in participants with locally advanced or metastatic NSCLC whose tumors harbor a KRAS-G12C mutation after progression on the most recent line of therapy (Cohort 5).