治験一覧
8,963 件中 3241〜3260 件を表示
高リン血症患者におけるKHK7791の用量探索試験
To evaluate the effect and safety of KHK7791 to treat Hyperphosphatemia in ptatients on HD.
再発性／難治性多発性骨髄腫（RRMM）患者を対象とした多施設共同、非盲検、第1b相試験
Primary Objectives: * To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) * To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device * To evaluate the pharmacokinetics (PK) of SC and IV isatuximab Secondary Objectives: * To estimate absolute bioavailability of SC and IV isatuximab * To measure receptor occupancy (RO) after isatuximab SC versus IV administration * To assess efficacy of isatuximab after SC and IV administration * To assess patient expectations prior to and patient experience and satisfaction after SC administration * To evaluate potential immunogenicity of SC or IV isatuximab
うっ血性心不全患者におけるOPC-61815注射剤とトルバプタン15mg錠の有効性および安全性比較試験
To confirm the non-inferiority of OPC-61815 16-mg injection to tolvaptan 15-mg tablet using as the primary endpoint the change in body weight following 5-day intravenous administration of OPC-61815 16-mg injection or 5-day oral administration of tolvaptan 15-mg tablet to CHF patients with volume overload despite having received diuretics other than vasopressin antagonists
トレーニングやスポーツによる筋疲労のある人に対する経皮的電気神経刺激の効果
The objective is to assess if TENS will improve the muscle recovery rate from post-exercise fatigue.
健康な成人におけるバルドキソロンメチルの臨床薬理学的研究
Food effect part: To investigate the effect of food on the pharmacokinetics of RTA 402 and evaluate the safety of RTA 402 in Japanese healthy male adults, using the capsule formulations. Caucasian subject part: To investigate the pharmacokinetics of a single dose of RTA 402 administered in the fasted state and compare the pharmacokinetics with those observed in Japanese healthy male adults in the food effect part
リゲリズマブによる以前の臨床試験を完了した慢性特発性蕁麻疹患者におけるリゲリズマブの有効性および安全性に関する研究
The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).
子宮内膜癌に対するペムブロリズマブ（MK-3475）＋レンバチニブ（E7080/MK-7902）と化学療法（ENGOT-en9/MK-7902-001）の比較
本試験の目的は、ステージIII、IV、または再発性子宮内膜癌の女性患者を対象に、ペムブロリズマブとレンバチニブの併用療法の有効性を化学療法と比較することです。盲検独立中央判定（BICR）による固形癌治療効果判定基準バージョン1.1（RECIST 1.1）に基づく無増悪生存期間（PFS）において、ペムブロリズマブとレンバチニブの併用療法は化学療法よりも優れていると仮定されています。また、全生存期間（OS）においても、ペムブロリズマブとレンバチニブの併用療法は化学療法よりも優れていると仮定されています。 修正7の時点で、試験終了時に適格な患者は、継続試験（利用可能な場合）に移行することができ、親試験と同様に、ペムブロリズマブ単剤療法、レンバチニブ単剤療法、またはペムブロリズマブとレンバチニブの併用療法を継続して受けることができます。
局所進行性または転移性TNBC患者に対する第一選択治療としてのカピバセルチブ+パクリタキセル
Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)
成人日本人腎移植患者におけるヒトサイトメガロウイルス（CMV）感染および疾患の予防におけるMK-8228（レテルモビル）（MK-8228-042）
This study aims to evaluate the safety, efficacy and pharmacokinetics (PK) of Letermovir (LET) administered as prevention of cytomegalovirus (CMV) infection and disease in adult Japanese kidney transplant recipients.
MitraClip EXPAND G4 試験
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
中枢神経痛に対するミロガバリンの研究
Investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo
TS-142の健常者における安全性、薬物動態および薬力学的試験
The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly and elderly participants
KW-3357の早期発症重症妊娠高血圧症患者を対象とした研究
The purpose of this study is to evaluate the efficacy of intravenous KW-3357 in patients with early-onset severe preeclampsia by comparing the prolongation days of pregnancy with that of placebo.
成長ホルモン欠乏症の小児に対するMOD-4023の安全性および有効性に関する研究
Treatment of children with growth failure due to growth hormone deficiency (GHD). Primary • To evaluate the efficacy and safety of weekly MOD-4023 administration compared to daily Genotropin® administration in Japanese pre-pubertal children with GHD. Secondary • To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of three different doses of MOD-4023 in Japanese pre-pubertal children with GHD.
切除不能ステージIまたはIIの非小細胞肺癌（NSCLC）成人患者におけるペムブロリズマブ（MK-3475）併用または非併用による定位放射線治療（SBRT）の有効性および安全性試験（MK-3475-867/KEYNOTE-867）
The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected Stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC). The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution).
全身性膿疱性乾癬および紅皮症性乾癬の日本における被験者を対象としたイキセキズマブ（LY2439821）の臨床試験
The reason for this study is to see if the study drug ixekizumab is safe and effective in participants with generalized pustular psoriasis and erythrodermic psoriasis.
全身性エリテマトーデス（SLE）におけるPF-06700841の有効性および安全性を評価するための用量設定試験
Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
尿路上皮癌におけるシスプラチン不適応患者（腫瘍がプログラム細胞死リガンド1を発現）およびプラチナ製剤含有化学療法が不適応の患者を対象とした、ペムブロリズマブ（MK-3475）とレンバチニブ（MK-7902/E7080）の併用による第一選択薬の試験（MK-7902-011/E7080-G000-317/LEAP-011）
The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC). The primary hypotheses for this study are that: 1. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and 2. Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS). Based on recommendation of the external Data Monitoring Committee (eDMC), Amendment 3 (effective: September \[Sep\]-24-2021) was implemented to unblind the study and discontinue lenvatinib and placebo treatment. The eDMC was then disbanded. With Amendment 4 (effective: December-5-2022) second course pembrolizumab will no longer be offered. Any participant receiving second course pembrolizumab treatment prior to initiation of Amendment 4 will be able to complete treatment as planned. Study participation will end after the final administration of pembrolizumab. Participants who either complete 35 administrations of pembrolizumab or discontinue pembrolizumab will discontinue from the study following the safety follow-up visit. AEs and spontaneously reported pregnancies will be reported and followed per protocol. The overall study ends when the last participant completes the last study-related contact or visit, withdraws from the study, or is lost to follow-up.
進行胃腸癌患者におけるBI 905711の安全かつ効果的な投与量を見つけるための研究
Phase 1a - Explore safety and establish the maximum tolerated dose (MTD)/recommended dose levels for phase Ib expansion phase of BI 905711 based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period. The MTD evaluation period is defined as the first two treatment cycles (from first dose administration until the day preceding the third dose administration or end of REP in case of discontinuation before start of Cycle 3). Phase 1a - Explore pharmacokinetics/pharmacodynamics, and efficacy to guide the determination of a potentially effective dose range for phase Ib in the absence of MTD. Phase 1b - Evaluate efficacy and safety of BI 905711 at a potentially effective dose range and determine the Recommended Phase 2 Dose (RP2D)
グラクソ・スミスクライン（GSK）の呼吸器合胞体ウイルス（RSV）ワクチン候補の安全性と免疫反応を日本人高齢者を対象に検証する研究
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 doses of GSK Biologicals' RSV candidate vaccine adjuvanted with AS01B for the prevention of lower respiratory tract diseases caused by RSV in ethnic Japanese adults 60-80 years of age.