治験一覧
8,963 件中 1581〜1600 件を表示
オンデキサ静注用200mg使用成績調査（全例調査）
This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions.
ホルモン受容体陽性／ヒト上皮成長因子受容体2陰性（HR+/HER2-）進行乳がん患者における内分泌療法の実際の治療パターン：日本の医療費請求データ分析
This is a retrospective observational study focusing on patients diagnosed with advanced breast cancer(ABC) in Japan using de-identified claim data from Medical Data Vision (MDV) database. The primary objective of this study is to describe patient demographics, treatment patterns and treatment duration of palbociclib, and subsequent treatment patterns and treatment duration after palbociclib-based therapy among ABC patients in Japan The secondary objective of the study is to describe patient demographics, treatment patterns of ABC patients and treatment duration of endocrine therapy, and subsequent treatment patterns and treatment duration after endocrine therapy among ABC patients in Japan.
プログラム細胞死リガンド1（PD-L1）腫瘍割合スコア（TPS）≥50%の転移性非小細胞肺癌（NSCLC）患者を対象とした、ペムブロリズマブ（MK-3475）単独療法とサシツズマブ・ゴビテカンのペムブロリズマブとの併用療法を比較する試験（MK-3475-D46）
The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).
上皮成長因子受容体（EGFR）変異陽性進行または転移性非小細胞肺癌患者におけるラゼルチニブとアミバンタマブ皮下注の併用療法とアミバンタマブ静脈内注の併用療法の比較試験
本試験の目的は、アミバンタマブの静脈内投与を簡素化し、投与回数を短縮することを目指し、アミバンタマブの新たな製剤であるアミバンタマブ皮下投与剤および組換えヒトヒアルロニダーゼ（SC-CF）配合剤（皮下投与用）を評価することです。この製剤は、アミバンタマブの投与をより簡便かつ迅速に行うことで、患者と医師の双方にとってアミバンタマブの投与体験を向上させる可能性を秘めています。
inBody検査による肝胆膵癌患者の術後転帰
postoperative outcomes were evaluated by using inBody test
遺伝性ミトコンドリア疾患患者におけるバチキノン（PTC743）による既治療例の安全性試験
The primary objective of this study is to assess the safety of vatiquinone in participants with inherited mitochondrial disease who had prior exposure to vatiquinone in a PTC/BioElectron sponsored (previously Edison) clinical study or treatment plan. The study will continue until vatiquinone becomes commercially available or the program is terminated.
未治療の局所進行手術不能または転移性トリプルネガティブ乳がん患者におけるサシツズマブ・ゴビテカン-hziyと医師選択治療の比較試験
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.
局所進行性肝細胞癌患者におけるデュルバルマブおよびトレメリムマブ±レンバチニブとTACEの併用療法の評価
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma
遺伝性血管性浮腫（HAE）の青年および成人患者における血管性浮腫発作のオンデマンド治療におけるKVD900（セベトラルスタット）の有効性と安全性を評価する第III相クロスオーバー試験
This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult Patients
進行固形腫瘍患者を対象としたNIB101の研究
NIB101-01 study is an open-label, non-randomized Phase 1 study in participants with GM2 positive advanced solid tumor, who failed to available standard of cares to evaluate the safety and tolerability of NIB101.
糖尿病性末梢神経障害の疼痛患者を対象としたMT-8554の探索的試験
The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of MT-8554, compared to placebo, in subjects with painful diabetic peripheral neuropathy.
好酸球性胃炎および/または胃腸炎患者におけるベンラリズマブの有効性と安全性（HUDSON GI試験）
This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease. After completing Part A, participants can continue to Part C - open-label benralizumab treatment period. Following the decision to close enrollment, patients in both Part A and Part C will be given the option to proceed to 6-months of open-label benralizumab treatment in Part D.
非ホジキンリンパ腫（NHL）および慢性リンパ性白血病（CLL）患者を対象とした、T細胞リダイレクトCD79b x CD20 x CD3三特異性抗体JNJ-80948543の研究
The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D\[s\]), optimal dosing schedule(s) and route(s) of administration of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).
HER2陽性進行性または転移性胃癌および食道癌患者におけるザニダタマブと化学療法の併用とティスレリズマブの併用に関する研究
This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).
統合失調症患者におけるブレクスピプラゾール週1回投与製剤の長期投与試験
Confirm the tolerability and safety of long-term administration of the brexpiprazole QW formulation in patients with schizophrenia
早期アルツハイマー病患者におけるアデュカヌマブの臨床的有用性を検証する研究
The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.
健康成人を対象とした経口エダラボンの臨床薬理試験（食事影響試験）
To evaluate the effect of food on the pharmacokinetics of oral edaravone in healthy adult subjects. In this study, we determined 5 different dietary conditions including 4 different meal contents and fasting condition.
心臓浮腫（うっ血性心不全[CHF]）におけるOPC-131461の用量範囲試験
To investigate the dose response in respect of weight decrease following repeated oral administration of OPC-131461 at 1, 2, 5, and 10 mg or placebo in patients with CHF with volume overload despite having received diuretics other than vasopressin antagonists
インヒビター保有の有無にかかわらず血友病患者を対象としたマルスタシマブの非盲検継続試験
Study B7841007 is an open-label extension study to assess the long-term safety, tolerability, and efficacy of prophylaxis treatment with marstacimab in participants who did not require "Early Termination" from the Phase 3 Study B7841005 and from the Phase 3 Study B7841008. Study B7841005: approximately 145 adolescent and adult participants 12 to \<75 years of age with severe hemophilia A or moderately severe to severe hemophilia B (defined as FVIII activity \<1% or FIX activity ≤2%, respectively) with or without inhibitors are expected to be enrolled in Study B7841005 during which they will receive prophylaxis (defined as treatment by SC injection of marstacimab). Study B7841008: this is an ongoing Phase 3, open-label study in pediatric participants \<18 years of age with severe hemophilia A (FVIII Coagulation Factor Activity \<1%) or moderately severe to severe hemophilia B (FIX Coagulation Factor Activity ≤2%). A sequential approach will be used in enrolling at least 100 pediatric participants, at least 20 of which will be aged ≥12 to \<18 years and at least 80 participants will be aged ≥1 to \<12 years. At the start of study B7841008, the dosing and data available in adolescent and adult participants in Study B7841005 supported the initiation of B7841008 study in participants aged ≥12 to \<18 years. Subsequently, additional safety and efficacy data from adolescent participants in Study B7841005 became available for benefit/risk assessment in support of dosing participants aged ≥6 to \<12 years. Based on the positive benefit/risk assessment conducted by both internal Pfizer review and eDMC review, dosing of the ≥6 to \<12 years age group was initiated in June 2023 in B7841008 Study. Data from participants ≥6 years from B7841008 Study and Study B7841005 will support the dosing of participants aged ≥1 to \<6 years. All participants will be provided the prefilled pen (PFP) for administration of marstacimab in the study. Use of the prefilled syringe (PFS) will be permitted at the investigator's discretion for those participants who have difficulty with administration of the PFP. Additionally, participants will be provided the PFS for use in this study in countries where the PFS is anticipated to be the only presentation available commercially. An optional, open-label, single arm, substudy using the PFP was completed in the first 23 participants rolled over from Study B7841005 who agreed to participate in the substudy.
BI 690517の異なる用量を単独またはエンパグリフロジンとの併用で投与した場合、慢性腎臓病患者の腎機能が改善するかどうかを検証する研究
This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study. The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin. In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine. In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.