治験一覧
8,963 件中 521〜540 件を表示
アルツハイマー病認知症患者におけるMK-1167の有効性と安全性を評価する試験（MK-1167-008）
Researchers want to learn if giving MK-1167 (the study medicine) along with acetylcholinesterase inhibitor (AChEI) therapy can improve symptoms of Alzheimer's disease dementia (AD dementia), such as memory and mental activity. AD dementia is the most common type of dementia. AChEI therapy is the standard treatment for AD dementia. The goals of this study are to learn: * If at least one dose level (amount) of MK-1167 works to improve a person's memory and thinking compared to a placebo * About the safety of MK-1167 and if people tolerate it
部分発作のある日本人患者におけるセノバメートの安全性
To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures
ビクタルビによる治療が奏効したHIV-1感染者におけるビクテグラビル/レナカパビルと現行療法の比較研究
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.
化学療法歴のあるKRAS/NRASおよびBRAF野生型大腸癌患者におけるアミバンタマブとFOLFIRIの併用とセツキシマブ/ベバシズマブとFOLFIRIの併用を比較する試験
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.
進行性または再発性非小細胞肺癌患者に対する二次治療として、標準治療であるドセタキセルおよびラムシルマブと併用したONO-4578およびONO-4538の非盲検非対照試験
This study is PhaseⅠstudy to evaluate the tolerability and safety of ONO-4578 and ONO-4538 in combination with standard-of-care docetaxel and ramucirumab as second-line therapy in patients with advanced or recurrent NSCLC who were refractory to a combination therapy containing an anti-PD-(L)1 antibody and a platinum-based drug
非小細胞肺がんにおけるMB12（ペムブロリズマブバイオシミラー候補）とキイトルーダ®の薬物動態、有効性、安全性、免疫原性を比較する試験（BENITO試験）
This is a randomized, multicenter, multinational, double-blind, integrated pharmacokinetics (PK) and efficacy similarity study to compare the PK, efficacy, safety, and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic non-squamous NSCLC.
慢性B型肝炎（CHB）患者を対象とした、ダプルシラン/トムリギシラン（DAP/TOM）に続いてベピロビルセンを投与する連続療法の研究
The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM followed by bepirovirsen in participants living with CHB on standard of care nucleos(t)ide analogue (NA) therapy. The study also aims to identify an optimal dose of DAP/TOM for sequenced therapy with bepirovirsen for further clinical development and to assess the contribution of DAP/TOM to the sequential regimen.
切除可能非小細胞肺癌（NSCLC）の成人患者において、病理学的完全奏効（pCR）に達していないペムブロリズマブ（MK-2870）とサシツズマブ・ティルモテカン（MK-2870）の併用または非併用の有効性と安全性を評価する試験（MK-2870-019）
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
既治療転移性膵管腺癌（PDAC）患者を対象としたダラキソンラシブ（RMC-6236）の第3相試験
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.
2種類以上の薬剤を服用している高血圧症患者（治療抵抗性高血圧症患者を含む）におけるバクスドロスタットの有効性と安全性を調査する研究
The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.
大腸がん患者に対する第一選択治療としてのONO-7913、ONO-4538および標準治療の比較研究
To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer
IDH1変異を有する局所進行性または転移性胆管癌患者における第一選択療法としてのイボシデニブ＋デュルバルマブ＋ゲムシタビン／シスプラチン
The objective of this study is to investigate the safety, tolerability and preliminary activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin as first-line therapy in participants with locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation. The study will begin with a safety lead-in phase (Phase 1b study) to determine the recommended combination dose (RDC) and then will transition to an expansion phase (Phase 2 study) to assess the clinical activity of ivosidenib in combination with durvalumab and gemcitabine/cisplatin at the RCD. During the treatment period participants will have study visits on days 1, 8, and 15 of Cycle 1, on days 1 and 8 of Cycle 2 to 8, and on day 1 of each additional cycle. Cycles 1 through 8 are 21 day cycles, and each following cycle is 28 days. Approximately 30 days and 90 days after treatment has ended, safety follow-up visits will occur and then participants will be followed for survival every 3 months. Study visits may include blood tests, ECG, vital signs, and a physical examination.
TS-172の血液透析患者における高リン血症患者を対象とした第3相臨床試験
A phase 3, randomized, placebo-controlled, double-blind study of TS-172 in hyperphosphatemia
観察研究プロトコル：LIVER-R
Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multicountry, multicenter, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with a durvalumab-based regimen as part of routine clinical practice or early access program (EAP). The study design will include primary and secondary data collection. The primary objective of this study is to evaluate the effectiveness of durvalumab-based regimens in real-world settings as measured by real-world overall survival. Other endpoints include demographics, clinical characteristics, clinically significant events of interest, treatment patterns, concomitant medications, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, recurrence-free survival, and time to treatment recurrence).
肺動脈性高血圧症（PAH）患者を対象としたソタテルセプト（MK-7962）の臨床試験（MK-7962-024）
Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. The goal of the study is to learn: * What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial. * About the safety of sotatercept and if people tolerate it
アルツハイマー病患者を対象としたメビダレン（LY3154207）の研究
The main purpose of this study is to look at how safe the study drug (mevidalen) is and whether it works to alleviate symptoms when given to people with mild to moderate Alzheimer Disease (AD) dementia. This is done by looking at participants: thinking and memory (cognition), everyday activities and sleep, AD symptoms, physical activity, irritability or anxiety. The study is expected to last approximately 26 weeks and may include up to 14 visits.
結節性痒疹患者におけるポボルシチニブの有効性と安全性を評価する試験（STOP-PN2）
この研究の目的は、結節性痒疹の参加者における痒みと皮膚病変に対するポボルシチニブの効果を評価することです。
クローン病：中等度から重度の活動性クローン病の小児患者におけるウパダシチニブの有効性、安全性および薬物動態
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
虚血性脳卒中患者および経口抗凝固薬の直接服用患者における静脈内血栓溶解療法の安全性と有効性
DO-IT is an international, multicenter, prospective, two-arm, randomized, open label, blinded endpoint superiority trial determining the safety and efficacy of intravenous thrombolysis (IVT) in participants experiencing an acute ischemic stroke (AIS) with recent (within the last 48 hours) intake of direct oral anticoagulant (DOAC). For this purpose, 906 adult participants experiencing an AIS with recent DOAC intake will be enrolled at several high-volume international stroke centers and randomly assigned in a ratio of 1:1 to one of two treatment arms: (1) IVT and standard of care/best medical treatment or (2) standard of care/best medical treatment. The DO-IT trial is a definitive test of the hypothesis that IVT is superior to standard of care for achieving better outcome at 90 days in AIS participants with recent DOAC intake.
再発性/難治性（R/R）B細胞NHL患者における単剤療法としてのスロバタミグ（AZD0486）
This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of Surovatamig (AZD0486) monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for LBCL.