治験一覧
8,963 件中 2461〜2480 件を表示
好酸球性表現型を伴う重症喘息患者を対象としたGSK3511294（デペモキマブ）の研究
This study will assess the efficacy and safety of GSK3511294 (Depemokimab) as an adjunctive therapy in participants with severe uncontrolled asthma with an eosinophilic phenotype.
腎細胞癌患者の治療に使用されるカボザンチニブに関する調査
This study is a survey in Japan of Cabozantinib tablets used to treat people with a type of kidney cancer called renal cell carcinoma. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects from Cabozantinib. During the study, participants with renal cell carcinoma will take Cabozantinib tablets according to their clinic's standard practice. The study doctors will check for side effects from Cabozantinib for 26 weeks.
フォシーガHF一般使用成績調査
To capture safety when Forxiga is administered to patients with HF in clinical practice after launch.
神経芽腫を含む固形腫瘍を有する小児および若年成人患者を対象とした、アベマシクリブ（LY2835219）と他の抗がん剤の併用試験
The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment. For each participant, the study is estimated to last up to 2 years.
急性虚血性脳卒中患者における同種ヒト歯髄幹細胞JTR-161の有効性および安全性を評価するための無作為化プラセボ対照多施設共同試験（J-REPAIR）
The objective of this study is to evaluate the safety and efficacy of a single intravenous administration of JTR-161 (allogeneic stem cell product derived from the dental pulp of healthy adult humans) to patients with acute ischemic stroke. This study is comprised of 3 cohorts and conducted in the order of Cohort 1, Cohort 2 and Cohort 3. Cohort 1 Arm-1: JTR-161, 1 × 10\^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects The Data and Safety Monitoring Board (DSMB) and the Sponsor will decide whether Cohort 2 can be initiated or not. Cohort 2 Arm-1: JTR-161, 3 × 10\^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects DSMB and the Sponsor will decide whether Cohort 3 can be initiated or not and the dose of JTR-161 in Cohort 3. Cohort 3 Arm-1: JTR-161, 1 × 10\^8 cells/subject or 3 × 10\^8 cells/subject, 30 subjects Arm-2: Placebo, 30 subjects
持続性/慢性原発性免疫血小板減少症の成人患者におけるTAK-079の試験
Primary immune thrombocytopenia (ITP) is a rare disease that results in low levels of platelets - the cells that help blood clot. The main aim of the study is to check for side effects from taking TAK-079 at three different dose levels. Another aim is to learn if TAK-079 can increase the platelet count in people with ITP. In addition to receiving stable background therapy for ITP, participants will receive an injection of either TAK-079 or a placebo once a week for 2 months. A placebo looks like TAK-079 but will not have any medicine in it. After treatment, all participants will be followed-up for another 2 months. Then, participants who received TAK-079 will continue to be followed-up for an extra 4 months. Participants who received the placebo and would like to receive TAK-079 may be able to do this in an extension period in the study.
PD-L1発現率50%未満の非扁平上皮非小細胞肺癌の高齢患者に対するペムブロリズマブとペメトレキセドの併用療法：CJLSG1901
To evaluate the efficacy and safety of Pembrolizumab + Pemetrexed in elderly patients with non-squamous non-small cell lung cancer with Programmed cell death (PD) -ligand1 (L1) tumor proportion score (TPS) of less than 50%.
既治療の慢性リンパ性白血病（CLL）/小リンパ球性リンパ腫（SLL）患者を対象としたLOXO-305（ピルトブルチニブ）と治験担当医師の選択（イデラリシブ＋リツキシマブまたはベンダムスチン＋リツキシマブ）の比較試験
This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.
IgA腎症に対するVIS649の安全性および有効性に関する研究
The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)
B型肝炎ウイルスとD型肝炎ウイルスの重複感染者を対象としたJNJ-73763989 + Nucleos(t)Ideアナログの研究
The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.
線維化を伴う非アルコール性脂肪性肝炎（NASH）を解決するための代謝介入（MIRNA）
The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).
12～17歳の慢性片頭痛患者を対象としたガルカネズマブ（LY2951742）の試験
The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
トレラグリプチン錠の特定薬剤使用調査「重度の腎機能障害または末期腎不全を伴う2型糖尿病患者における長期使用に関する調査」
The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.
中等度から重度の活動性全身性エリテマトーデスを有する成人被験者を対象とした、経口エルスブルチニブカプセルおよび経口ウパダシチニブ錠の単独または併用投与の安全性に関する研究（ABBV-599）による疾患状態の変化の評価
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms. ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 100 sites worldwide. Participants will receive the following for up to 56 weeks: Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study. Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of 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.
HSCT-TMAの小児参加者におけるラブリズマブの研究
This study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab administered by intravenous infusion to pediatric participants, from 1 month to \< 18 years of age, with HSCT-TMA. The treatment period is 26 weeks, followed by a 26-week off-treatment follow-up period.
ER（+）HER2（-）進行乳がん患者に対する第一選択療法としてのアムセネストラント（SAR439859）とパルボシクリブの併用
Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: * To compare the overall survival in both treatment arms. * To evaluate the objective response rate in both treatment arms. * To evaluate the duration of response in both treatment arms. * To evaluate the clinical benefit rate in both treatment arms. * To evaluate progression-free survival on next line of therapy. * To evaluate the pharmacokinetics of amcenestrant, and palbociclib. * To evaluate health-related quality of life in both treatment arms. * To evaluate the time to first chemotherapy in both treatment arms. * To evaluate safety in both treatment arms.
COPDにおける早期介入の有効性
This study aims to evaluate the time to escalation to triple therapy among the Japanese Chronic obstructive pulmonary disease (COPD) patients newly initiating therapy with a combination of Olodaterol and Tiotropium (herein referred to as Tio/Olo) using real world data.
MINIRINMELT® OD錠（夜間頻尿）に関する特定薬物使用結果調査（長期使用）
To investigate the incidence and risk factors of desmopressin-induced hyponatremia during long-term treatment (1 year \[52 weeks\]) of MINIRINMELT orally disintegrating (OD) tablets 25μg/50μg (drug) for nocturia caused by nocturnal polyuria in men in daily clinical practice, and to confirm the compliance with proper use of this drug in clinical practice and to investigate the effectiveness of risk minimization activities.
MagnetisMM-3：少なくとも1種類のPI、1種類のIMiD、および1種類の抗CD38 mAbに抵抗性の多発性骨髄腫患者を対象とした、エルラナタマブ（PF-06863135）単剤療法の試験
The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.
治癒目的の手術を受けた新規子宮内膜癌患者を対象とした、放射線療法の有無にかかわらず補助化学療法とペムブロリズマブ（MK-3475）の併用療法に関する試験（MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053）
The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.