治験一覧
8,963 件中 2121〜2140 件を表示
未治療のAML、MDSまたはCMML患者におけるアザシチジン単独またはグラスデギブ併用療法の評価に関するB1371019（NCT03416179）およびB1371012（NCT02367456）の継続試験
An open-label study available to all eligible participants from Study B1371019 and participants originating from Study B1371012 continuing on study intervention with azacitidine with or without glasdegib.
過体重または肥満の人におけるセマグルチド錠の1日1回服用の効果を調査する研究調査（OASIS 1）
This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation. Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning In addition to taking the medicine, participants will have talks with study staff about: * healthy food choices * how to be more physically active * what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits. Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.
ABC-HCC試験：中等度肝細胞癌におけるアテゾリズマブ＋ベバシズマブ併用療法と経動脈化学塞栓療法（TACE）の比較
The ABC-HCC trial is a Phase IIIb, randomised, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab plus bevacizumab versus TACE in patients with intermediate-stage HCC. Approximately 434 patients in two arms of treatment will be enrolled.
パルボシクリブとレトロゾールを併用したHR+/HER2-進行乳がんの日本人患者の全生存率を評価する研究
This is a retrospective, multicenter, observational study in Japan. The primary objective is to evaluate overall survival (OS) in Japanese patients with HR+/HER2- advanced breast cancer who have been treated with palbociclib plus letrozole. This observational study was planned as follow-up study of Japanese phase 2 study of palbociclib (NCT01684215, phase 2 portion of A5481010 study).
パルボシクリブと内分泌療法併用療法または内分泌療法単剤療法を受けたHR+/HER2-進行乳がんの日本人患者における患者報告アウトカム（PRO）および身体活動を評価する研究
The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC). Patients will be enrolled into either palbociclib plus endocrine therapy group (Group 1) or endocrine monotherapy group (Group 2) based on the discretion of the treating physician under routine clinical practice. Total target number of patients is approximately one-hundred in this study (About 50 patients in each group). Enrolled patients will download a smartphone-based application for electronic PRO (ePRO), be provided access to and trained on the use of the application to complete baseline, weekly, and cycle-based assessments for 6 cycles (24 weeks). In addition, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).
健康な日本人成人を対象としたTAK-019の臨床試験（COVID-19）
TAK-019 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-019 can protect people from Covid-19 and to check for side effects from TAK-019. At the first visit, the study doctor will check if each person can take part. Those who can take part will be chosen for 1 of 2 treatments by chance. Participants will either receive an injection of TAK-019 or a placebo in their arm. In this study, a placebo will look like the TAK-019 vaccine but will not have any medicine in it. 3 times as many participants will receive TAK-019 than placebo. Participants will receive 2 injections of TAK-019 or placebo, 21 days apart. Participants will be asked to record their temperature and any medical problems in an electronic diary for up to 7 days after each injection. During the study, participants will visit the clinic for regular check-ups, blood tests, and sometimes for nose swab samples. When all participants have attended a clinic visit 28 days after their 2nd injection, the study sponsor (Takeda) will check how many participants have made enough antibodies to protect them against Covid-19. The participants will stay in the study for up to 12 months after they have had their 2nd injection. During this time, the study doctors will continue to check how many participants have made enough antibodies to protect them against Covid-19. Also, they will check if participants have any more side effects from TAK-019 or the placebo.
MLL再構成またはNPM1変異の有無にかかわらず再発性/難治性AML/ALLに対するDSP-5336の研究
A phase 1/2 dose escalation / dose expansion study of Enzomenib (DSP-5336) in adult patients with acute leukemia.
新型コロナウイルス感染症の症状が確認された同居家族と接触した成人における、新型コロナウイルス感染症予防のための経口治療薬の可能性に関する研究
The purpose of this clinical trial is to learn whether the study medicine prevent symptoms of COVID-19 in adults who have been exposed to household member(s) with a confirmed symptomatic COVID-19 infection. All participants in the study will receive treatment for COVID-19 as needed, based on their regular doctor's recommendation. Two-thirds of participants will also receive two study medicines (PF-07321332 and ritonavir) by mouth twice a day for either five or ten days. We will compare the experiences of people receiving the study medicines to those of the people who do not. This will help us determine if the study medicines are safe and effective
短腸症候群におけるアプラグルチドの長期安全性を評価するためのオープンラベル延長試験。
The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.
診療報酬請求データベースを用いた日本人患者におけるリバーロキサバンによる静脈血栓塞栓症（VTE）治療に関する研究
This is an observational study in which data from the past is collected for a treatment which is already available for doctors to prescribe for venous thromboembolism (VTE). VTE is a condition in which blood clots form in veins, which can lead to disability and death. This study looks at the bleeding risk in Japanese patients who are already receiving long-term rivaroxaban treatment for their VTE. Some common causes of VTE are surgery, lack of movement, being bed-ridden and cancer. VTE that is caused by cancer is called cancer-associated venous thromboembolism (Ca-VTE). The study treatment, rivaroxaban, is a blood thinner prescribed by doctors to help treat conditions like VTE. By thinning the blood, rivaroxaban can help keep blood flowing normally and prevent blood clots. But, rivaroxaban can lead to increased bleeding in some people. There have been studies done in which participants with VTE and Ca-VTE received treatment with rivaroxaban for a long period of time. The overall results of those studies showed that long-term treatment with rivaroxaban helped prevent blood clots in those participants. Some of the participants had increased bleeding after this long-term treatment, while some did not. Participants with certain types of cancers, such as Ca-VTE, also had an increased risk of bleeding. These studies, however, did not include Japanese participants. So, the researchers in this study want to learn more about the risk of bleeding in Japanese patients with VTE or Ca-VTE who receive long-term treatment with rivaroxaban. To do this, the researchers plan to use a medical database to find information for patients with VTE and Ca-VTE who have already been taking rivaroxaban for their condition. This database will help the researchers collect information about the bleeding risk of long-term rivaroxaban treatment in Japanese patients. In this study, the researchers will learn more about: * the characteristics of patients with VTE who are treated with rivaroxaban for a period of less than 3 months to more than 1 year * the bleeding risk for all of the patients throughout the study * the bleeding risk for the patients with Ca-VTE throughout the study * the cause of any bleeding that happens The researchers will follow and record these results for Japanese patients from October 2015 to December 2020.
活動性全身性エリテマトーデス（SLE）患者におけるアフィメトランとプラセボの有効性と安全性を比較評価する試験
The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.
腹膜透析を受けている高リン血症患者におけるKHK7791の臨床試験
To evaluate the efficacy of KHK7791 by comparing changes in serum phosphorus levels from baseline values between peritoneal dialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 for 8 weeks and those receiving placebo.
過去2年間に尿路感染症の病歴を有する60歳以上の成人における侵襲性腸管外病原性大腸菌感染症の予防を目的とした9価腸管外病原性大腸菌ワクチン（ExPEC9V）接種の研究
The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the prevention of the first invasive extraintestinal pathogenic Escherichia coli disease (IED) event caused by ExPEC9V O-serotypes.
円形脱毛症患者を対象としたJNJ-64304500の研究
The purpose of this study is to evaluate the clinical response of 22 weeks of study intervention with JNJ-64304500, compared with placebo, in participants with moderate to severe alopecia areata (AA).
胃癌治療歴のある患者におけるツサミタマブ・ラブタンシン（SAR408701）とラムシルマブの併用
Primary Objectives: Part 1: to confirm the recommended tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma population Part 2: to assess the antitumor activity of tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or GEJ adenocarcinoma Secondary Objectives: * To assess safety and tolerability * To assess durability of response (DOR) * To assess progression-free survival (PFS) * To assess the disease control rate (DCR) * To assess the pharmacokinetics (PK) * To assess the immunogenicity
16歳以上の先天性副腎過形成患者におけるクロノコルトと標準的なヒドロコルチゾン補充療法の比較
This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal Hyperplasia.
B細胞悪性腫瘍患者を対象としたBGB-16673の用量漸増および拡大試験
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
日本人AOSD患者におけるカナキヌマブの有効性と安全性に関する研究
This is a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Adult Onset Still's Disease (AOSD). Interim analysis (IA) data at Week 28 and 48 from this study supports a registration submission of canakinumab in the indication of Adult still's disease (ASD) in Japan.
手術不能または転移性HR陽性HER2陰性乳がん患者で、1～2種類の全身化学療法による治療を受けた患者を対象とした、Dato-DXdと治験担当医選択化学療法（ICC）を比較する第3相非盲検ランダム化試験（TROPION-Breast01）
The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.
他の治療を受けた多発性骨髄腫患者における、エルラナタマブ単独とダラツムマブとの併用による治験薬について知るための研究
この臨床試験の目的は、(1) BCMA-CD3二重特異性抗体であるエルラナタマブが、ダラツムマブ、ポマリドミド、デキサメタゾンを含む併用療法と比較して、多発性骨髄腫患者により高い効果をもたらすかどうかを検討すること、および(2) 抗CD38モノクローナル抗体であるダラツムマブと併用した場合のエルラナタマブの安全性と有効性を検討することです。レナリドミドを含む前治療歴のある多発性骨髄腫患者が本試験に登録されます。 本試験のパート1では、異なる用量のエルラナタマブとダラツムマブの併用における安全性と有効性を評価します。 本試験のパート2に参加する患者は、エルラナタマブ単独、エルラナタマブとダラツムマブの併用、またはダラツムマブ、ポマリドミド、デキサメタゾンのいずれかの投与群に無作為に割り付けられます。パート2では、(1) エルラナタマブ単独とダラツムマブ、ポマリドミド、デキサメタゾンの併用、および(2) エルラナタマブとダラツムマブの併用の安全性と有効性を評価します。 パート3では、エルラナタマブ単独またはダラツムマブとの併用で治療を受けた患者における感染予防対策の強化の効果を評価します。 本試験に参加するすべての患者は、病状の進行、許容できない副作用の発現、または試験への参加中止を選択するまで、試験治療を受けます。