治験一覧
8,963 件中 1401〜1420 件を表示
ループス腎炎の青年および小児患者におけるボクロスポリン長期治療
The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescent and pediatric subjects with lupus nephritis.
肺炎球菌感染症リスク増加成人におけるV116の安全性と免疫原性（V116-008）
The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination within each vaccination group separately.
活動性シェーグレン症候群の成人患者におけるデュクラバシチニブの有効性と安全性を評価する研究
この研究の目的は、活動性シェーグレン症候群の成人参加者におけるデュクラバシチニブの2回投与の安全性と有効性を評価することです。
過体重または肥満の被験者におけるAZD6234の反復投与後の安全性、忍容性、薬物動態および薬力学を評価する研究
A study in healthy male and female participants of non-childbearing and childbearing potential who have overweight or obesity
ブライトライン4：脱分化型脂肪肉腫と呼ばれる癌患者におけるブリギマドリンの忍容性を検証する研究
This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumours are positive for MDM2. The purpose of this study is to find out whether a medicine called brigimadlin (BI 907828) is tolerated by and helps people with DDLPS. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Participants take brigimadlin as a tablet once every 3 weeks. Participants may continue to take brigimadlin as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check participants' health and take note of any unwanted effects. The doctors also regularly check tumour size.
ヒドロキシウレア（MK-3543-006）に対する反応不十分または不耐性を有する本態性血小板血症患者におけるボメデムスタット（IMG-7289/MK-3543）と最善の利用可能な治療法（BAT）の比較試験
This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).
早期大腸がんの光学的診断に関するウェブベースの学習モジュール
International guidelines recommend deciding the treatment of colorectal lesions based on the estimated histology by endoscopic optical diagnosis. However, the theoretical and practical knowledge on optical diagnosis is not widely expanded The mail goal of this randomised controlled trial is to compare the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps \> 20 mm assessed in routine colonoscopies of gastroenterologists attending a e-learning module (intervention group) vs gastroenterologists who do not (control group) The main questions the study aims to answer are: * Is the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module? * Is the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps ≥ 20 mm assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module? * In lesions with submucosal invasion, is the en bloc and complete resection rate (R0) increased in those gastroenterologists participating in the e-learning module? * In lesions referred to surgery, is the pooled benign polyps rate decreased in those gastroenterologists participating in the e-learning module? * In lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection), is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in those gastroenterologists participating in the e-learning module? * In lesions treated with piecemeal endoscopic resection, is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in those gastroenterologists participating in the e-learning module? * Is the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures increased after participating in the e-learning module? The participants (or subjects of study) are gastroenterologists. They will be randomised to do the e-learning course (intervention group) or not (control group). Researchers will compare clinical outcomes of gastroenterologists participating in the e-learning module vs gastroenterologists not participating in the e-learning module to see if: * the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps \> 20 mm assessed in routine colonoscopies is increased. * the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps \> 20 mm is increased. * the en bloc and complete resection rate (R0) is increased in lesions with submucosal invasion. * the pooled benign polyps rate decreased in lesions referred to surgery. * the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection). * the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in lesions treated with piecemeal endoscopic resection. * the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures after participating is increased.
ナルコレプシー1型患者を対象としたTAK-861の研究
The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.
肥満疾患を有する日本人成人を対象とした、1日1回経口投与のオルフォルグリプロン（LY3502970）の試験
The main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.
小児を対象とした全身性エリテマトーデス治療における静脈内アニフロルマブの有効性と安全性に関する試験
A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
MagnetisMM-32：多発性骨髄腫（MM）患者を対象に、他の治療（抗CD38抗体とレナリドミドによる前治療を含む）後に再発した患者を対象とした、エルラナタマブと呼ばれる治験薬について検討する試験
この研究の目的は、エルラナタマブと呼ばれる治験薬について理解を深めることです。この研究は、MM（がんの一種）の治療におけるエルラナタマブと他の薬剤を比較することを目的としています。 この研究では、以下の条件を満たす参加者を募集しています。 * 18歳以上でMMを患っていること。 * 過去にMMの治療を受けたことがあること。 * MMが再発したか、直近の治療に反応がなかったこと。 参加者の半数はエルラナタマブを投与されます。残りの半数は、治験担当医が選択した併用療法を受けます。選択された併用療法には、MMの治療に一般的に使用される2～3種類の薬剤が含まれます。 エルラナタマブは、治験実施医療機関で週1回程度皮下注射されます。治験の進行に伴い、注射回数が減る可能性があります。 併用療法における薬剤は、経口（自宅または治験実施医療機関）で服用し、以下のいずれかの方法で投与されます。 * 治験実施医療機関における皮下注射 * 治験実施医療機関における静脈注射 これらの薬剤の服用回数は、治験担当医師が選択した併用療法によって異なります。 参加者は、MMが反応しなくなるまで、エルラナタマブまたは併用療法を継続して受けることができます。治験チームは、治験実施医療機関への定期的な通院中に、各参加者の治験治療の経過を観察します。治験治療終了後も、電話連絡（または来院）により参加者のフォローアップを継続します。 本研究では、エルラナタマブを投与された患者と併用療法を受けた患者の経験を比較します。これにより、エルラナタマブの安全性と有効性について理解を深めることができます。
TEZSPIRE（テゼペルマブ）喘息に関する日本市販後調査（PMS）
The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire. 1. Development of related AEs 2. Contributing factors possibly having an impact on the safety and effectiveness 3. Development of unexpected related AEs
Evusheld Japan PMS_日本における製造販売後調査（PMS）
To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.
CLDN6陽性局所進行性または転移性固形腫瘍患者を対象としたSAIL66の第1相試験
This is a Phase 1 dose-escalation and expansion study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of SAIL66 in patients with CLDN6-positive locally advanced or metastatic solid tumors.
クレアリーフ：BI 1291583を用いた以前の研究に参加した気管支拡張症患者におけるBI 1291583の長期治療を検証する研究
This study is open to adults aged 18 years and older with bronchiectasis. People can join the study if they were previously enrolled in another study with BI 1291583 (1397-0012: Airleafᵀᴹ or 1397-0013 Clairaflyᵀᴹ). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis, an inflammatory lung condition. The investigators also want to know how well people with this condition can tolerate BI 1291583 in the long term. Participants take a low, medium, or high dose of BI 1291583 as a tablet once a day for up to 1 year. Participants who were taking placebo in the AirleafTM or ClairaflyTM study are put into the BI 1291583 dosage groups randomly, which means by chance. Placebo tablets look like BI1291583 but do not contain any medicine. Participants who were taking BI 1291583 in the AirleafTM or ClairaflyTM study continue to take the same dose. Participants visit the study site 10 times and get 4 phone calls from the site staff. During the visits, the doctors collect information on any health problems of the participants. The doctors also check whether BI 1291583 helps reduce the symptoms of bronchiectasis.
X連鎖性網膜色素変性症の日本人患者に対するAAV5-hRKp.RPGRの治療研究
The purpose of the study is to assess the safety and tolerability of bilateral subretinal delivery of adeno-associated virus vector with a serotype 5 capsid human rhodopsin kinase promoter. retinitis pigmentosa guanosine triphosphatase regulator (AAV5-hRKp.RPGR).
B細胞悪性腫瘍の成人患者における有害事象、疾患活動性の変化、および経口ABBV-101の体内移動を評価する研究
Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) non-Hodgkin's lymphomas: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed. ABBV-101 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-101 and a dose expansion phase to determine the change in disease activity in participants with first line treatment (1L), second line or later of treatment (2L)+ CLL/SLL or third line or later of treatment (3L) non-GCB DLBCL. Approximately 340 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating oral doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 88 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101, as part of the approximately 88 month study duration . There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.
特定の進行固形腫瘍適応症を有する成人被験者におけるABBV-400静脈内（IV）投与における有害事象および疾患活動性の変化を評価する試験
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Cohorts 1-8 receive ABBV-400 alone (monotherapy) followed by a safety follow-up period. Cohort 9 receives ABBV-400 in combination with a strong CYP3A3 inhibitor (ITZ) followed by a safety follow-up period. Approximately 285 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive \[HR+\]/HER2-breast cancer \[BC\]), head and neck squamous-cell-carcinoma (HNSCC), Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer, or advanced solid tumors, will be enrolled in the study in approximately 54 sites worldwide. In cohorts 1-8, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, HNSCC, and PROC/primary peritoneal/fallopian tube cancer will receive intravenous (IV) ABBV-400 monotherapy and in cohort 9 participants will receive intravenous (IV) ABBV-400 and an oral solution of ITZ, for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
高LDLコレステロール血症患者におけるETC-1002の長期試験
A Multicenter, Open-label Study to assess the safety and efficacy of ETC-1002 at 180 mg administered for 52 weeks in patients with hyper-LDL cholesterolemia
非肝硬変性非アルコール性脂肪性肝炎（線維化を伴う）のPNPLA3 148Mリスクアレル保有者におけるAZD2693の評価試験
A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele