治験一覧
8,963 件中 2421〜2440 件を表示
急性心筋梗塞疑い患者におけるセラトグレル転帰試験
This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.
真性多血症患者を対象とした安全性評価研究
This is PhaseI Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of PPMX-T003 in Polycythemia Vera
アシミニブロールオーバー試験
This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
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.
16歳から40歳までの健康な被験者を対象とした、mRNA-1647サイトメガロウイルス(CMV)ワクチンの有効性、安全性、免疫原性を評価する研究
The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension substudy is to extend the observation period of the main study and to assess the longer-term immunogenicity, efficacy, and safety of the mRNA-1647 vaccine against primary CMV infection in healthy females who were CMV-seronegative at Baseline of the mRNA-1647-P301 main study (including participants who remain CMV-seronegative upon entry into the extension substudy and participants who seroconverted during the main study). The extension substudy will also evaluate the immune persistence and safety of mRNA-1647 in a subset of female participants who were CMV-seropositive at Baseline of the main study. No interventional vaccine will be administered in the extension substudy.
原発性胆汁性胆管炎による掻痒感を有する患者における治験薬ボリキシバットの有効性と安全性を評価する研究
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.
中等度から重度の潰瘍性大腸炎(UC)の小児および10代の若者を対象としたベドリズマブの研究
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.
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.
濾胞性リンパ腫患者におけるレナリドミドと併用したモズネツズマブの有効性と安全性を、レナリドミドと併用したリツキシマブと比較評価する試験、およびレナリドミドと併用したモズネツズマブの米国における拡大試験
This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy.
プルバック圧力勾配(PPG)グローバルレジストリ
The purpose of this study is to determine the predictive capacity of the Pullback Pressure Gradient (PPG) index for post-PCI FFR and to determine the impact of the PPG index on clinical decision making about revascularization and on clinical outcomes.
中等度から重度の尋常性乾癬の小児患者におけるデュクラバシチニブの薬物濃度、有効性および安全性を評価する研究
The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric participants aged 4 to \<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \<18 years) and Cohort 2 (age 4 to \<12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in pediatric participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in pediatric participants with psoriasis who have completed Parts A or B of the study.
多発性骨髄腫の成人患者を対象とした、静脈内(IV)レムゾパルリマブ単独投与(経口/IVデキサメタゾン併用または非併用)および経口/IV/皮下抗骨髄腫療法との併用における有害事象および疾患活動性の変化を評価する研究
Multiple myeloma (MM) accounts for more than 10% of all blood cancers and 1% of all cancers. The purpose of this study is to assess how safe lemzoparlimab is and how lemzoparlimab moves through the body of adult participants with MM when given with or without dexamethasone, and in combination with other anti-myeloma regimens. Adverse events and change in disease activity will be assessed. Lemzoparlimab is an investigational drug being developed for the treatment of relapsed/refractory (R/R) MM. Study doctors put the participants in groups called treatment arms. Two different dose levels of lemzoparlimab will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of lemzoparlimab, followed by a dose expansion phase to confirm the dose. Approximately 163 adult participants with R/R MM will be enrolled in the study in approximately 60 sites worldwide. In the Dose Escalation arms, participants will receive intravenous (IV) lemzoparlimab with or without dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or subcutaneous (SC) daratumumab in 28-day cycles. In the Dose Expansion arms, participants will receive lemzoparlimab (IV) alone or with dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or daratumumab (SC) in 28-day cycles. 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.
日本人2型糖尿病患者におけるデュラグルチド(LY2189265)の2つの用量に関する研究
The purpose of this study is to evaluate the efficacy and safety of 2 doses of dulaglutide in Japanese participants with type 2 diabetes. The study duration is approximately 58 weeks.
全身性重症筋無力症患者におけるサトラリズマブの有効性、安全性、薬物動態および薬力学を評価する試験
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).
日本における乾癬の治療パターンと臨床転帰に関する研究
The purpose of this study is to understand current real-world treatment patterns and clinical outcomes, reasons for switching treatment, and participant characteristics using each systemic psoriasis treatment in Japan.
急性骨髄性白血病患者を対象に、アザシチジン皮下投与または静脈内投与とベネトクラクス経口投与を併用してレムゾパルリマブを静脈内投与した場合、および骨髄異形成症候群患者を対象に、アザシチジン単独またはベネトクラクス併用でレムゾパルリマブを静脈内投与した場合の有害事象および体内動態を評価する研究
Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo intensive chemotherapy, the current standard of care. This study is to evaluate how safe lemzoparlimab is and how it moves within the body when used along with azacitidine and/or venetoclax in adult participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Adverse events and maximum tolerated dose (MTD) of lemzoparlimab will be assessed. Lemzoparlimab (TJ011133) is being evaluated in combination with azacitidine and venetoclax for the treatment of acute myeloid leukemia (AML) and with azacitidine with/without venetoclax for myelodysplastic syndrome (MDS). Study doctors place the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of AML or MDS will be enrolled. Around 80 participants will be enrolled in the study in approximately 50 sites worldwide. Participants will receive lemzoparlimab (IV) once weekly (Q1W), venetoclax oral tablets once daily (QD) for 28 days (AML participants) or 14 days (MDS participants) and Azacitidine by SC or IV route QD for 7 days of each 28-day cycle. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.
上肢痙縮の成人被験者における IPN10200 の安全性と有効性を評価する研究。
The purpose of the study is to assess the safety and efficacy of increasing doses of IPN10200 with the aim to evaluate the Pharmacodynamics (PD) profile of IPN10200 and to establish the total IPN10200 doses(s) that offer the best efficacy/safety profile when used for the treatment of Adult upper limb (AUL) spasticity.
中等度から重度の活動性潰瘍性大腸炎患者におけるエファバロイキン アルファの安全性と有効性
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.
成人非小細胞肺癌患者を対象とした二次治療としてのカプマチニブとオシメルチニブの併用療法の有効性および安全性を評価する研究
This study aimed to evaluate the anticancer activity of capmatinib in combination with osimertinib compared to platinum-pemetrexed based doublet chemotherapy as second line treatment in patients with advanced or metastatic non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation, T790M negative, mesenchymal-to-epithelial transition factor (MET) amplified who progressed following EGFR tyrosine kinase inhibitors (TKIs).
健康な日本人男性を対象としたJNJ-40411813の研究
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single dose and multiple dose administrations of JNJ-40411813 in Japanese healthy adult male participants.