治験一覧
8,963 件中 1361〜1380 件を表示
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.
中等度から重度の活動性潰瘍性大腸炎患者を対象としたJNJ-77242113の研究
The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.
KRAS G12C変異を有する未治療の進行性または転移性非小細胞肺癌患者におけるジバラシブ単剤または他の抗癌剤との併用の安全性、活性および薬物動態を評価する研究
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
慢性腎臓病および高タンパク尿を有する患者におけるジボテンタン/ダパグリフロジンとダパグリフロジンの有効性、安全性および忍容性を比較する試験(ZENITH高タンパク尿)
This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria
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
経口ヒアルロン酸(UltraHA®)が膝機能に及ぼす影響
This clinical trial aims to clarify the effect of UltraHA® on knee joint conditions.
成人被験者におけるボトックス注射による有害事象および咬筋突出の変化を評価する研究
The masseter muscle is one of the muscles in the lower face used for chewing. Prominence of the masseter muscle can appear as a widened and square lower face shape, which is an aesthetic concern for individuals who prefer a narrower and more ovoid lower face shape. Treatments are available for masseter muscle prominence (MMP), but researchers are looking for new non-surgical treatments. This study will assess adverse events and effectiveness of BOTOX in adult participants with MMP. BOTOX is being investigated for the treatment of MMP. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is 1 in 5 chance that participants will be assigned to placebo. Around 250 adult participants with MMP will be enrolled in the study at approximately 20 sites in Japan. Participants will receive either BOTOX or Placebo administered as 6 intramuscular injections to each masseter muscle on Day 1. Participants who are eligible for retreatment will be given BOTOX on either Day 180, 210, 240, or 270 and will be followed until approximately Day 360. There may be a 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, facial photography, checking for side effects and completing questionnaires.
MIBC患者に対するペンブロリズマブとEVの併用放射線療法(PEVRAD)
This study is designed to assess the efficacy and safety of induction therapy with MK-3475 and ASG-22CE and radiation therapy with MK-3475 in patients with cT2-4aN0M0 muscle invasive bladder cancer who are unfit for or refuse radical cystectomy.
食物アレルギーにおけるリゲリズマブの長期継続試験
This was an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who completed a ligelizumab Phase III study in food allergy.
中等度から重度のアトピー性皮膚炎患者(12歳以上)を対象とした皮下投与アムリテリマブの安全性と有効性を評価するオープンラベル長期試験
This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 284 weeks, including: * A screening period of up to 2 to 4 weeks * An open label treatment period of up to 268 weeks (approximately 5 years) * A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264) The planned number of visits will be 35 visits.
寒冷凝集素症リアルワールドエビデンスレジストリ
This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 \[NCT02502903,CAD patients\], BIVV009-03/EFC16215 \[NCT03347396\], and BIVV009-04/EFC16216 \[NCT03347422\]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.
慢性リンパ性白血病(CLL)/小リンパ球性リンパ腫(SLL)の一次治療(1L)におけるネムタブルチニブ(MK-1026)と対照薬(治験担当医師の選択によるイブルチニブまたはアカラブルチニブ)の比較試験(MK-1026-011/BELLWAVE-011)
The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.
ジェネンテックおよび/またはF.ホフマン・ラ・ロシュがスポンサーとなった研究に以前参加した参加者のためのロールオーバー研究
The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP\[s\]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.
高コレステロール血症およびスタチン不耐症患者を対象としたK-877(ペマフィブラート)の第III相確認試験
To investigate the efficacy and safety of K-877 Extended Release 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with Statin Intolerant\* Hypercholesterolemia,using placebo as a controll. \*Statin Intolerant: Adverse events associated with statin use that cause unacceptable disturbances in the user's daily life, resulting in drug discontinuation or dose reduction.
健康な成人を対象としたTAS3731の研究
To evaluate the safety of single and repeated administration of TAS3731.
メトホルミンで十分にコントロールされていない2型糖尿病患者におけるオルフォルグリプロン(LY3502970)とセマグルチドの比較試験
The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks.
CKDにおける貧血研究:新規PHIダプロデュスタットによる赤血球産生 - 小児(ASCEND-P)
This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated with chronic kidney disease (CKD) incorporating 2 independent sub-trials (Non dialysis \[ND\] and Dialysis \[D\]). This study will enroll participants with anemia associated with CKD, in 2 distinct sub-populations differing only by their CKD stage and dialysis requirement (ND: CKD stage 3 to 5 not yet receiving dialysis and D: CKD stage 5d undergoing peritoneal dialysis \[PD\] or hemodialysis \[HD\]). The maximum duration of the study will be approximately 60 weeks, including Screening period (up to 4 weeks), treatment period (52 weeks), and follow-up period (4 weeks). Outcome measures are identical for the ND and D sub-trials, but will be separately assessed in each sub- trials, overall and within each age subgroups (12 to less than \[\<\] 18 years, 6 to \<12 years, 2 to \<6 years, and 3 months to \<2 years). Except for PK and dose change, which is within each age group only.
中等度から重度の全身性重症筋無力症の小児研究参加者におけるロザノリキシズマブの研究
The purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to \<18 years with generalized Myasthenia Gravis (gMG).
特発性肺線維症患者におけるBMS-986278の有効性、安全性、忍容性を評価する研究
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
遺伝性網膜疾患の世界患者登録
The purpose of this study is to better understand the natural history of Inherited Retinal Disease (IRD) and help inform patient management.