治験一覧
8,963 件中 4781〜4800 件を表示
自己免疫性肺胞蛋白症における吸入モルグラモスチム（rhGM-CSF）の有効性と安全性
This study evaluates inhaled molgramostim (recombinant human granulocyte macrophage-colony stimulating factor \[rhGM-CSF\]) in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) patients. A third of the patients will receive inhaled molgramostim once daily for 24 weeks, a third will receive inhaled molgramostim intermittently (7 days on, 7 days off) for 24 weeks and a third will receive inhaled matching placebo for 24 weeks.
FMS様チロシンキナーゼ3（FLT3/ITD）急性骨髄性白血病（AML）の初回完全寛解患者を対象に、導入療法／地固め療法後の維持療法としてASP2215（ギルテリチニブ）を投与する研究
The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who were randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a two-year period.
再発性または難治性の末梢性T細胞リンパ腫および皮膚T細胞リンパ腫患者におけるE7777の研究
The purpose of this study is to evaluate the objective response rate (ORR) of E7777 in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
化学療法未治療でステージIVの非扁平上皮非小細胞肺癌（NSCLC）患者を対象とした、アテゾリズマブとカルボプラチンまたはシスプラチン＋ペメトレキセドの併用療法と、カルボプラチンまたはシスプラチン＋ペメトレキセド単独療法との比較試験（IMpower 132）
This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase.
良性前立腺肥大症（BPH）に対するアルファ遮断薬を服用中の過活動膀胱（OAB）症状を有する男性被験者におけるミラベグロンの有効性、安全性、および忍容性を評価する第4相試験
The primary objective of the study was to investigate the efficacy of mirabegron versus placebo in male patients with OAB symptoms while taking the alpha blocker, tamsulosin, for BPH.
強皮症関連肺線維症患者を対象としたニンテダニブとプラセボの比較試験
Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.
再発・難治性B細胞急性リンパ性白血病の成人患者におけるUCART19の用量漸増試験
The study is in two parts: a dose escalation then a safety dose expansion. The purpose of the dose escalation part is to evaluate the safety and tolerability of ascending doses of UCART19 (dose-escalation part) given as a single infusion in patients with relapsed / refractory (R/R) B-cell acute lymphoblastic leukaemia (B-ALL), to determine the maximum tolerated dose (MTD), the recommended dose and the lymphodepletion regimen. The purpose of the safety dose expansion is to assess the safety and tolerability of the RD for UCART19.
MedJ-01 リダフォロリムス溶出冠動脈ステントシステム試験（JNIR）
MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: * A mounted Cobalt Chromium (CoCr) alloy based stent * A Rapid Exchange (RX) Coronary System Delivery System * A Poly n-butyl methacrylate (PBMA) and CarboSil®Polymer matrix coating * Ridaforolimus drug - CAS Registry Number: 572924-54-0 MedJ-01 is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to lesions in vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions. JNIR01 is aimed at assessing TLF at one year with the MedJ-01 stent in a Japanese patient population to show equivalence to the results of the BIONICS Trial.
脊柱変形手術における神経学的合併症 - 補足
272 subjects with "high risk" adult spinal deformity requiring surgical correction were enrolled in the previous prospective multi-center international Scoli-RISK-1 study. "High risk" patients were defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurological complications in the form of new motor and sensory deficits were monitored prospectively in all patients at hospital discharge, at 6 weeks (± 2 weeks), 6 months (± 2 months) and 24 months (± 2 months) after the surgery. The relationship to the surgical intervention was assessed in all new deficits. Regression analyses were used to evaluate the association between patient demographics, co-morbidities, treatment history, spinal deformity characteristics, surgical characteristics, non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit after surgery. All enrolled Scoli-RISK-1 participants will be re-consented and asked to return for a 5 year FU visit.
潰瘍性大腸炎の小児患者におけるアダリムマブの長期安全性および有効性試験
This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.
LCZ696の安全性、忍容性、薬物動態および薬力学を評価する試験に続き、心不全の小児患者を対象としたLCZ696とエナラプリルを比較する52週間の二重盲検試験を実施する。
This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.
オメカティブ・メカルビル（AMG 423）を用いた駆出率低下型慢性心不全治療に関する承認申請試験
The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).
悪性脳腫瘍である膠芽腫（GBM）の新規診断患者を対象とした、テモゾロミドとニボルマブまたはプラセボを併用した放射線療法による免疫療法の治験
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.
既治療急性骨髄性白血病患者を対象としたグアデシタビンと治療選択を比較する第3相無作為化非盲検試験
Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone: * High intensity (intermediate or high dose cytarabine \[HiDAC\]; mitoxantrone, etoposide, and cytarabine \[MEC\]; or fludarabine, cytarabine, granulocyte colony stimulating factor \[G-CSF\], +/- idarubicin \[FLAG/FLAG-Ida\]). * Low intensity (low dose cytarabine \[LDAC\], decitabine, or azacitidine). * BSC.
メトトレキサート療法にもかかわらず活動性関節リウマチを有する被験者におけるLBALとヒュミラ®の比較研究
This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.
日本人再発・難治性多発性骨髄腫患者を対象としたイサツキシマブ単剤療法試験
Primary Objectives: * Phase I: To evaluate safety and tolerability of isatuximab in Japanese participants with relapsed and refractory multiple myeloma. * Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese participants with relapsed and refractory multiple myeloma. Secondary Objectives: * To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events were assessed. * To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule. * To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria. * To assess the relationship between Baseline cluster of differentiation 38 (CD38) receptor density on multiple myeloma cells and efficacy.
化膿性汗腺炎の日本人被験者を対象としたアダリムマブの非盲検試験
This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe hidradenitis suppurativa (HS).
骨髄異形成症候群患者におけるボラセルチブ単独またはアザシチジン併用療法の臨床試験
The objectives of this trial are to evaluate the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics and preliminary efficacy of volasertib in two dosing schedules of intravenous volasertib as monotherapy or in combination with azacitidine in patients with myelodysplastic syndrome (MDS) after hypomethylating agents (HMA) treatment failure.
市中肺炎に対する無作為化埋め込み型多因子適応プラットフォーム試験
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.
GSKバイオロジカルズ社製帯状疱疹サブユニット（HZ/su）ワクチンの有効性、安全性、免疫原性の持続性を評価するための2つの試験110390（ZOSTER-006）と113077（ZOSTER-022）の長期追跡調査（ZOE-LTFU）と、高齢者の2つのサブグループにおける1回または2回の追加投与の評価
The purpose of this study was a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and included an assessment of 1 or 2 additional doses in two subgroups of older adults.