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巣状分節性糸球体硬化症(FSGS)の成人患者におけるPF-06730512の評価に関する研究

中止NCT03448692第2相

The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS.

対象疾患:
Focal Segmental Glomerulosclerosis (FSGS)

小児患者におけるアトピー性皮膚炎の観察評価

実施中(募集終了)NCT03687359

Primary Objectives: * To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable. * To evaluate the time-course of AD and selected atopic comorbidities. Secondary Objectives: * To characterize disease burden and unmet need. * To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching). * To document the real-world effectiveness and safety of treatments.

対象疾患:
Dermatitis Atopic

BRAF V600陽性ステージIIIメラノーマの完全切除後の補助療法におけるダブラフェニブ+トラメチニブの併用療法による発熱関連転帰への影響の評価

完了NCT03551626第3相

The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.

対象疾患:
Malignant Melanoma

日本人腎細胞癌患者におけるPD-L1の発現

完了NCT03748901

This is a multicenter retrospective study designed to compare overall survival (OS) by PD-L1 expression status in patients with RCC who have received systemic chemotherapy for recurrent or metastatic RCC, to determine whether the prognosis is worse in PD-L1-positive than in PD-L1-negative RCC. Total 600 RCC surgical specimens will be collected from patients who started systemic chemotherapy for recurrent or metastatic RCC between January 1, 2010 and December 31, 2015 at about 30 participating study sites in Japan. PD-L1 expression status (IC; immune cell) on tumor-infiltrating immune cells will be evaluated by IHC, and classified by score: IC0 (PD-L1-negative) and IC1, IC2, IC3 (PD-L1-positive). Unless otherwise specified, between-group comparisons will be performed between IC0 and IC1/2/3.

対象疾患:
Renal Cell Carcinoma

中等度から重度の成人アトピー性皮膚炎患者を対象とした、バリシチニブ(LY3009104)と局所コルチコステロイドの併用療法に関する研究

完了NCT03733301第3相

The purpose of this study is to evaluate the efficacy and safety of baricitinib in combination with topical corticosteroids (TCS) in participants with moderate to severe atopic dermatitis.

対象疾患:
Atopic Dermatitis

切除不能、局所進行性または転移性非小細胞肺癌患者におけるアテゾリズマブの有効性に関する研究(J-TAIL)

完了NCT03645330

This prospective, observational study is to assess the long-term effectiveness and safety of Atezolizumab in patients with advanced non-small cell lung cancer in clinical practice.

対象疾患:
Non-small-Cell Lung Cancer

中等度から重度の尋常性乾癬患者におけるミリキズマブとセクキヌマブおよびプラセボとの比較による有効性と安全性を評価する研究(OASIS-2)

完了NCT03535194第3相

The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.

対象疾患:
Psoriasis

アルツハイマー型認知症に伴う興奮状態の治療におけるブレクスピプラゾール

完了NCT03620981第2/第3相

To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the safety of brexpiprazole and identify the optimum dose.

対象疾患:
Agitation Associated With Dementia of the Alzheimer's Type

NPC-15(NPC-15-7)の不整脈誘発作用の調査

完了NCT03475459第1相

A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)

対象疾患:
Qt Interval, Variation in

HER2陽性早期乳がん患者を対象とした、ペルツズマブとトラスツズマブの固定用量配合剤の皮下投与と化学療法の併用における薬物動態、有効性、および安全性を評価する研究

完了NCT03493854第3相

This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.

対象疾患:
Early Breast Cancer

切除不能または転移性胆管癌におけるペミガチニブと化学療法の有効性と安全性を評価する研究

中止NCT03656536第3相

The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

対象疾患:
Metastatic CholangiocarcinomaUnresectable Cholangiocarcinoma

未治療のステージIVまたは再発非小細胞肺癌患者を対象とした、実験薬BMS-986205とニボルマブを併用投与した場合と化学療法を併用投与した場合との比較による免疫療法研究

取り下げNCT03417037第3相

This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.

対象疾患:
Lung CancerNon-Small Cell Lung Cancer

多枝病変患者における血管造影に基づく冠血流予備量比

完了NCT03455244

This is a prospective, observational, single-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis in Multi-Vessel Disease.

対象疾患:
Multi Vessel Coronary Artery Disease

固形腫瘍患者を対象としたE7130の研究

完了NCT03444701第1相

The primary objective of this study is to evaluate the tolerability and safety profile of E7130 in participants with solid tumors.

対象疾患:
Solid Tumors

進行性食道扁平上皮癌患者を対象とした、二次治療としてのティスレリズマブ(BGB-A317)と化学療法との比較研究

完了NCT03430843第3相

The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.

対象疾患:
Esophageal Squamous Cell Carcinoma (ESCC)

ウィルソン病患者を対象としたALXN1840の48週間投与と標準治療との比較における有効性および安全性

中止NCT03403205第3相

The study will evaluate the efficacy and safety of ALXN1840 (formerly called WTX101) administered for 48 weeks compared to standard of care (SoC) in Wilson Disease (WD) participants aged 12 and older in the Primary Evaluation Period. In addition, efficacy and safety will be evaluated during an optional 60-month Extension Period.

対象疾患:
Wilson Disease

出血性脳卒中に対する組換え因子VIIa(rFVIIa)の臨床試験

実施中(募集終了)NCT03496883第3相

The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.

対象疾患:
Intracerebral Hemorrhage

過体重または肥満の2型糖尿病患者におけるセマグルチドの効果を調査する研究

完了NCT03552757第3相

This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years

対象疾患:
ObesityOverweight

中等度から重度のクローン病患者を対象とした、オンタマリマブの維持療法としての有効性および安全性に関する研究(CARMEN CD 307)

中止NCT03627091第3相

The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).

対象疾患:
Crohn's Disease

軟骨無形成症の乳幼児におけるBMN 111の安全性と有効性を評価する臨床試験

完了NCT03583697第2相

Study 111-206 is a Phase 2 randomized, double-blind, placebo-controlled clinical trial of BMN 111 in infants and young children with a diagnosis of achondroplasia.

対象疾患:
Achondroplasia