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潰瘍性大腸炎(UC)の小児および青年を対象としたミリキズマブ(LY3074828)の研究

完了NCT04004611第2相

This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab. The study lasted about 52 weeks and included up to 18 visits.

対象疾患:
Ulcerative Colitis

血管造影iFRのための放射線画像検証および評価(ReVEAL iFR)

完了NCT03857503

The Philips Angio-iFR medical software device is intended to provide information on the functional significance of a coronary artery lesion to provide guidance on diagnostic decisions similar to that obtained through invasive measures of iFR and FFR. The software application uses the vessel geometry obtained from a coronary angiographic image together with a lumped parameter physiological model to provide the associated iFR and FFR estimates.

対象疾患:
Cardiac IschemiaCoronary Artery DiseaseCoronary Stenosis

カルメット・ゲラン菌(BCG)投与後に再発した高リスク非筋層浸潤性膀胱癌(NMIBC)患者におけるエルダフィチニブと治験担当医の選択による膀胱内化学療法の比較研究

完了NCT04172675第2相

The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor fibroblast growth factor receptor (FGFR) mutations or fusions, and who recurred after bacillus calmette-guerin (BCG) therapy.

対象疾患:
Urinary Bladder Neoplasms

慢性片頭痛の小児患者におけるエレヌマブの有効性と安全性

完了NCT03832998第3相

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to \<12 years) and adolescents (12 to \<18 years) with chronic migraine. The study hypothesis is that in pediatric participants with chronic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).

対象疾患:
Migraine

AG-348-006またはAG348-C-007に以前登録されたピルビン酸キナーゼ欠損症の成人参加者におけるAG-348の延長試験

完了NCT03853798第3相

This is an open-label, multicenter, extension study to evaluate the long-term safety, tolerability, and efficacy of treatment with mitapivat in participants who were previously enrolled in Study AG348-C-006 or Study AG348-C-007.

対象疾患:
Pyruvate Kinase Deficiency

KW-6356とクラリスロマイシンまたはリファンピシンの薬物相互作用に関する研究

完了NCT04070495第1相

The purpose of this study is to investigate the effects of CYP3A4/5 inhibitor or inducer on the pharmacokinetics of KW-6356 when CYP3A4/5 inhibitor or inducer is orally administered to healthy Japanese men for 7 days.

対象疾患:
Parkinson's Disease

進行性または転移性HER2陽性乳がん患者を対象とした、ツカチニブとアドトラスツズマブ・エムタンシン(T-DM1)の併用療法におけるプラセボとの比較試験

実施中(募集終了)NCT03975647第3相

This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

対象疾患:
HER2-positive Breast Cancer

円形脱毛症治療におけるPF-06651600の長期投与

実施中(募集終了)NCT04006457第3相

This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug. A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.

対象疾患:
Alopecia Areata

日本における高リスク転移性ホルモン療法未治療前立腺癌患者の臨床転帰を観察するためのレジストリ研究

完了NCT04034095

The purpose of this registry study is to longitudinally observe clinical outcomes and patient-reported outcomes (PRO) for participants with high-risk metastatic hormone-naive prostate cancer (mHNPC) in the real-world setting in Japan.

対象疾患:
Prostatic Neoplasms

進行性または転移性乳がんまたは子宮内膜がん患者を対象としたLY3484356の研究

実施中(募集終了)NCT04188548第1相

The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.

対象疾患:
Advanced Breast CancerBreast CancerEndometrial CancerMetastatic Breast Cancer

中等度から重度の尋常性乾癬に対するPF-06826647の安全性と有効性を評価する研究

完了NCT03895372第2相

This multicenter study is being conducted to provide additional PF-06826647 safety and tolerability data, and to further explore the clinical efficacy of PF-06826647 in the treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to enable selection of oral dose and dosing regimen for the future clinical development of PF-06826647.

対象疾患:
Psoriasis

進行固形腫瘍患者におけるDKY709単独またはPDR001との併用の安全性および有効性の研究。

実施中(募集終了)NCT03891953第1相

This is a phase I/Ib, open label study. The escalation portion will characterize the safety and tolerability of DKY709 and DKY709 in combination with PDR001 in subjects with NSCLC or melanoma who have received prior anti-PD-1/PD-L1 therapy, or subjects with NPC. After the determination of the MTD/RD for a particular treatment arm, dose expansion will further assess safety, tolerability, PK/PD, and anti-tumor activity of each regimen at the MTD/RD.

対象疾患:
Carcinoma, Non-Small-Cell LungMelanomaMicrosatellite Stable Colorectal CancerNasopharyngeal CarcinomaTriple Negative Breast Cancer

アジア太平洋地域における心房細動のHDマッピング

完了NCT04022954

The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the real-world environment of the Asian population.

対象疾患:
Paroxysmal Atrial FibrillationPersistent Atrial Fibrillation

重症血友病A患者を対象とした、静脈内投与の組換え凝固第VIII因子Fc-フォン・ヴィレブランド因子-XTEN融合タンパク質、エファネソクトコグアルファ(BIVV001)の第3相オープンラベル介入試験

完了NCT04161495第3相

Primary Objective: \- To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm. Secondary Objectives: * To evaluate the efficacy of BIVV001 as a prophylaxis treatment. * To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. * To evaluate BIVV001 consumption for the prevention and treatment of bleeding episodes. * To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. * To evaluate the effect of BIVV001 prophylaxis on Quality of Life outcomes. * To evaluate the efficacy of BIVV001 for perioperative management. * To evaluate the safety and tolerability of BIVV001 treatment. * To assess the pharmacokinetics (PK) of BIVV001 based on the 1-stage activated partial thromboplastin time (aPTT) and 2-stage chromogenic coagulation factor VIII (FVIII) activity assays.

対象疾患:
Factor VIII Deficiency

進行性線維性間質性肺疾患(PF-ILD)患者におけるニンテダニブの長期治療に関する追跡調査

完了NCT03820726第3相

The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).

対象疾患:
Lung Diseases, Interstitial

TS-142の健康な被験者を対象とした第I相試験(反復投与)

完了NCT04169906第1相

The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly participants.

対象疾患:
Healthy Volunteer

1つ以上の標準治療に十分な反応を示さなかった活動性多発性筋炎および皮膚筋炎の患者を対象としたウステキヌマブの研究

中止NCT03981744第3相

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active polymyositis (PM)/dermatomyositis (DM) despite receiving 1 or more standard-of-care treatments (for example, glucocorticoids and/or immunomodulators).

対象疾患:
DermatomyositisPolymyositis

異染性白質ジストロフィーの小児における脊髄内SHP611の研究

実施中(募集終了)NCT03771898第2相

The main aim of the study is to determine if SHP611 given by injection into the spinal fluid that surrounds the brain and spinal cord (intrathecal; IT) prolongs the time for children with Metachromatic Leukodystrophy (MLD) to retain the ability to move from place to place. Other aims of the study are to determine the effects of intrathecal administration of SHP611 on movement and speech functions and to learn how well SHP611 injected in the spinal fluid that surrounds the brain and spinal cord is tolerated. Study participants will receive SHP611 for about 2 years with the possibility of an extended treatment period.

対象疾患:
Metachromatic Leukodystrophy (MLD)

進行固形腫瘍患者におけるAMG 404

完了NCT03853109第1相

To evaluate the safety and tolerability of AMG 404, a monoclonal antibody that binds to PD-1 and inhibits its engagement with ligands, in patients with advanced solid tumors.

対象疾患:
Advanced Solid Tumors

潰瘍性大腸炎におけるGSK2831781の安全性、忍容性、有効性および用量反応

中止NCT03893565第2相

This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 30-week double-blind Extended Treatment Phase (ETP) with 42-week Follow-Up Phase. Non-Responders identified following the Week 10 assessment will be allocated to open label treatment, consisting of Induction (Weeks 12 to 22), an Open label ETP (Weeks 22 to 42) and a follow-Up to Week 54.

対象疾患:
Colitis, Ulcerative