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中等度から重度のクローン病患者を対象とした、導入療法としてのオンタマリマブの有効性および安全性に関する研究(CARMEN CD 305)

中止NCT03559517第3相

The purpose of this study is to evaluate the efficacy and safety of ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

対象疾患:
Crohn's Disease

症候性特発性または糖尿病性胃不全麻痺の成人患者におけるTAK-906の有効性および安全性を評価する研究

完了NCT03544229第2相

The purpose of this study is to assess the efficacy and safety of treatment with 2 dose levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12 weeks of treatment.

対象疾患:
Diabetic GastroparesisIdiopathic Gastroparesis

ノルディトロピン®の長期使用に関する市販後調査(ヌーナン症候群による低身長)

完了NCT03435627

The purpose of this study is to collect information about safety and effectiveness for long term use of Norditropin®. Participants will attend the medical institution according to usual practice and receive medical care, as agreed with the study doctor.

対象疾患:
Genetic DisorderNoonan Syndrome

ボトックス®薬物使用調査(痙攣性発声障害)

不明NCT03543150

This study is a drug use investigation program of BOTOX. The objective of this investigation is to collect and assess information on the safety and efficacy of BOTOX injections in subjects with a diagnosis of spasmodic dysphonia in daily clinical practice. All subjects treated with BOTOX for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia will be included in this study. Approximately 400 subjects will be included in the study. The observation period per subject will be up to 12 months from the date of the first administration of BOTOX. The total study duration will be will be approximately 3 years from the date of approval for the indication of BOTOX for spasmodic dysphonia. BOTOX is a registered trademark of Allergan, Inc.

対象疾患:
Dysphonia

特定のKRAS変異を有する固形腫瘍患者におけるソトラシブ(AMG 510)の安全性、忍容性、薬物動態、および有効性を評価する第1/2相試験(CodeBreaK 100)

実施中(募集終了)NCT03600883第1/第2相

Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

対象疾患:
KRAS p.G12C Mutant Advanced Solid Tumors

小児患者におけるレバチオの長期使用に関する特別調査

完了NCT03364244

Secondary data collection study: safety and effectiveness of Revatio in pediatric patients under Japanese medical practice

対象疾患:
Pulmonary Arterial Hypertension

本研究は、様々な種類の癌(固形腫瘍)患者におけるBI 905677の安全な投与量を特定し、試験することを目的としている。

中止NCT03604445第1相

This study is open to adults with different types of advanced cancer (solid tumours). This study is open to people in whom previous treatments were not successful. The purpose of this study is to find out the highest dose of BI 905677 the participants can tolerate. BI 905677 is a type of an antibody that is being developed to treat cancer. One dose of BI 905677 is given to the participants every 2 or 3 weeks as infusion into a vein. In this study, BI 905677 is given to humans for the first time. The participants visit the study site at least once a week so that the doctors can check their general health. The participants are in the study for as long as they benefit from and can tolerate treatment.

対象疾患:
Neoplasms

頭蓋内動脈瘤の治療におけるMICRUSFRAMEコイルとGALAXYコイルの性能を検証する研究

完了NCT03642639該当なし

A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

対象疾患:
Aneurysms

手術可能なトリプルネガティブ乳がん患者における、アテゾリズマブ(抗PD-L1抗体)とアントラサイクリン/タキサン系補助化学療法の併用療法と化学療法単独療法を比較する研究

中止NCT03498716第3相

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

対象疾患:
Triple Negative Breast Cancer

Lynparza乳がん臨床経験調査

完了NCT03590938

To characterise the development of ADRs of bone marrow depression in patients under actual post-marketing use

対象疾患:
Breast Cancer

この研究では、BI 409306が統合失調症患者の症状悪化を予防するかどうかを検証します。この研究では、患者のBI 409306に対する忍容性と、6ヶ月間の投与期間における有効性について検証します。

中止NCT03351244第2相

The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of schizophrenia symptoms.

対象疾患:
Schizophrenia

ステンフィルコンAコンタクトレンズの臨床評価

完了NCT03471832該当なし

This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).

対象疾患:
Myopia

進行性核上性麻痺(PSP)におけるABBV-8E12の延長試験

中止NCT03391765第2相

The purpose of this study was to assess the long-term safety and efficacy of ABBV-8E12 (tilavonemab) in participants with progressive supranuclear palsy (PSP).

対象疾患:
Progressive Supranuclear Palsy (PSP)

プロテアソーム阻害剤ベースの注射療法で初期治療を受けた再発性および/または難治性多発性骨髄腫患者における、イキサゾミブとレナリドミドおよびデキサメタゾンの併用療法の有効性および安全性を評価する研究

完了NCT03416374第4相

The purpose of this study is to investigate the efficacy and safety of long-term administration of the oral proteasome inhibitor ixazomib as part of ixazomib in combination with lenalidomide and dexamethasone (IRd) therapy in patients with relapsed and/or refractory multiple myeloma (RRMM) treated initially with an injectable proteasome inhibitor-based therapy.

対象疾患:
Relapsed and/or Refractory Multiple Myeloma

ループス腎炎患者におけるBI 655064の探索的維持療法試験

完了NCT03385564第2相

The main objectives of this trial are to evaluate the long term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC) during maintenance therapy for lupus nephritis.

対象疾患:
Lupus Nephritis

同種造血幹細胞移植(Allo-HSCT)を受ける患者における腸管急性移植片対宿主病(aGVHD)の予防におけるベドリズマブの使用

完了NCT03657160第3相

The purpose of this study is to evaluate the efficacy of vedolizumab when added to background aGvHD prophylaxis regimen compared to placebo and background aGvHD prophylaxis regimen on intestinal aGvHD-free survival by Day +180 in participants who receive allo-HSCT as treatment for a hematologic malignancy or myeloproliferative disorder.

対象疾患:
Hematopoietic Stem Cells

急性リンパ性白血病の成人患者におけるポナチニブとイマチニブの比較試験

実施中(募集終了)NCT03589326第3相

In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib. The main aim of this study is to compare the number of participants on each treatment that show no signs of disease. Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study.

対象疾患:
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)

慢性腎臓病に伴う貧血を有するESA非服用透析患者を対象としたMT-6548の有効性および安全性評価試験(日本)

完了NCT03461146第3相

For hemodialysis subjects not receiving ESAs with anemia associated with chronic kidney disease, evaluate Hb correction and maintenance effect and safety of MT-6548.

対象疾患:
Anemia; Hemodialysis Dependent Chronic Kidney Disease

うつ病を患う日本人小児および青年に対するデュロキセチン(LY248686)の治療効果に関する研究

中止NCT03395353第3相

The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder.

対象疾患:
Depressive Disorder

重症下肢虚血患者におけるDES BTK血管ステントシステムとPTAの比較

完了NCT03551496第3相

Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).

対象疾患:
Critical Limb Ischemia