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トランスサイレチンアミロイドーシスによる心不全患者に対するNNC6019-0001と呼ばれる薬剤の長期治療を検討する研究

実施中(募集終了)NCT06260709第2相

This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years).

対象疾患:
Transthyretin Amyloid Cardiomyopathy (ATTR CM)

VEXAS症候群患者におけるパクリチニブの有効性と安全性を評価する研究(PAXIS)

実施中(募集終了)NCT06782373第2相

This trial is to assess the effectiveness and safety of pacritinib in patients with VEXAS (i.e., Vacuoles in myeloid progenitors, E1 ubiquitin-activating enzyme, X-linked, autoinflammatory manifestations, and somatic) syndrome. 78 participants will be enrolled, randomized to either pacritinib dose A, pacritinib dose B + placebo, or placebo. Randomization will be stratified by prescribed GC dose on the day of randomization.

対象疾患:
VEXASVEXAS Syndrome

LCZ696単剤療法でコントロール不良なグレード1および2の高血圧患者におけるLCZ696/アムロジピンの有効性と安全性の試験

完了NCT06236061第3相

This CLAZ696B11302 study is composed of two parts; the Core part including double-blind period, and the open-label extension (OLE) part which is an open-label extension of the Core part. The purpose of the Core part is to demonstrate that LCZ696 (LCZ) when used in combination with amlodipine (AML), denoted as LCZ/AML, will provide greater blood pressure lowering benefit compared to LCZ monotherapy in patients with grade 1 and 2 hypertension not adequately controlled with LCZ monotherapy. The purpose of the OLE part is to assess the long-term safety, tolerability and efficacy of the treatment with LCZ/AML.

対象疾患:
Hypertension

PD-L1陽性転移性非小細胞肺癌患者の第一選択治療におけるイボネスシマブの臨床試験

募集中NCT06767514第3相

Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.

対象疾患:
Non-Small Cell Lung Cancer

膝関節炎患者を対象としたCLS2901Cの第III相試験

募集中NCT06549686第3相

To evaluate the efficacy and safety of CLS2901C human allogenic chondrocyte sheets used in the osteotomy + RMSC group compared to in the osteotomy alone group of patients with osteoarthritis of the knee (OAK).

対象疾患:
Osteoarthritis of the Knee

プラチナ製剤抵抗性卵巣がん患者におけるRina-Sと治験担当医師の選択治療の有効性を比較する研究

募集中NCT06619236第3相

This phase 3 study will be conducted in different countries all over the world. The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer. Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose. All participants will receive active drug; no one will be given placebo.

対象疾患:
プラチナ耐性卵巣がん

中等度から重度のシェーグレン病におけるニポカリマブ

募集中NCT06741969第3相

The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).

対象疾患:
シェーグレン症候群

進行期小細胞肺癌患者におけるタルラタマブ皮下投与(DeLLphi-308)

募集中NCT06598306第1相

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

対象疾患:
Extensive Stage Small Cell Lung Cancer

ウイルス学的に抑制されたHIV-1感染者における経口週1回イスラトラビル/レナカパビル療法と標準治療との比較研究

実施中(募集終了)NCT06630299第3相

The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs). The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48.

対象疾患:
HIV-1-Infection

中等度から重度の活動性甲状腺眼症の成人男女を対象に、テプロツムマブ皮下投与とプラセボを比較する試験

実施中(募集終了)NCT06248619第3相

The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.

対象疾患:
Thyroid Eye Disease

BI 1815368の様々な投与量に対する耐性および健康な日本人男性の体内へのBI 1815368の取り込みを検証する研究

完了NCT06494774第1相

The main objectives of this trial are to investigate safety, tolerability. pharmacokinetics (PK), and pharmacodynamics of BI 1815368 in healthy Japanese male subjects following administration of single rising doses or multiple doses.

対象疾患:
Healthy

HAEの青年および成人における血管性浮腫発作の予防のための経口デュクリチバント徐放錠の研究

実施中(募集終了)NCT06669754第3相

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to prevent angioedema attacks in participants aged ≥ 12 years with hereditary angioedema.

対象疾患:
遺伝性血管性浮腫(HAE)

クローン病におけるAZD7798を評価する第IIa相試験

実施中(募集終了)NCT06450197第2相

This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 in participants with moderate to severe Crohn's disease.

対象疾患:
中等度から重度のクローン病

原発性肝癌の鑑別診断のためのエクソソームを用いた液体生検

募集中NCT06342414

It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery.

対象疾患:
CholangiocarcinomaHepatic CancerHepatic CarcinomaHepatocellular CarcinomaIntrahepatic Cholangiocarcinoma2

アルツハイマー病に伴う精神病の治療薬としてのKarXTを評価する研究(ADEPT-4)

募集中NCT06585787第3相

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

対象疾患:
アルツハイマー病

低軟骨形成症の小児に対するボソリタイドの介入研究

実施中(募集終了)NCT06455059第3相

The intent and design of this Phase 3 study is to assess vosoritide as a therapeutic option for the treatment of children with hypochondroplasia (HCH).

対象疾患:
Hypochondroplasia

健康なボランティアとパーキンソン病患者を対象としたLY3962681の臨床試験

募集中NCT06565195第1相

The purpose of this study is to evaluate the safety, tolerability, and PK/PD of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study will be comprised of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Doses (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid (aCSF), no active drug) given into the spinal fluid. During the MAD portion of the study, patients with Parkinson's disease will receive two doses of either LY3962681 or placebo (aCSF) administered into the spinal fluid. * The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 days, 12 to 24 weeks apart. * The follow-up period in the SAD study will be up to 52 weeks. The follow-up period in the MAD study will be up to 52 weeks post Dose 2.

対象疾患:
Parkinson's Disease

うつ病患者におけるBI 1569912の異なる用量を試験する研究

完了NCT06558344第2相

This study is open to adults between 18 and 65 years of age with a type of depression called major depressive disorder. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression. Participants are put into 4 groups randomly, which means by chance. Three of the 4 groups take different doses of BI 1569912 and 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks. Participants are in the study for about 2.5 months. During this time, they visit the study site at least 7 times. At the visits, doctors and their staff ask participants about their depression symptoms. At the end of the study, the results are compared between the groups to see whether the treatment works. The doctors also regularly check the general health of participants and take note of any unwanted effects.

対象疾患:
Depressive Disorder, Major

転移性膵管腺癌患者におけるクエムリクルスタットと化学療法の併用とプラセボと化学療法の併用を比較する試験

実施中(募集終了)NCT06608927第3相

The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.

対象疾患:
Metastatic Pancreatic Ductal Adenocarcinoma

慢性期脳卒中患者に対する脳内自家幹細胞療法

募集中NCT06752720第2相

The goal of this clinical trial is to evaluate if autologous mesenchymal stem cell (HUNS001-01) transplantation therapy can provide neurological recovery in patients with chronic stage of stroke resulting in moderate to severe neurological sequelae. The main questions it aims to answer are: Can HUNS001-01 intracerebral transplantation demonstrate improvement in the mRS of disability for 1 year after intervention? Can HUNS001-01 intracerebral transplantation can be performed without any adverse events for 1 year after intervention? Participants will receive the below interventions. * Screening for the eligibility to enroll the clinical trial (interview, blood test, imaging) * Harvest of platelet concentrates (PC) * Harvest of bone marrows (BM) * Receive intracerebral transplantation surgery of HUNS001-01 * Post-operative rehabilitation * Follow-up studies (until 1 year or termination of the trial)

対象疾患:
StrokeStroke, IschemicStroke; Sequelae