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ジェネンテックおよび/またはF.ホフマン・ラ・ロシュがスポンサーとなった研究に以前参加した参加者のためのロールオーバー研究

募集中NCT05862285第3相

The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP\[s\]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.

対象疾患:

プロピオン酸血症患者の特徴を明らかにするための回顧的研究

募集中NCT05769621

This is a non-interventional, observational, global, multicenter, study describing participant characteristics, clinical outcomes, and event rates in participants with propionic acidemia (PA).

対象疾患:
プロピオン酸血症

血友病に伴うHIV/HCV重複感染による肝硬変患者を対象としたフォスセンビビンの第2相試験(OP-724-H201)

実施中(募集終了)NCT06144086第2相

This is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia to evaluate the efficacy, safety and pharmacokinetics.

対象疾患:
Liver Cirrhosis

高齢者の知的機能と筋肉量に対する栄養、睡眠、身体活動の影響

不明NCT06135740該当なし

The goal of this prospective, single site, interventional randomized control trial is to treat age related health conditions in adults older than 65 years and functional independence. The main question of the study is to answer the effectiveness of notification on activity, sleep, and nutrition based on wearable device Fitbit recorded data for the improvement of health conditions including intellectual property and physical function, compared to usual care. Participants in the intervention arm will be given a Fitbit Charge 5 device and asked to wear this for the duration of the study, including during sleep. The study intervention will run for 6 months. Notifications will be issued using a monitoring software in Japanese, and issued automatically to participants. Participants in the control arm will be given a routine care and health-related information. Researchers will compare cognitive performance, muscle mass and physical activity between the two groups to see if the notification based on Fitbit data would promote the health conditions of older adults.

対象疾患:
Cognition Disorders in Old AgeCognitive FunctionFrailty/SarcopeniaMCI

ブライトライン4:脱分化型脂肪肉腫と呼ばれる癌患者におけるブリギマドリンの忍容性を検証する研究

完了NCT06058793第3相

This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumours are positive for MDM2. The purpose of this study is to find out whether a medicine called brigimadlin (BI 907828) is tolerated by and helps people with DDLPS. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Participants take brigimadlin as a tablet once every 3 weeks. Participants may continue to take brigimadlin as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check participants' health and take note of any unwanted effects. The doctors also regularly check tumour size.

対象疾患:
Liposarcoma, Dedifferentiated

アギオスがスポンサーとなったミタピヴァット研究を完了した参加者にミタピヴァットへの継続的なアクセスを提供するための研究

招待制NCT05777993第4相

The purpose of this study is to provide continued access to mitapivat for participants who completed an Agios-sponsored mitapivat study (antecedent) and do not have commercial access to mitapivat.

対象疾患:
Anemia, HemolyticPyruvate Kinase Deficiency

トリプルネガティブ乳がんまたはホルモン受容体低発現/HER2陰性乳がんの術前/術後補助療法におけるDato-DXdとデュルバルマブを評価する第III相ランダム化試験

実施中(募集終了)NCT06112379第3相

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

対象疾患:
Breast Cancer

進行性または転移性固形腫瘍患者におけるINCA33890の安全性を評価する研究

募集中NCT05836324第1相

To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.

対象疾患:
Advanced Solid TumorsMetastatic Solid TumorsSolid Tumors

再発性/難治性(R/R)急性骨髄性白血病(AML)の成人患者を対象とした、静脈内(IV)投与されたABBV-787の有害事象および動態を評価する試験

中止NCT06068868第1相

Acute myeloid leukemia (AML) is the second most common type of leukemia diagnosed in adults and children, but most cases occur in adults. This study is to evaluate how safe ABBV-787 is and how it moves within the body in adult participants with relapsed/refractory (R/R) acute myeloid leukemia (AML). Adverse events and maximum tolerated dose (MTD) of ABBV-787 will be assessed. ABBV-787 is an investigational drug being developed for the treatment of AML. Participants will receive ABBV-787 in escalating doses until the maximum tolerated dose (MTD) is determined. Approximately 60 adult participants with a diagnosis of AML will be enrolled worldwide. Participants will receive intravenous (IV) infusions of ABBV-787 during the approximately 3 year duration a participant is followed. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.

対象疾患:
Acute Myeloid Leukemia

東アジアの過剰体重の人々の減量にCagriSemaがどの程度効果があるかを調べる研究

完了NCT05813925第3相

This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1½ years.

対象疾患:
Obesity or Overweight

重症喘息の成人患者を対象としたVerekitug(UPB-101)の有効性と安全性を調査する試験(VALIANT試験)

実施中(募集終了)NCT06196879第2相

The purpose of this study is to evaluate the efficacy and safety of verekitug (UPB-101) in participants with severe asthma. The study will evaluate the incidence of asthma exacerbations, other pharmacodynamic (PD) parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo.

対象疾患:
重度の喘息

中等度から重度のアトピー性皮膚炎(AD)の成人および青年患者を対象としたロカチンリマブの長期安全性、忍容性および有効性を評価する研究

実施中(募集終了)NCT05882877第3相

The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.

対象疾患:
Atopic Dermatitis

脳や脊髄に関連する問題を除く、身体に既知または疑われる問題のある人を対象に、ガドクアトランの効果と安全性を既存のMRI造影剤と比較する研究

完了NCT05915728第3相

Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI). MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation. The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI. The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent. The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein. Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits. At the start or during the study, the doctors and their study team will: * take blood and urine samples * do physical examinations * check blood pressure and heart rate * review the MRI scans obtained in the study and decide on the diagnosis * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

対象疾患:
Contrast Enhancement in Magnetic Resonance ImagingNon-central Nervous System Pathology

高リスク悪性黒色腫患者を対象としたインティスメラン・オートジェン(V940)とペムブロリズマブの併用療法に関する臨床試験(V940-001)

実施中(募集終了)NCT05933577第3相

The purpose of this study is to learn if intismeran autogene which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid \[mRNA\]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if intismeran autogene with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.

対象疾患:
Melanoma

KRAS G12C変異を有するNSCLCにおける2つのアダグラシブ投与レジメンの試験(KRYSTAL 21)

募集中NCT05853575第2相

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.

対象疾患:
進行癌肺の悪性腫瘍転移性癌

IC-MPGN患者におけるイプタコパンの有効性と安全性に関する研究

募集中NCT05755386第3相

This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.

対象疾患:
IC-MPGN

ステージIVまたは進行期ステージIIIB/Cの非扁平上皮非小細胞肺がん患者を対象とした、ソトラシブプラチナ製剤2剤併用とペムブロリズマブプラチナ製剤2剤併用を第一選択療法として評価する試験(CodeBreaK 202)

募集中NCT05920356第3相

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

対象疾患:
非小細胞肺がん(NSCLC)

マイクロサテライト不安定性またはミスマッチ修復欠損と呼ばれる特定の DNA 変異を持つ癌患者における HRO761 単独または併用療法の研究。

募集中NCT05838768第1相

The main purpose of the study is to evaluate the safety and tolerability of HRO761 and identify the recommended dose(s), i.e., the optimal safe and active dose of HRO761 alone or in combination with pembrolizumab or irinotecan that can be given to patients who have cancers with specific molecular alterations called MSIhi (Microsatellite Instability-high) or dMMR (Mismatch Repair Deficient) that might work best to treat these specific cancer types and to understand how well HRO761 is able to treat those cancers.

対象疾患:
MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers

進行性または転移性固形腫瘍の成人患者を対象としたAZD5863の試験

募集中NCT06005493第1/第2相

This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.

対象疾患:
Esophageal AdenocarcinomaGastric CancerGastro-esophageal Junction CancerPancreatic Ductal Adenocarcinoma

研究薬への継続的なアクセスを提供し、長期安全性を評価するための研究

募集中NCT06174987第3相

This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).

対象疾患:
Advanced CancerMetastatic Cancer