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転移性去勢抵抗性前立腺がんの成人患者における有害事象および静脈内(IV)投与されたABBV-969の体内での移動を評価する研究

募集中NCT06318273第1相

Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy. ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 140 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years. 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 and may require frequent medical assessments, blood tests, and scans.

対象疾患:
Metastatic Castration-Resistant Prostate Cancer

再発性/難治性(R/R)B細胞NHL患者における単剤療法としてのスロバタミグ(AZD0486)

募集中NCT06526793第2相

This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of Surovatamig (AZD0486) monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for LBCL.

対象疾患:
B-cell Non-Hodgkin LymphomaFollicular Lymphoma (FL)Large B-Cell Lymphoma (LBCL)

プラチナ製剤併用化学療法を受けた非小細胞肺癌の完全切除患者を対象とした、チラゴルマブとアテゾリズマブの併用とプラセボとアテゾリズマブの併用を比較する試験

完了NCT06267001第3相

この研究の目的は、切除および補助化学療法後の非小細胞肺癌(NSCLC)患者に投与されたチラゴルマブとアテゾリズマブの併用療法の有効性と安全性を、プラセボとアテゾリズマブの併用療法と比較して評価することです。

対象疾患:
非小細胞肺がん(NSCLC)

長期使用に関する特別薬剤使用結果調査(アバコパン)

募集中NCT06758271

The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.

対象疾患:
Granulomatosis With Polyangiitis (GPA)Microscopic Polyangiitis (MPA)

SMARCA4変異を有する進行性または転移性固形腫瘍患者を対象とした経口SMARCA2分解剤PRT7732の研究

中止NCT06560645第1相

これは、SMARCA4 変異を伴う特定の進行性または転移性固形腫瘍の患者における PRT7732 の安全性、忍容性、薬物動態、薬力学、および予備的な有効性を判断する第 1 相試験です。

対象疾患:
進行固形腫瘍食道腺癌食道扁平上皮癌胃腺癌胃扁平上皮癌5

ONO-2017 試験:原発性全般強直間代発作のある日本人患者

募集中NCT06579573第3相

To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.

対象疾患:
Epilepsy, Generalized

日本の成人敗血症患者における播種性血管内凝固症候群(DIC)の発症に関する観察研究

完了NCT06373159

This is an observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied. In observational studies, only observations are made without participants receiving any advice or changes to their healthcare. DIC is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. People who have sepsis or cancer are at a higher risk of developing DIC. To find a treatment that works well for people with DIC associated with sepsis, it is important to know about its occurrence, treatments people receive, and their outcomes. Japan is the only country that has officially approved medicines for DIC including a few newer medicines that prevent extensive blood clotting. In this study, researchers will assess patient data from a hospital database in Japan. The main purpose of this study is to learn more about how many adults develop DIC related to sepsis, thrombocytopenic sepsis (sudden decrease in the number of platelets in the blood), or septic shock (dangerously low blood pressure) in Japan every year. To learn about this, researchers will collect the following information: * The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis * The grading scores given to the participants which are used to assess the likelihood, cause, severity, treatment plan, and outcome of DIC (including scores called JAAM, ISTH, MHLW, and/or SOFA scores) * The number of days between diagnosis of sepsis and the beginning of DIC Researchers will study the data collected between June 2018 and June 2023. The data will come from TXP Medical, which collects data through the hospital health information system of 7 selected hospitals for this study across Japan. In this study, only available data from routine care are collected.

対象疾患:
Disseminated Intravascular CoagulationSepsis

肺動脈性高血圧症(PAH)患者を対象としたソタテルセプト(MK-7962)の臨床試験(MK-7962-024)

完了NCT06664801第2相

Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs. The goal of the study is to learn: * What happens to different doses of sotatercept in a person's body over time when it is given using weight-banded doses compared to weight-based doses. There may be differences in how the medicine works with the new dosing method (weight-banded dosing) being studied in this trial. * About the safety of sotatercept and if people tolerate it

対象疾患:
Pulmonary Arterial Hypertension

18歳以上の男女を対象に、デュピルマブ注射とプラセボを比較した慢性単純性苔癬の掻痒改善効果を調査する研究(STYLE 1)

実施中(募集終了)NCT06687967第3相

This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged at least 18 years with LSC. Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The follow-up duration after treatment will be 12 weeks. The number of visits will be 6.

対象疾患:
Lichen Simplex Chronicus

転移性膵臓腺癌の治療歴のない日本人被験者を対象とした、イリノテカンリポソーム注射剤、オキサリプラチン、5-フルオロウラシル/レボロイコボリンの第2相試験

実施中(募集終了)NCT06225999第2相

This study is to assess the anti-tumour activity, safety and tolerability of irinotecan liposome injection (S095013) in combination with oxaliplatin, 5-Fluorouracil (5-FU) and levoisomer form of leucovorin (LLV). S095013, oxaliplatin, 5-FU and LLV will be administered on days 1 and 15 of each 28-day cycle. Cycles will continue until clinical or radiological progressive disease, unacceptable study medication-related toxicity or withdrawal from study. During the treatment period participants will have study visits on day 1, 3, 15, and 17 of each cycle, some of which may occur as a home visit. At least 30 days after treatment has ended a end of treatment visit will occur and then participants will be followed for survival every month via telephone or email until death or end of the study. Study visits may include questionnaires, blood and urine tests, ECG, vital signs, physical examination, and administration of study treatment.

対象疾患:
Metastatic Adenocarcinoma of the Pancreas

転移性扁平上皮非小細胞肺癌(NSCLC)の一次治療におけるリルベゴストミグまたはペムブロリズマブと化学療法の併用に関する国際共同第III相試験

募集中NCT06692738第3相

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

対象疾患:
Non-small Cell Lung Cancer

免疫グロブリンA腎症(IgAN)の成人におけるポベタシセプトの有効性評価

実施中(募集終了)NCT06564142第3相

The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.

対象疾患:
Immunoglobulin A Nephropathy

試験食品の長期摂取の安全性を評価するための検証研究

実施中(募集終了)NCT06715475該当なし

This clinical study aims to verify the safety of consumption of plasmalogen-containing food for 12 weeks in healthy Japanese. The study will also exploratory assess blood plasmalogen levels and the effects of plasmalogen-containing food on sleep.

対象疾患:
Healthy Japanese

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)

JAVEMACS: 日本アベルマブ維持療法および継続治療試験

実施中(募集終了)NCT06412848

This study is a multicenter, non-interventional, retrospective, medical chart review of locally advanced or metastatic (la/m) Urothelial Cancer UC participants who were prescribed avelumab as first line maintenance therapy after a platinum-based chemotherapy. This study aims to understand the index date (i.e., at the initiation of avelumab maintenance therapy) demographics and clinical characteristics of participants with locally advanced/metastatic Urothelial Carcinoma in Japan, and to describe their treatment patterns and outcomes.

対象疾患:
Urothelial Carcinoma

転移性膵臓癌患者における第一選択治療として、標準治療である修正FOLFIRINOX(mFFX)またはゲムシタビン+ナブパクリタキセル(GnP)療法とONO-4578およびONO-4538の併用療法を評価する非盲検非対照試験

完了NCT06538207第1相

This study is a multicenter, open-label, uncontrolled study to investigate the tolerability and safety of ONO-4578, ONO-4538, and standard of care in combination as first-line treatment in patients with metastatic pancreatic cancer.

対象疾患:
Metastatic Pancreatic Cancer

NMNを用いた胚発生能力向上効果を調査する。

募集中NCT06629636該当なし

The objective of this study is to investigate the efficacy of NMN supplementation in enhancing embryo developmental capacity and improving IVF success rates in patients experiencing IVF failures.

対象疾患:
Female InfertilityRepeated IVF Failure

潰瘍性大腸炎におけるLRGと組織学的寛解との関連

募集中NCT06372613

We attempt to clarify the serum leucine-rich α 2-glycoprotein (LRG) level which can predict histologic remission in ulcerative colitis patients in this study. Colonoscopy with histology will be performed when histologic remission is predicted, irrespective of symptoms or serum LRG values. Serum LRG levels are analyzed by an enzyme-linked immunosorbent assay.

対象疾患:
Ulcerative Colitis in Histologic Remission

中等度リスク非筋層浸潤性膀胱癌患者におけるナドファラゲン・フィラデノベックと経過観察の試験

募集中NCT06510374第3相

A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

対象疾患:
中等度リスクの非筋層浸潤性膀胱がん

早期乳がんに対する新規治療法開発のための持続的かつ効率的なプラットフォーム試験

募集中NCT06535893第2相

Randomized phase II trial targeting early-stage breast cancer (stage II-III) applicable to preoperative chemotherapy (NAC), comparing standard treatment with multiple experimental treatments.

対象疾患:
Breast Cancer