Gamagori-city, Japan
TEZSPIRE (Tezepelumab) Asthma Japan Post-Marketing Study (PMS)
The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire. 1. Development of related AEs 2. Contributing factors possibly having an impact on the safety and effectiveness 3. Development of unexpected related AEs This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices.
Phase
N/ASpan
346 weeksSponsor
AstraZenecaYamanashi
Recruiting
A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
Phase
3Span
373 weeksSponsor
Hoffmann-La RocheYamanashi
Recruiting
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Phase
3Span
440 weeksSponsor
Janssen Research & Development, LLCYamanashi
Recruiting
Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
This investigation will be conducted to collect information of safety in patients with unresectable hepatocellular carcinoma (HCC) treated with the combination therapy of IMJUDO 25 mg, 300 mg and IMFINZI Intravenous Infusion 120 mg, 500 mg or with IMFINZI monotherapy under actual use in the post-marketing setting. The investigation will be conducted as one of the additional pharmacovigilance activities in the Japan Risk Management Plan of IMJUDO and IMFINZI in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for reexamination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
Phase
N/ASpan
191 weeksSponsor
AstraZenecaYamanashi
Recruiting
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
The primary objectives of the study are Progression Free Survival (PFS) and Overall Survival (OS) as first line therapy in participants with programmed death-ligand 1 (PD-L1) TPS <50% and advanced or metastatic NSCLC without actionable genomic alternations. Eligible participants will be randomized in a 1:1:1 ratio to a) Dato-DXd plus pembrolizumab plus platinum; b) Dato-DXd plus pembrolizumab; or c) pembrolizumab plus pemetrexed plus platinum. Platinum therapy will be either carboplatin or cisplatin at investigator discretion. The study will be divided into three periods: Screening Period (including tissue screening), Treatment Period, and Follow-up Period.
Phase
3Span
238 weeksSponsor
Daiichi SankyoYamanashi
Recruiting
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
Phase
3Span
575 weeksSponsor
Janssen Research & Development, LLCYamanashi
Recruiting
Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)
This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions. 1. Detection of unknown adverse drug reactions 2. Incidence of adverse drug reactions under actual use conditions of the drug 3. Factors that may affect the safety or effectiveness "Safety specification" Thrombotic events, Infusion reaction, re-bleeding
Phase
N/ASpan
157 weeksSponsor
AstraZenecaYamanashi
Recruiting
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
Phase
3Span
238 weeksSponsor
Ono Pharmaceutical Co. LtdYamanashi
Recruiting
A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
Phase
3Span
222 weeksSponsor
GlaxoSmithKlineYamanashi
Recruiting
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Phase
2Span
155 weeksSponsor
GlaxoSmithKlineYamanashi
Recruiting