Okayama-city, Japan
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
This is an event driven, randomized, controlled, prospective, single blinded (non-blinded in Canada), multi-national study. This study is designed to demonstrate that the AGN1 LOEP treatment can reduce the incidence of secondary hip fractures in subjects presenting with an index hip fracture and undergoing hip fracture repair surgery. Subjects presenting with an index fragility hip fracture who will undergo hip fracture repair will be enrolled. Subjects will be randomized 1:1 into the following two study groups: 1. Treated Group - receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip 2. Control Group - receives standard of care to repair the index hip fracture and no AGN1 LOEP treatment on the target unfractured contralateral hip AGN1 LOEP is an elective procedure that will be performed immediately following hip fracture repair. Subjects will be followed through scheduled visits conducted at 6 weeks, 6 months, and every 6 months thereafter for a minimum of 5 years.
Phase
N/ASpan
415 weeksSponsor
AgNovos Healthcare, LLCMarugame, Kagawa
Recruiting
Marugame, Kagawa
Recruiting
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Cohort C(All Countries) : An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled 115 patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease BCG failure is defined as a persistent or recurrent disease within 12 months of completion of adequate BCG therapy. Cohort P(Japan and the United States Only): To determine the all-cause High Grade Event Free Survival (HG-EFS) of cretostimogene in up to 75 patients with BCG-unresponsive HG Ta/T1 papillary disease without CIS. BCG failure is defined as a persistent or recurrent disease within 6 months of completion of adequate BCG therapy.
Phase
3Span
478 weeksSponsor
CG Oncology, Inc.Marugame
Recruiting
Marugame, Kagawa
Recruiting
Marugame, Kagawa
Recruiting
A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab
Phase
3Span
94 weeksSponsor
AbbVieMarugame, Kagawa
Recruiting