Tokyo, Feb. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060690) titled 'Drug Use-Results Survey of ELEVIDYS for Injection (All-Patient Surveillance)' on Feb. 17.
Study Type:
Observational
Primary Sponsor:
Institute - Chugai Pharmaceutical Co. Ltd.
Condition:
Condition - Duchenne Muscular Dystrophy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The primary objective is to understand the long-term safety profile (incidence rate, time of onset, outcome, etc.) of this product under real-world usage conditions. Secondarily, long-term efficacy parameters will also be assessed.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - All patients who are scheduled to receive this product until a decision is made on the new approval application within the time limit of conditional and time-limited approval. If a patient receiving this product transfers to another hospital (including cases where they are concurrently examined for Duchenne Muscular Dystrophy (DMD) at another facility) during the observation period, registration should also be conducted at the transfer destination medical institution.
Key exclusion criteria - None
Target Size - 86
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 16 Day
Anticipated trial start date - 2026 Year 02 Month 20 Day
Last follow-up date - 2028 Year 05 Month 13 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066752
Disclaimer: Curated by HT Syndication.
