Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062334) titled 'A Retrospective Observational Study Evaluating Treatment Response in Patients with PNH on Anti-C5 Antibody Therapy: Japanese Chart Review Study' on July 31.

Study Type: Observational

Primary Sponsor: Institute - Japan PNH Study Group / Novartis Pharma K.K.

Condition: Condition - Paroxysmal Nocturnal Hemoglobinuria Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Although anti-C5 antibody therapy has improved treatment outcomes in PNH, anemia and hemolysis-related symptoms may persist in some patients with PNH. This study aimed to characterize real-world treatment responses to anti-C5 antibody therapy in Japan and to identify factors associated with suboptimal responses, thereby clarifying remaining unmet needs and opportunities for treatment optimization. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients who were diagnosed with PNH at the participating institution and were 18 years of age or older at the initiation of anti-C5 antibody therapy, defined as the index date 2) Patients who had a confirmed diagnosis of PNH before the index date based on flow cytometry and LDH levels 3) PNH patients who had continued anti-C5 antibody therapy for at least 6 months, or who had previously received anti-C5 antibody therapy for PNH for at least 6 months 4) Patients who had at least two Hb measurements during the observation period after the index date, with at least one Hb measurement performed within +- 1 month of 6 months after the index date Key exclusion criteria - 1) Patients known or suspected to have a C5 gene polymorphisms when treated with an anti-C5 antibody that recognizes the C5 MG7 domain 2) Patients who participated in any clinical trial within 6 months after the index date 3) Any other patients deemed ineligible by the principal investigator or sub-investigator Target Size - 70

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 05 Month 13 Day Date of IRB - 2025 Year 05 Month 21 Day Anticipated trial start date - 2025 Year 10 Month 08 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071123

Disclaimer: Curated by HT Syndication.