clinical trial · NCT07080905
Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B
CSL Behring·phase3·recruiting·n = 20
Hemophilia BCSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua)
brief summary
This is a phase 3, prospective, open-label, single-arm, single-dose, multicenter study investigating the efficacy, safety, and tolerability of CSL222 (AAV5-hFIXco-Padua) in adolescent male participants with severe or moderately severe hemophilia B.
started
Jul 28, 2025
primary completion
Oct 24, 2033
completion
Oct 24, 2033
last updated
May 11, 2026
official title
Phase 3, Open-label, Single-dose, Multicenter Study Investigating Efficacy, Safety, and Tolerability of CSL222 (Etranacogene Dezaparvovec) Administered to Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol