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
Recruiting · Phase 3 · NCT07080905
Conditions: Hemophilia B
At a glance
- Research payments reported, 2025
- $111,182
- U.S. investigators named
- 5
- Sites paid
- 5
- Planned or actual enrollment
- 20
About the trial
- Sponsor
- CSL Behring
- Tested
- CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua) (genetic)
- Dates
- Started 2025-07-28; completion 2033-10-24
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-10-20. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Csl Behring reported $111,182 in research payments for this study in 2025 (36 payments).
Products named: Hemgenix
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Amit Soni, M.D Pediatric Hematology & Oncology · Orange, CA
- Tung T. Wynn, M.D. Pediatric Hematology & Oncology · Gainesville, FL
- Robert Sidonio JR., MD Pediatric Hematology & Oncology · Atlanta, GA
- Steven W. Pipe, MD Pediatric Hematology & Oncology · Ann Arbor, MI
- Rohith Jesudas, M.D., Pediatric Hematology & Oncology · Memphis, TN
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- University of Michigan Health System, MI $82,893
- St Jude Children's Research Hospital $24,480
- University of Florida $1,721
- Center for Inherited Blood Disorder $1,044
- Children's Healthcare of Atlanta Inc $1,044
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.