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Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)
Sponsor: CSL Behring
Summary
The primary purpose of this study is to assess the long-term safety and efficacy in male adults with hemophilia B who were treated with CSL222 (CSL222) in parent studies CSL222\_2001 (NCT03489291) or CSL222\_3001 (NCT03569891).
Official title: An Extension Study Assessing the Long-term Safety and Efficacy of Etranacogene Dezaparvovec (CSL222) Previously Administered to Adult Male Subjects With Hemophilia B
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
56
Start Date
2023-08-30
Completion Date
2035-03-23
Last Updated
2025-07-18
Healthy Volunteers
No
Conditions
Interventions
AAV5-hFIXco-Padua
Single intravenous infusion of AAV5-hFIXco-Padua in the study CSL222\_2001 (NCT03489291) or CSL222\_3001 (NCT03569891).
Locations (28)
10-15 Phoenix Childrens Hospital
Phoenix, Arizona, United States
10-14 Arkansas Children's Hospital - Pharmacology
Little Rock, Arkansas, United States
10-22 Orthopaedic Institute for Children
Los Angeles, California, United States
10-21 Children's Hospital of Los Angeles
Los Angeles, California, United States
10-63 UC Davis Medical Center
Sacramento, California, United States
10-12 University of California, San Diego (UCSD)
San Diego, California, United States
10-25 University of Colorado Denver
Aurora, Colorado, United States
10-19 University of South Florida
Tampa, Florida, United States
10-10 University of Michigan Medical Center
Ann Arbor, Michigan, United States
10-16 University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
10-18 Oregon Health & Science University
Portland, Oregon, United States
10-20 Vanderbilt University Medical Center
Nashville, Tennessee, United States
10-28 University of Texas Health Science Center
Houston, Texas, United States
10-26 University of Utah
Salt Lake City, Utah, United States
10-62 Washington Institute for Coagulation
Seattle, Washington, United States
11-31 Cliniques Universitaires Saint-Luc
Brussels, Belgium
11-30 Universitair Ziekenhuis Leuven
Leuven, Belgium
12-32 Rigshospitalet
Copenhagen, Denmark
15-42 Vivantes Klinikum im Friedrichshain - Landsberger Allee
Berlin, Germany
19-56 St. James Hospital
Dublin, Ireland
13-33 Amsterdam Universitair Medische Centra (UMC)
Amsterdam-Zuidoost, Netherlands
13-35 University Medical Center Groningen
Groningen, Netherlands
13-34 Erasmus University Medical Center
Rotterdam, Netherlands
13-36 Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
16-43 Skane University Hospital
Malmo, Sweden
18-52 Barts Health NHS Trust
London, England, United Kingdom
18-54 Addenbrooke's Hospital
Cambridge, United Kingdom
18-53 University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom