Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)

Enrolling by invitation

Conditions studied: Hemophilia B

In brief

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).

Key facts

Study ID: NCT05962398
Run by: CSL Behring
People needed: 56
Starts: 2023-08-30
Expected to finish: 2035-03-23
Last updated by the study team: 2025-07-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Received treatment with CSL222 in Study CSL222_2001 or Study CSL222_3001, and completed participation in Study CSL222_2001 or Study CSL222_3001 or at least 5 years have passed since receiving CSL222.

You may not qualify if…

Not Applicable

Where it is running

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 — Malmö, Sweden

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.