This study is accepting new patients by invitation only

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

a study on Hemophilia

Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UC Davis UCSD
Dates
study started
completion around

Description

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

Keywords

Hemophilia B, Hemophilia A, AAV5-hFIXco-Padua

Eligibility

You can join if…

Open to males ages 18 years and up

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 CAN'T join if...

Not Applicable

Locations

  • UC Davis Medical Center
    Sacramento California 95817 United States
  • University of California, San Diego (UCSD)
    San Diego California 92121 United States
  • Orthopaedic Institute for Children
    Los Angeles California 90007 United States
  • Children's Hospital of Los Angeles
    Los Angeles California 90027 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
CSL Behring
ID
NCT05962398
Study Type
Observational
Participants
Expecting 56 study participants
Last Updated