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 in male adults with hemophilia B who were treated with CSL222 in 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

  • Treatment with CSL222 in Study CSL222_2001 or Study CSL222_3001.
  • Provided written informed consent.
  • Willing and able to adhere to all protocol requirements.

You CAN'T join if...

Locations

  • UC Davis Medical Center
    Sacramento California 95817 United States
  • University of California, San Diego (UCSD)
    San Diego California 92121 United States
  • Arkansas Children's Hospital - Pharmacology
    Little Rock Arkansas 72202 United States
  • University of Michigan Medical Center
    Ann Arbor Michigan 48109 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