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

CSL Behring logo

CSL Behring

Status

Invitation-only

Conditions

Hemophilia B

Treatments

Genetic: AAV5-hFIXco-Padua

Study type

Observational

Funder types

Industry

Identifiers

NCT05962398
CSL222_3003

Details and patient eligibility

About

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).

Enrollment

56 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

-

Trial design

56 participants in 1 patient group

CSL222
Description:
Participants who received CSL222 and completed either the study CSL222_2001 (NCT03489291) or CSL222_3001 (NCT03569891) will be followed up from Year 5 after administration of CSL222 in parent study up to Year 15.
Treatment:
Genetic: AAV5-hFIXco-Padua

Trial contacts and locations

0

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Central trial contact

Trial Registration Coordinator

Data sourced from clinicaltrials.gov

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