Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs)

PHASE3RecruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

January 30, 2024

Primary Completion Date

October 4, 2028

Study Completion Date

April 2, 2032

Conditions
Hemophilia B
Interventions
GENETIC

CSL222 (AAV5-hFIXco-Padua)

Administered as a single IV infusion.

Trial Locations (23)

114

RECRUITING

Tri-Service General Hospital - 15800012, Taipei

500

RECRUITING

Changhua Christian Hospital (CCH) - 15800009, Chang-hua

2050

RECRUITING

Royal Prince Alfred Hospital - 03600044, Camperdown

2193

RECRUITING

Haemophilia Comprehensive Care Centre - 71000001, Johannesburg

3004

RECRUITING

The Alfred Hospital - 03600043, Melbourne

3720

RECRUITING

Centro de Investigacion Clinica GRAMEL S.C. - 48400003, Mexico City

3722

RECRUITING

Severance Hospital, Yonsei University Health System - 41000013, Seoul

4029

RECRUITING

Royal Brisbane Hospital - 03600045, Herston

11471

RECRUITING

King Faisal Specialist Hospital and Research Center - 68200001, Riyadh

27310

RECRUITING

Gaziantep University Sahinbey Research and Practice Hospital - 79200004, Gaziantep

35100

RECRUITING

Ege University Medical Faculty - 79200002, Bornova

40705

RECRUITING

Taichung Veterans General Hospital - 15800007, Taichung

41944

RECRUITING

Kyungpook National University Hospital - 41000014, Daegu

48109

RECRUITING

University of Michigan - 84000285, Ann Arbor

80756

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH) - 15800011, Kaohsiung City

92121

RECRUITING

University of California, San Diego (UCSD) - 84000460, San Diego

110974

RECRUITING

National University Hospital - 70200002, Singapore

999077

RECRUITING

Queen Mary Hospital - 34400001, Hong Kong

RECRUITING

Prince of Wales Hospital Chinese University of Hong Kong - 34400002, Shatin

5265601

RECRUITING

Sheba Medical Center - 37600004, Tel Litwinsky

L8N 3Z5

RECRUITING

McMaster University - Hamilton - 12400017, Hamilton

05278

RECRUITING

Kyung Hee University Hospital at Gangdong - 41000015, Seoul

01130

RECRUITING

Özel Acibadem Adana Hastanesi - 79200003, Seyhan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY