A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

July 29, 2019

Primary Completion Date

November 16, 2022

Study Completion Date

February 25, 2031

Conditions
Hemophilia B
Interventions
BIOLOGICAL

PF-06838435/ fidanacogene elaparvovec

Gene Therapy

Trial Locations (60)

500

Changhua Christian Hospital, Changhua

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

2050

Royal Prince Alfred Hospital, Camperdown

3004

The Alfred Hospital, Melbourne

4029

Royal Brisbane and Women's Hospital, Herston

5000

Royal Adelaide Hospital, Adelaide

6150

Fiona Stanley Hospital, Murdoch

10002

National Taiwan University Hospital, Taipei

10249

Vivantes Klinikum Friedrichshain, Berlin

Vivantes Klinikum im Friedrichshain, Berlin

11527

"General Hospital of Athens LAIKO, 2nd Regional Blood Transfusion Center", Athens

14611

King Abdulaziz Medical City-Ministry of national guard, Riyadh

19104

Center for Human Phenomic Science CHPS, Philadelphia

Center for Human Phenomic Science, Philadelphia

Investigational Drug Service, Philadelphia

Penn Blood Disorder Center, Philadelphia

27310

Gaziantep University Sahinbey Training and Research Hospital, Gaziantep

30120

Hospital Universitario Virgen de la Arrixaca, El Palmar

34093

Istanbul University Oncology Institute, Istanbul

35040

Ege University Medical Faculty Hospital, Izmir

39110

Madison Radiological Group, Madison

Mississippi Center for Advanced Medicine, Madison

40201

Chung Shan Medical University Hospital, Taichung

Chung Shan Medical University, Taichung

40705

Taichung Veterans General Hospital, Taichung

46260

Indiana Hemophilia & Thrombosis Center, Inc., Indianapolis

Indiana Hemophilia and Thrombosis Center, Inc, Indianapolis

St. Vincent Hospital & Health Care Center, Inc., Indianapolis

50134

Azienda Ospedaliero Universitaria Careggi, Florence

53127

Universitaetsklinikum Bonn, Bonn

Universitätsklinikum Bonn, Anstalt des öffentlichen Rechts, Bonn

Universitätsklinikum Bonn, Bonn

69677

Hopital Cardiologique Louis Pradel - CRTH, Bron

75015

Hopital Necker, Paris

80045

Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical Campus, Aurora

80131

Azienda Ospedaliera Universitaria Federico II, Naples

94143

University of California, San Francisco - Clinical Research Center, San Francisco

University of California, San Francisco - Outpatient Hematology Clinic, San Francisco

29047-105

Centro Estadual de Hemoterapia e Hematologia Marcos Daniel Santos - Hemoes, Vitória

13083-878

Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP, Campinas

05403-010

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo

20211-030

Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti- HEMORIO, Rio de Janeiro

L8N 3Z5

McMaster University Medical Centre - Hamilton Health Sciences, Hamilton

L8V 1C3

Juravinski Hospital - Hamilton Health Sciences, Hamilton

M5B 1W8

St. Michael's Hospital, Toronto

004-0041

Sapporo Tokushukai Hospital, Sapporo

634-8522

Nara Medical University Hospital, Kashihara

350-0495

Saitama Medical University Hospital, Iruma-gun

157-8535

National Center for Child Health and Development, Setagaya-ku

Unknown

King Faisal Specialist Hospital and Research Centre, Riyadh

05278

Kyung Hee University Hospital at Gangdong, Seoul

08035

Hospital Universitari Vall d´Hebrón, Barcelona

205 02

Skåne University Hospital, Department of Hematology, Oncology and Radiation Physics, Malmo

211 24

ApoEx AB, Malmo

01130

Acibadem Adana Hospital, Adana

NE1 4LP

Newcastle upon Tyne Hospitals NHS FT, Newcastle upon Tyne

NE2 4HH

Newcastle upon Tyne Hospitals NHS FT, Newcastle upon Tyne

Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

G4 0SF

Glasgow Royal Infirmary, Glasgow

SE1 7EH

Guy's and St. Thomas' NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT03861273 - A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B | Biotech Hunter | Biotech Hunter