Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

June 22, 2017

Primary Completion Date

June 8, 2029

Study Completion Date

June 8, 2029

Conditions
Hemophilia B
Interventions
BIOLOGICAL

PF-06838435 (formerly SPK-9001)

Gene Therapy: A novel, bioengineered adeno-associated viral vector carrying human factor IX variant

Trial Locations (22)

2050

Royal Prince Alfred Hospital, Camperdown

10065

Weill Cornell Medicine - New York Presbyterian Hospital, New York

19104

The Children's Hospital of Philadelphia, Philadelphia

34093

Istanbul Universitesi Onkoloji Enstitusu Çocuk Hematoloji Onkoloji Bilim Dali, Istanbul

35100

Ege Universitesi Tip Fakultesi Cocuk Sagligi ve Hastaliklari Anabilim Dali, Izmir

39110

Mississippi Center for Advanced Medicine, Madison

70001

LA Center for Bleeding and Clotting Disorders - Metairie, Metairie

Tulane Lakeside Hospital, Metairie

70112

LA Center for Bleeding and Clotting Disorders, New Orleans

Tulane University Clinical Translational Unit, New Orleans

Tulane University Hospitals and Clinic, New Orleans

Tulane University School of Medicine, New Orleans

University Medical Center New Orleans, New Orleans

70461

Louisiana Center for Advanced Medicine, Slidell

95817

UC Davis Comprehensive Cancer Center, Sacramento

UC Davis Ellison Ambulatory Care Clinic, Sacramento

UC Davis Medical Center department of Radiology, Sacramento

UC Davis Medical Center, Sacramento

UC Davis Midtown Cancer Center, Sacramento

UC DavisHealth Main Hospital, Sacramento

L8N 3Z5

McMaster University Medical Centre - Hamilton Health Sciences, Hamilton

H4A 3J1

McGill University Health Center - Research Institute, Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY