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Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B
Sponsor: Pfizer
Summary
Long-term safety and efficacy follow-up for participants with Hemophilia B who were previously treated in the C0371005 (formerly SPK-9001-101) study, and a dose-escalation sub-study evaluating safety, tolerability, and kinetics of a higher dose with long-term safety and efficacy follow-up. Participants in the substudy do not need to have participated in C0371005.
Official title: A FACTOR IX (FIX) GENE TRANSFER, MULTI CENTER EVALUATION OF THE LONG TERM SAFETY AND EFFICACY STUDY OF PF 06838435 AND A DOSE ESCALATION SUBSTUDY IN INDIVIDUALS WITH HEMOPHILIA B
Key Details
Gender
MALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2017-06-22
Completion Date
2029-10-25
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
PF-06838435 (formerly SPK-9001)
Gene Therapy: A novel, bioengineered adeno-associated viral vector carrying human factor IX variant
Locations (25)
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
UC Davis Ellison Ambulatory Care Clinic
Sacramento, California, United States
UC Davis Medical Center department of Radiology
Sacramento, California, United States
UC Davis Medical Center
Sacramento, California, United States
UC Davis Midtown Cancer Center
Sacramento, California, United States
UC DavisHealth Main Hospital
Sacramento, California, United States
LA Center for Bleeding and Clotting Disorders - Metairie
Metairie, Louisiana, United States
Tulane Lakeside Hospital
Metairie, Louisiana, United States
LA Center for Bleeding and Clotting Disorders
New Orleans, Louisiana, United States
Tulane University Clinical Translational Unit
New Orleans, Louisiana, United States
Tulane University Hospitals and Clinic
New Orleans, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Louisiana Center for Advanced Medicine
Slidell, Louisiana, United States
Mississippi Center for Advanced Medicine
Madison, Mississippi, United States
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
McMaster University Medical Centre - Hamilton Health Sciences
Hamilton, Ontario, Canada
McMaster University
Hamilton, Ontario, Canada
The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
McGill University Health Center - Research Institute
Montreal, Quebec, Canada
Istanbul Universitesi Onkoloji Enstitusu Çocuk Hematoloji Onkoloji Bilim Dali
Istanbul, Turkey (Türkiye)
Istanbul University Clinical Trials Excellence Center
Istanbul, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Cocuk Sagligi ve Hastaliklari Anabilim Dali
Izmir, Turkey (Türkiye)