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NCT03307980

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

Study 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.

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Interventions

PF-06838435 (formerly SPK-9001)BIOLOGICAL
Gene Therapy: A novel, bioengineered adeno-associated viral vector carrying human factor IX variant

Study Locations

FacilityCityStateCountry
UC Davis Comprehensive Cancer CenterSacramentoCaliforniaUnited States
UC Davis Ellison Ambulatory Care ClinicSacramentoCaliforniaUnited States
UC Davis Medical Center department of RadiologySacramentoCaliforniaUnited States
UC Davis Medical CenterSacramentoCaliforniaUnited States
UC Davis Midtown Cancer CenterSacramentoCaliforniaUnited States
UC DavisHealth Main HospitalSacramentoCaliforniaUnited States
LA Center for Bleeding and Clotting Disorders - MetairieMetairieLouisianaUnited States
Tulane Lakeside HospitalMetairieLouisianaUnited States
LA Center for Bleeding and Clotting DisordersNew OrleansLouisianaUnited States
Tulane University Clinical Translational UnitNew OrleansLouisianaUnited States
Tulane University Hospitals and ClinicNew OrleansLouisianaUnited States
Tulane University School of MedicineNew OrleansLouisianaUnited States
University Medical Center New OrleansNew OrleansLouisianaUnited States
Louisiana Center for Advanced MedicineSlidellLouisianaUnited States
Mississippi Center for Advanced MedicineMadisonMississippiUnited States
Weill Cornell Medicine - New York Presbyterian HospitalNew YorkNew YorkUnited States
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States
Royal Prince Alfred HospitalCamperdownNew South WalesAustralia
McMaster University Medical Centre - Hamilton Health SciencesHamiltonOntarioCanada
McMaster UniversityHamiltonOntarioCanada
The Research Institute of the McGill University Health CentreMontrealQuebecCanada
McGill University Health Center - Research InstituteMontrealQuebecCanada
Istanbul Universitesi Onkoloji Enstitusu Çocuk Hematoloji Onkoloji Bilim DaliIstanbulTurkey (Türkiye)
Istanbul University Clinical Trials Excellence CenterIstanbulTurkey (Türkiye)
Ege Universitesi Tip Fakultesi Cocuk Sagligi ve Hastaliklari Anabilim DaliIzmirTurkey (Türkiye)

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026