Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
NCT ID: NCT05568719
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
263 participants
INTERVENTIONAL
2022-12-28
2040-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Hemophilia A / giroctocogene fitelparvovec
Participants have received treatment with giroctocogene fitelparvovec in a previous study and are not receiving any investigational product in this study
Testing of hepatic AAV Vector integration
Evaluation of AAV vector integration in participants for whom a sample of liver has been obtained through biopsy or surgical resection when clinically indicated
Hemophilia B / fidanacogene elaparvovec
Participants have received treatment with fidanacogene elaparvovec in a previous study and are not receiving any investigational product in this study
Testing of hepatic AAV Vector integration
Evaluation of AAV vector integration in participants for whom a sample of liver has been obtained through biopsy or surgical resection when clinically indicated
Interventions
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Testing of hepatic AAV Vector integration
Evaluation of AAV vector integration in participants for whom a sample of liver has been obtained through biopsy or surgical resection when clinically indicated
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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UC Davis Health
Sacramento, California, United States
UC Davis Ambulatory Care Clinic
Sacramento, California, United States
UC Davis Hemophilia Treatment Center
Sacramento, California, United States
UC Davis Medical Center
Sacramento, California, United States
UCSF Outpatient Hematology Clinic
San Francisco, California, United States
USF Health Morsani Center For Advanced Healthcare
Tampa, Florida, United States
Mississippi Center For Advanced Medicine
Madison, Mississippi, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States
The Childrens Hospital of Philadelphia Division of Hematology
Philadelphia, Pennsylvania, United States
Washington Institute for Coagulation
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Ege Universitesi Hastanesi
Izmir, İ̇zmir, Turkey (Türkiye)
Countries
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Central Contacts
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References
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Berntorp E, Shapiro AD. Modern haemophilia care. Lancet. 2012 Apr 14;379(9824):1447-56. doi: 10.1016/S0140-6736(11)61139-2. Epub 2012 Mar 27.
WFH guidelines: https://www1.wfh.org/publication/files/pdf-1472.pdf
Blanchette VS, Key NS, Ljung LR, Manco-Johnson MJ, van den Berg HM, Srivastava A; Subcommittee on Factor VIII, Factor IX and Rare Coagulation Disorders of the Scientific and Standardization Committee of the International Society on Thrombosis and Hemostasis. Definitions in hemophilia: communication from the SSC of the ISTH. J Thromb Haemost. 2014 Nov;12(11):1935-9. doi: 10.1111/jth.12672. Epub 2014 Sep 3. No abstract available.
Blanchette VS, McCready M, Achonu C, Abdolell M, Rivard G, Manco-Johnson MJ. A survey of factor prophylaxis in boys with haemophilia followed in North American haemophilia treatment centres. Haemophilia. 2003 May;9 Suppl 1:19-26; discussion 26. doi: 10.1046/j.1365-2516.9.s1.12.x.
Lillicrap D. Extending half-life in coagulation factors: where do we stand? Thromb Res. 2008;122 Suppl 4:S2-8. doi: 10.1016/S0049-3848(08)70027-6.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT05568719
Identifier Type: REGISTRY
Identifier Source: secondary_id
C0371017
Identifier Type: -
Identifier Source: org_study_id
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