Status:
COMPLETED
Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia
Lead Sponsor:
Catalyst Biosciences
Conditions:
Hemophilia A
Eligibility:
MALE
18-64 years
Phase:
PHASE1
Brief Summary
This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe to administer to subjects with severe Hemophilia A or B with or without inhibitors and will demonstrate ev...
Eligibility Criteria
Inclusion
- Male subjects 18 to \<65 years old with severe hemophilia A or B with or without inhibitors to FVIII or FIX.
- Subjects is willing and able to comply with the mandatory washout periods prior to screening and prior to dosing and through 48 hours post dosing. At screening this includes a washout of FIX for 96 hours and FVIII for 72 houts. At dosing this includes a washout of FIX for 96 hours and FVIII and other hemostatic agents for 72 hours through 48 hours post dosing.
- Subjects must agree and commit to using a a highly effective method of birth control from the time of screening through four weeks after study drug administration.
Exclusion
- Presence of a bleeding disorder in addition to hemophilia A or B.
- Regular, concomitant therapy with immunomodulating drugs (eg, intravenous immunoglobulin, and routine systemic corticosteroids).
- History of coronary artery disease, thrombolic disease or diagnosis of prothrombic disorder.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01439971
Start Date
December 1 2011
End Date
October 1 2015
Last Update
May 12 2017
Active Locations (23)
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1
University of California San Diego Medical Center
San Diego, California, United States, 92103-8651
2
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229