You are here

Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings

Last updated on February 23, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Wien, , 1090 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male patients greater than or equal to 12 years of age with severe hemophilia A
(FVIII:C less than 1%).

- Treatment history of greater than 150 EDs to prior recombinant or plasma-derived FVIII
replacement products.

- Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII
replacement products.

- Serum albumin greater than or equal to the lower limit of normal (LLN).

- Platelet count greater than or equal to 100,000/µL.

- Prothrombin time (PT) less than or equal to1.25 × ULN, or international normalized
ratio (INR) less than or equal to 1.5.

- HIV positive subjects must have a CD4 count greater than 200/µL and HIV viral load
less than 200 particles/µL.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Presence of any bleeding disorder in addition to hemophilia A.

- A positive FVIII inhibitor, according to the local laboratory, at screening; or any
Bethesda Inhibitor Titer greater than 0.6, regardless of the normal range for the
testing laboratory.

- Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI])
during the screening period.

- Prior exposure to moroctocog alfa (AF-CC).

- Known hypersensitivity to hamster protein.

NCT00884390
Pfizer
Terminated
Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Hemophilia A
NCT00884390
Males
12+
Years
Multiple Sites
Hemophilia A
NCT00895037
All Genders
0+
Years
Multiple Sites
Hemophilia A, Hemophilia B
NCT00581438
All Genders
Hemophilia A
NCT00038909
All Genders

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now