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

Pfizer

Status and phase

Terminated

Phase 4

Conditions

Hemophilia A

Treatments

Drug: moroctocog alfa (AF-CC) (ReFacto AF)

Procedure: Laboratory tests

Study type

Interventional

Funder types

Industry

Identifiers

NCT00884390

3082B2-4432

Details and patient eligibility

About

The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.

Full description

The trial was terminated prematurely on 28 March 2013, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy concerns and agreement to close the study in March 2013 was agreed with EMA prior to closure activity.

Enrollment

208 patients

Sex

Male

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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.