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

Condition(s) targeted: Hemophilia A

Intervention: moroctocog alfa (AF-CC) (ReFacto AF) (Drug); Laboratory tests (Procedure)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

Official title: A Postauthorization Safety Surveillance Study Of Patients Switching To ReFacto AF From ReFacto Or Other Factor VIII Products In Usual Care Settings

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Development of clinically significant factor VIII inhibitors

Secondary outcome:

Occurence of adverse events and serious adverse events during the study

Annualized bleed rates

Response to first on-demand treatment with test article for all new bleeding episodes

number of test article infusions required for each bleeding episode

number of breakthrough bleeding episodes within 48 hours of a prophylaxis treatment

Average infusion dose and the total factor consumption

Incidence of less-than-expected-therapeutic effect (LETE)

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Wien 1090, Austria; Completed

Pfizer Investigational Site, Brussels 1020, Belgium; Completed

Pfizer Investigational Site, Bruxelles 1200, Belgium; Completed

Pfizer Investigational Site, Leuven 3000, Belgium; Completed

Pfizer Investigational Site, Copenhagen 2100, Denmark; Completed

Pfizer Investigational Site, Helsinki 00029 HUS, Finland; Completed

Pfizer Investigational Site, Kuopio 70211, Finland; Completed

Pfizer Investigational Site, Chambray Les Tours Cedex 37170, France; Terminated

Pfizer Investigational Site, Clermont Ferrand Cedex 1 63003, France; Terminated

Pfizer Investigational Site, Clermont-Ferrand Cedex 1 63003, France; Terminated

Pfizer Investigational Site, Le Chesnay 78157, France; Completed

Pfizer Investigational Site, Le Kremlin Bicetre Cedex 94275, France; Completed

Pfizer Investigational Site, Limoges Cedex 1 87042, France; Completed

Pfizer Investigational Site, Lyon Cedex 03 69437, France; Completed

Pfizer Investigational Site, Marseille Cedex 05 13385, France; Active, not recruiting

Pfizer Investigational Site, Montmorency 95160, France; Terminated

Pfizer Investigational Site, Montpellier Cedex 5 34295, France; Completed

Pfizer Investigational Site, Nantes 44093, France; Completed

Pfizer Investigational Site, Paris Cedex 15 75743, France; Completed

Pfizer Investigational Site, Berlin 10249, Germany; Completed

Pfizer Investigational Site, Bonn 53127, Germany; Completed

Pfizer Investigational Site, Bremen 28177, Germany; Completed

Pfizer Investigational Site, Dresden 01307, Germany; Completed

Pfizer Investigational Site, Frankfurt am Main 60596, Germany; Completed

Pfizer Investigational Site, Fulda 36043, Germany; Completed

Pfizer Investigational Site, Halle 06120, Germany; Completed

Pfizer Investigational Site, Hamburg 20246, Germany; Completed

Pfizer Investigational Site, Heidelberg 69123, Germany; Completed

Pfizer Investigational Site, Homburg 66421, Germany; Completed

Pfizer Investigational Site, Leipzig 04103, Germany; Completed

Pfizer Investigational Site, Leipzig 04289, Germany; Completed

Pfizer Investigational Site, Magdeburg 39112, Germany; Completed

Pfizer Investigational Site, Muenchen 80336, Germany; Completed

Pfizer Investigational Site, Muenchen 80337, Germany; Completed

Pfizer Investigational Site, Muenster 48143, Germany; Completed

Pfizer Investigational Site, Rostock 18059, Germany; Completed

Pfizer Investigational Site, Stuttgart 70176, Germany; Completed

Pfizer Investigational Site, Wiesbaden 65191, Germany; Completed

Pfizer Investigational Site, Athens 11527, Greece; Completed

Pfizer Investigational Site, Budapest 1134, Hungary; Recruiting

Pfizer Investigational Site, Firenze 50134, Italy; Completed

Pfizer Investigational Site, Ivrea 10015, Italy; Completed

Pfizer Investigational Site, Milano 20122, Italy; Completed

Pfizer Investigational Site, Napoli 80131, Italy; Completed

Pfizer Investigational Site, Pavia 27100, Italy; Completed

Pfizer Investigational Site, Perugia 06156, Italy; Completed

Pfizer Investigational Site, Udine 33100, Italy; Completed

Pfizer Investigational Site, Amsterdam 1105 AZ, Netherlands; Completed

Pfizer Investigational Site, Groningen 9713 GZ, Netherlands; Completed

Pfizer Investigational Site, Utrecht 3584 CX, Netherlands; Recruiting

Pfizer Investigational Site, Bucharest 011155, Romania; Completed

Pfizer Investigational Site, A Coruna 15006, Spain; Recruiting

Pfizer Investigational Site, Almeria 4009, Spain; Completed

Pfizer Investigational Site, Avila 05004, Spain; Completed

Pfizer Investigational Site, Barcelona 08035, Spain; Completed

Pfizer Investigational Site, Caceres 10003, Spain; Completed

Pfizer Investigational Site, Cadiz 11300, Spain; Completed

Pfizer Investigational Site, Granada 18012, Spain; Completed

Pfizer Investigational Site, Madrid 28046, Spain; Recruiting

Pfizer Investigational Site, Malaga 29011, Spain; Completed

Pfizer Investigational Site, Malaga 29010, Spain; Completed

Pfizer Investigational Site, Valencia 46009, Spain; Completed

Pfizer Investigational Site, Valladolid 47012, Spain; Completed

Pfizer Investigational Site, Zaragoza 50009, Spain; Completed

Pfizer Investigational Site, Goteborg 41345, Sweden; Completed

Pfizer Investigational Site, Malmo 205 02, Sweden; Completed

Pfizer Investigational Site, Stockholm 17176, Sweden; Completed

Pfizer Investigational Site, Puerto Real, Cadiz 11510, Spain; Completed

Pfizer Investigational Site, Treviso, Castelfranco Veneto 31033, Italy; Completed

Pfizer Investigational Site, Manchester, Cheshire M27 4HA, United Kingdom; Completed

Pfizer Investigational Site, Birmingham, England B4 6NH, United Kingdom; Completed

Pfizer Investigational Site, London, England NW3 2QG, United Kingdom; Completed

Pfizer Investigational Site, Palma de Mallorca, Islas Baleares 07010, Spain; Recruiting

Pfizer Investigational Site, Edinburgh, Scotland EH3 9YW, United Kingdom; Completed

Pfizer Investigational Site, Bangor, Wales LL57 2PW, United Kingdom; Completed

To obtain contact information for a study center near you, click here.

Starting date: May 2009
Last updated: January 17, 2013