Clinical trial NCT00884390: Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hemophilia A
Keywords: Hemophilia A
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 208
Sex: MALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Clinically Significant Factor VIII Inhibitor Development
timeFrame: 100 exposure days to study medication (approx. 2 years)
Secondary outcomes:
measure: Annualized Bleeding Rates (ABRs)
timeFrame: 100 exposure days to study medication (approx. 2 years)
measure: Response Assessment of First On-demand Treatment of New Bleeds
timeFrame: 100 exposure days to study medication (approx. 2 years)
measure: Number of ReFacto AF Infusions to Treat Each New Bleed
timeFrame: 100 exposure days to study medication (approx. 2 years)
measure: Number of Bleeding Episodes Occurring ≤48 Hours After a Prophylaxis Infusion
timeFrame: 100 exposure days to study medication (approx. 2 years)
measure: Number of Participants With Breakthrough Bleeds
timeFrame: 100 exposure days to study medication (approx. 2 years)
measure: Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants
timeFrame: 100 exposure days to study medication (approx. 2 years)
measure: TFC Following a Prophylaxis Regimen at Baseline for All Participants
timeFrame: 100 exposure days to study medication (approx. 2 years)
measure: Average Infusion Dose
timeFrame: 100 exposure days to study medication (approx. 2 years)
measure: Incidence of Less-than-expected-therapeutic Effect (LETE) in the On-demand Setting
timeFrame: 100 exposure days to study medication (approx. 2 years)
measure: Incidence of Less-than-expected-therapeutic Effect (LETE) in the Prophylaxis Setting
timeFrame: 100 exposure days to study medication (approx. 2 years)
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Copenhagen
country: Denmark
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Chambray Les Tours Cedex
country: France
facility: Pfizer Investigational Site
city: Clermont Ferrand Cedex 1
country: France
facility: Pfizer Investigational Site
city: Clermont-Ferrand Cedex 1
country: France
facility: Pfizer Investigational Site
city: Le Chesnay
country: France
facility: Pfizer Investigational Site
city: Le Kremlin Bicetre Cedex
country: France
facility: Pfizer Investigational Site
city: Limoges Cedex 1
country: France
facility: Pfizer Investigational Site
city: Lyon Cedex 03
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 05
country: France
facility: Pfizer Investigational Site
city: Montmorency
country: France
facility: Pfizer Investigational Site
city: Montpellier Cedex 5
country: France
facility: Pfizer Investigational Site
city: Nantes
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 15
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Bremen
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt am Main
country: Germany
facility: Pfizer Investigational Site
city: Fulda
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Homburg
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Magdeburg
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Rostock
country: Germany
facility: Pfizer Investigational Site
city: Stuttgart
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Treviso
country: Italy
facility: Pfizer Investigational Site
state: Castelfranco Veneto
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Ivrea
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Udine
country: Italy
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Bucharest
country: Romania
facility: Pfizer Investigational Site
city: Puerto Real
country: Spain
facility: Pfizer Investigational Site
state: Cadiz
city: Palma de Mallorca
country: Spain
facility: Pfizer Investigational Site
state: Islas Baleares
city: A Coruna
country: Spain
facility: Pfizer Investigational Site
city: Almeria
country: Spain
facility: Pfizer Investigational Site
city: Avila
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Caceres
country: Spain
facility: Pfizer Investigational Site
city: Cadiz
country: Spain
facility: Pfizer Investigational Site
city: Granada
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Valladolid
country: Spain
facility: Pfizer Investigational Site
city: Zaragoza
country: Spain
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
state: England
city: London
country: United Kingdom
facility: Pfizer Investigational Site
state: England
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Bangor
country: United Kingdom
facility: Pfizer Investigational Site
state: Wales
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: