Clinical trial NCT00141843: Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
Official title: A Randomized Two-Way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,Refacto AF) With a Full Length Recombinant Factor VIII Preparation (FLrFVIII,Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemophilia A
Keywords: Hemophilia A
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 100
Sex: MALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.


Eligibility criteria: Inclusion Criteria:

* Male subjects with severe or moderately severe hemophilia A
* A negative past medical history of a Factor VIII inhibitor
* Age greater than or equal to 12 years

Exclusion Criteria:

* A history of Factor VIII inhibitors
* Presence of a bleeding disorder in addition to hemophilia
* Known hypersensitivity to hamster protein

Primary outcomes:
measure: To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay.
Secondary outcomes:
measure: To characterize the efficacy of ReFActo AF in preventing and treating bleeding episodes during prophylaxis.To characterize PK of ReFacto AF as compared to Advate over time.
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Atlanta
country: United States
state: Georgia
city: Iowa City
country: United States
state: Iowa
city: New Orleans
country: United States
state: Louisiana
city: Worcester
country: United States
state: Massachusetts
city: East Lansing
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: New Brunswick
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Perth
country: Australia
city: Leuven
country: Belgium
city: Helsinki
country: Finland
city: Le Kremlin Bicêtre
country: France
city: Rouen
country: France
city: Berlin
country: Germany
city: Muenster
country: Germany
city: Budapest
country: Hungary
city: Milano
country: Italy
city: Groningen
country: Netherlands
city: Auckland
country: New Zealand
city: Hamilton
country: New Zealand
city: Lodz
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Malmö
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Germany, MedInfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, descresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Australia, New Zealand, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Sweden, Finland,MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Hungary, WPBUMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Poland, WVWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: