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Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Phoenix, Arizona, 85016 United States
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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- A history of Factor VIII inhibitors

- Presence of a bleeding disorder in addition to hemophilia

- Known hypersensitivity to hamster protein

NCT00141843
Pfizer
Completed
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A

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Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Hemophilia A
  • Genetic: ReFacto AF
  • Genetic: B-Domain deleted Recombinant Factor VIII
  • Genetic: BDDrFVIII
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2006
November 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Finland,   France,   Germany,   Hungary,   Italy,   Netherlands,   New Zealand,   Poland,   Spain,   Sweden,   United States
 
 
NCT00141843
3082B2-310
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, [email protected]
Principal Investigator: Trial Manager For Italy, [email protected]
Principal Investigator: Trial Manager For Australia, New Zealand, [email protected]
Principal Investigator: Trial Manager For Netherlands, [email protected]
Principal Investigator: Trial Manager For Sweden, Finland,[email protected]
Principal Investigator: Trial Manager For Hungary, [email protected]
Principal Investigator: Trial Manager For Poland, [email protected]
Principal Investigator: Trial Manager For Belgium, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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