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Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Washington, District of Columbia, 20007 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
18-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Severe hemophilia A

- Previously treated patients with at least 150 exposure days to any Factor VIII product

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Hypersensitivity to any recombinant Factor VIII product

- History of or current Factor VIII inhibitor

- Bleeding episode or other reason requiring Factor VIII treatment within 3 days of
study

NCT00168051
Pfizer
Completed
Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

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Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A
A Single Dose, Randomized, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of ReFacto (B-domain Deleted Recombinant Human Factor VIII (BDDrFVIII) and Advante (a Full-length Recombinant Factor VIII (FLrFVIII)
The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Hemophilia A
  • Drug: ReFacto
  • Drug: Advante
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
21
November 2005
November 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Severe hemophilia A
  • Previously treated patients with at least 150 exposure days to any Factor VIII product

Exclusion Criteria:

  • Hypersensitivity to any recombinant Factor VIII product
  • History of or current Factor VIII inhibitor
  • Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study
Sexes Eligible for Study: Male
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Italy,   Netherlands,   New Zealand,   United Kingdom,   United States
 
 
NCT00168051
3082A-101711/3082A1-900
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
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 Belgium, [email protected]
Principal Investigator: Trial Manager For Netherlands, [email protected]
Principal Investigator: Trial Manager For New Zealand, [email protected]
Principal Investigator: Trial Manager For UK, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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