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Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Females and Males
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

- Severe hemophilia A (FVIII:C

- Previously treated patients (PTP) with at least 250 exposure days to any factor VIII
product

- 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

- The presence of any bleeding disorder in addition to hemophilia A

- Concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin
(IVIG), routine systemic corticosteroid use)

- History of detectable factor VIII inhibitor

NCT00038935
Pfizer
Completed
Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

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Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A
A Single Dose, Randomized, Double-Blind, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII) Manufactured by the Current Process (ReFacto) and by an Albumin Free Manufacturing Process (ReFacto AF)
The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Hemophilia A
Drug: ReFacto AF
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
Not Provided
February 2003
February 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Severe hemophilia A (FVIII:C < 1% at local laboratory)
  • Previously treated patients (PTP) with at least 250 exposure days to any factor VIII product
  • Age greater than or equal to 12 years\

Exclusion Criteria:

  • The presence of any bleeding disorder in addition to hemophilia A
  • Concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin (IVIG), routine systemic corticosteroid use)
  • History of detectable factor VIII inhibitor
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00038935
3082B1-305
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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