Back to resultsStudy Evaluating BDDRFVIII and ReFacto AF in Hemophilia A
Primary Purpose
Hemophilia A
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ReFacto AF
Sponsored by
About this trial
This is an interventional treatment trial for Hemophilia A focused on measuring Hemophilia
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00038935
First Posted
June 5, 2002
Last Updated
April 18, 2008
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00038935
Brief Title
Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A
Keywords
Hemophilia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ReFacto AF
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor, MD
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
29575770
Citation
Korth-Bradley J, Rupon J, Plotka A, Charnigo R, Rendo P. Assessment of Relative Bioavailability of Moroctocog Alfa and Moroctocog Alfa (AF-CC) in Subjects With Severe Hemophilia A. Clin Transl Sci. 2018 May;11(3):283-288. doi: 10.1111/cts.12544. Epub 2018 Mar 25.
Results Reference
derived
Learn more about this trial
Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A
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