Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

NCT00038935

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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 < 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 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hemophilia A
Intervention  ICMJE Drug: ReFacto AF
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2003
Actual Primary Completion Date February 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00038935
Other Study ID Numbers  ICMJE 3082B1-305
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP