Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

NCT ID: NCT00038935

Last Updated: 2008-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2003-02-28

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.

Conditions

Hemophilia A

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

ReFacto AF

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

References

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.

Reference Type: DERIVED

PMID: 29575770 (View on PubMed)

Other Identifiers

3082B1-305

Identifier Type: -

Identifier Source: org_study_id