Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

Phase 3 Completed Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start: —
Primary completion: 2003-02
Completion: 2003-02

Outcome

Met primary endpoint

paper The bioequivalence criteria were met. PMID 29575770 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Moroctocog alfa	Protein / enzyme biologic	—	—