Project Title

An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A.

Official Title

A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: Octocog Alfa) in Subjects With Hemophilia A, and a Repeat PK, Safety and Efficacy Study.

Project Summary

This is an open-label, non-randomized, efficacy, safety and pharmacokinetic (PK) study comparing octocog alfa and rVIII-SingleChain. The study consists of three parts:

1. A PK period;
2. A continuation of dosing safety and efficacy period; and
3. A safety, efficacy, and repeat PK period.

The study also includes a surgical sub-study for subjects enrolled in Parts 2 and 3.

Blood Disorder

• Hemophilia A

Patient Recruitment Details

Patient recruitment status: Closed

Number of Patients (globally)

175 participants.

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