To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.

Official Title

An Open-label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) with Severe Hemophilia A.

Conditions

Hemophilia A

Study Type

Interventional

Study Design

Treatment

Further Details

Study Start

Eligibility & Criteria

-Ages Eligible for Study: 12 Years and above-Genders Eligible for Study: BothInclusion Criteria: * Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory) * Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product * Age greater than or equal to 12 years * History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study * Adequate laboratory resultsExclusion Criteria: * Presence of any bleeding disorder in addition to hemophilia A * Concomitant therapy with immunosuppressive drugs * Current or historical Factor VIII inhibitor * Treatment with any investigational drug or device within the past 30 days

Total Enrolment

Contact Details

Wyetg-Ayerst Research