Study Evaluating ReFacto AF in Severe Hemophilia A

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00037544

Enrollment

Unknown

Registered

2002-05-20

Start date

Unknown

Completion date

2004-08-31

Last updated

2008-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Severe, Hemophilia, A

Brief summary

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

Interventions

DRUGReFacto AF

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion 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 results

Exclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026