Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

A Single Dose, Randomized, Double-Blind, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII) Manufactured by the Current Process (ReFacto) and by an Albumin Free Manufacturing Process (ReFacto AF)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00038935

Enrollment

Unknown

Registered

2002-06-07

Start date

Unknown

Completion date

2003-02-28

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

Hemophilia

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.

Interventions

DRUGReFacto AF

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Outcome results

None listed

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