Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery

A Phase IV Study of the Safety and Efficacy of ReFacto® (Moroctocog Alfa, B-Domain Deleted Recombinant Factor VIII) in Subjects With Hemophilia A Undergoing Major Surgery Monitored Using the Chromogenic Substrate Assay at the Local Laboratory

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092976

Enrollment

Registered

2004-09-29

Start date

2003-02-28

Completion date

2007-07-31

Last updated

2007-12-28

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

Conditions

Hemophilia A

Keywords

Hemophilia A

Brief summary

The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.

Interventions

DRUGReFacto

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

6 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 6 years * Male previously treated patients (≥150 Exposure Days) with moderate or severe hemophilia A (i.e. ≤ 5% FVIII:C) who will undergo elective major surgery that is anticipated to require at least 6 consecutive days of daily factor VIII (FVIII) infusions (surgical and post-surgical prophylaxis) * Ability to adhere to the protocol requirements

Exclusion criteria

* Hypersensitivity to ReFacto, murine allergen, or hamster allergen 2 History of FVIII inhibitor or current inhibitor, defined as \> 0.6 BU * Prior participation in this study * Any concomitant bleeding disorder other than hemophilia A

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and efficacy of ReFacto in subjects with Hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.	—

Secondary

Measure	Time frame
To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory	—

Countries

United States

Outcome results

None listed

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