Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery

Wyeth

Status and phase: Completed; Phase 4

Conditions: Hemophilia A

Treatments: Drug: ReFacto

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092976

3082A2-401

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: Male

Ages: 6+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)