CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
ReFacto AFbiological
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Male, at least 12 years old
  • ✓Severe hemophilia A
  • ✓Undergoing elective major surgery requiring FVIII replacement for at least 6 days
  • ✓Negative FVIII inhibitor test at screening
Key exclusion· 2
  • ✕Normal hepatic and renal function tests required (exclusion of abnormal function)
  • ✕No other bleeding disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00243659
NCT00243659Phase 3Completed
CompareCT.gov

An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Oct 24, 2005·Updated Jun 3, 2011

In Brief

A Phase 3 clinical trial evaluating ReFacto AF for Hemophilia A. Completed, enrolled 30 participants across 17 sites in 8 countries.

Detailed Summary

This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesAustralia, Austria, Hungary, New Zealand, Poland, Romania, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 24, 2005
Enrollment StartApr 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 20.7 years ago

Interventions

ReFacto AFbiological