At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 30 enrolled
Drug / intervention
PEGylated Recombinant factor VIII (rFVIII)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multi-Center, Open Label Study of Efficacy and Safety of PEGylated rFVIII (BAX 855) in Previously Treated Patients With Severe Hemophilia A Undergoing Surgical or Other Invasive Procedures
In Brief
A Phase 3 clinical trial evaluating PEGylated Recombinant factor VIII (rFVIII) for Hemophilia A. Completed, enrolled 30 participants across 22 sites in 9 countries.
Detailed Summary
The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing elective surgical or other invasive procedures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesBulgaria, Lithuania, Netherlands, Russia, Spain, Switzerland, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartDec 2013
Primary CompletionSep 2016
TodayJul 2026
First PostedAug 1, 2013
Enrollment StartDec 20, 2013
Primary CompletionSep 23, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.9 years ago
Interventions
PEGylated Recombinant factor VIII (rFVIII)biological
Lyophilized powder and solvent for solution for injection