At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 218 enrolled
Drug / intervention
BAX855biological
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 3b Continuation Study of the Safety and Efficacy of PEGylated Recombinant Factor VIII (PEG-rFVIII; BAX 855) in Prophylaxis of Bleeding in Previously Treated Patients With Severe Hemophilia A
In Brief
A Phase 3 clinical trial evaluating BAX855 for Hemophilia A. Completed, enrolled 218 participants across 89 sites in 23 countries.
Detailed Summary
To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesAustralia, Austria, Bulgaria, Czechia, Germany, Hong Kong, Israel, Japan, Lithuania, Malaysia, Netherlands, Poland, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsBaxalta Innovations GmbH, now part of Shire
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartOct 2013
Primary CompletionMar 2018
TodayJul 2026
First PostedSep 18, 2013
Enrollment StartOct 15, 2013
Primary CompletionMar 2, 2018
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 12.8 years ago
Interventions
BAX855biological
Antihemophilic Factor (Recombinant), PEGylated