At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
BAX 826 +1 morebiological
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 1, Prospective, Open Label, Two Period, Fixed Sequence, Dose-Escalation Study of the PK and Safety of BAX 826 (PSA-rFVIII) in Previously Treated Patients With Severe (FVIII <1%) Hemophilia A
In Brief
A Phase 1 clinical trial evaluating BAX 826 and Octocog alfa for Hemophilia A. Completed, enrolled 40 participants across 28 sites in 9 countries.
Detailed Summary
1. To assess tolerability and safety of BAX 826 after a single infusion in previously treated patients (PTPs) with severe hemophilia A 2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE 3. To evaluate immunogenicity of polysialic acid linked to Factor VIII (FVIII)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesBulgaria, Germany, Hungary, Italy, Netherlands, Poland, Russia, Spain, United Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMar 2016
First PostedMar 2016
Primary CompletionJan 2017
TodayJul 2026
First PostedMar 23, 2016
Enrollment StartMar 3, 2016
Primary CompletionJan 17, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.3 years ago
Interventions
BAX 826biological
Octocog alfabiological