At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 135 enrolled
Drug / intervention
PEGylated Recombinant Factor VIII +2 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.
Phase 3, Prospective, Randomized, Multi-center Clinical Study Comparing the Safety and Efficacy of BAX 855 Following PK-guided Prophylaxis Targeting Two Different FVIII Trough Levels in Subjects With Severe Hemophilia A
In Brief
A Phase 3 clinical trial evaluating PEGylated Recombinant Factor VIII for Hemophilia A. Completed, enrolled 135 participants across 83 sites in 22 countries.
Detailed Summary
1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%) 2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesAustralia, Austria, Bulgaria, France, Germany, Hong Kong, Hungary, Israel, Italy, Malaysia, Norway, Poland, Romania, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsBaxalta Innovations GmbH, now part of Shire
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartNov 2015
Primary CompletionAug 2018
TodayJul 2026
First PostedOct 26, 2015
Enrollment StartNov 23, 2015
Primary CompletionAug 5, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.7 years ago
Interventions
PEGylated Recombinant Factor VIIIbiological
Pharmacokinetic (PK) evaluation
PEGylated Recombinant Factor VIIIbiological
Standard treatment
PEGylated Recombinant Factor VIIIbiological
Intensified treatment