At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 16 enrolled
Drug / intervention
Advate (Low Dose) +3 morebiological
Likely dose
Advate (Low Dose) 25 IUfrom 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 1/2a, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN (BIVV001) in Previously Treated Adults With Severe Hemophilia A
In Brief
A Phase 2 clinical trial evaluating Advate (Low Dose), Advate (High Dose), and 2 other interventions for Hemophilia A. Completed, enrolled 16 participants across 10 sites in 2 countries.
Detailed Summary
The primary purpose was to assess the safety and tolerability of a single intravenous (IV) administration of BIVV001 in adult previously treated patients (PTPs) with severe hemophilia A.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesJapan, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartAug 2017
Primary CompletionNov 2018
TodayJul 2026
First PostedJul 2, 2017
Enrollment StartAug 28, 2017
Primary CompletionNov 12, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9 years ago
Interventions
Advate (Low Dose)biological
Participants received a single IV low dose of Advate 25 IU/kg.
Advate (High Dose)biological
Participants received a single IV high dose of Advate 65 IU/kg.
BIVV001 (Low Dose)biological
Participants received single IV low dose of BIVV001 25 IU/kg.
BIVV001 (High Dose)biological
Participants received single IV high dose of BIVV001 65 IU/kg.