At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 21 enrolled
Drug / intervention
APVO101drug
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.
Evaluation of a Recombinant Factor IX Product, APVO101, in Previously-Treated Pediatric Patients With Hemophilia B
In Brief
A Phase 3 clinical trial evaluating APVO101 for Hemophilia B. Completed, enrolled 21 participants across 11 sites in 6 countries.
Detailed Summary
Phase 3/4, single arm, open-label study to evaluate PK, safety, and efficacy of APVO101 prophylaxis in severe or moderately severe hemophilia B subjects \< 12 years of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesBrazil, Georgia, Moldova, South Africa, Turkey (Türkiye), Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartJan 2020
Primary CompletionJul 2022
TodayJul 2026
First PostedFeb 26, 2019
Enrollment StartJan 16, 2020
Primary CompletionJul 4, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.4 years ago
Interventions
APVO101drug
Subjects will receive a single IV dose of APVO101 twice weekly or at a frequency of infusions as determined appropriate by the investigator for the particular study subject for a total of 50 ED. The starting prophylaxis dose will be based on APVO101 recovery from PK Phase assessments (only pre-infusion and 15-30 minute post-infusion samples).