At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
AAV5-hFIXgenetic
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 I/II, Open-label, Uncontrolled, Single-dose, Dose-ascending, Multi-centre Trial Investigating an Adeno-associated Viral Vector Containing a Codon-optimized Human Factor IX Gene (AAV5-hFIX) Administered to Adult Patients With Severe or Moderately Severe Hemophilia B
In Brief
A Phase 2 clinical trial evaluating AAV5-hFIX for Hemophilia B. Completed, enrolled 10 participants across 7 sites in 3 countries.
Detailed Summary
This study evaluates how safe gene therapy treatment with AAV5-hFIX is in adult patients with severe or moderately severe hemophilia B and severe bleeding type.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesDenmark, Germany, Netherlands
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartJun 2015
Primary CompletionApr 2021
TodayJul 2026
First PostedMar 24, 2015
Enrollment StartJun 10, 2015
Primary CompletionApr 15, 2021
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 11.3 years ago
Interventions
AAV5-hFIXgenetic
AAV5hFIX gene therapy