Trials / Completed
CompletedNCT02396342
Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | AAV5-hFIX | AAV5hFIX gene therapy |
Timeline
- Start date
- 2015-06-10
- Primary completion
- 2021-04-15
- Completion
- 2021-04-15
- First posted
- 2015-03-24
- Last updated
- 2022-06-27
- Results posted
- 2022-06-27
Locations
7 sites across 3 countries: Denmark, Germany, Netherlands
Source: ClinicalTrials.gov record NCT02396342. Inclusion in this directory is not an endorsement.