Trials / Terminated
TerminatedNCT05164471
Phase 1/2 Dose Confirmation Study of FLT180a in Hemophilia B
A Dose Confirmation Study of FLT180a (Adeno-associated Viral Vector Containing the Padua Variant of a Codon-optimized Human Factor IX Gene) in Adult Subjects With Hemophilia B
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Spur Therapeutics · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Study of FLT180a gene therapy in adults with Hemophilia B. Up to 9 patients will be enrolled to receive a single dose of FLT180a and be followed for 52 weeks. Results will confirm the dose for a future Phase 3 study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | verbrinacogene setparvovec | FLT180a is a gene therapy intended to increase endogenous FIX production in adults with Hemophilia B |
Timeline
- Start date
- 2021-12-06
- Primary completion
- 2023-05-31
- Completion
- 2023-05-31
- First posted
- 2021-12-20
- Last updated
- 2023-07-20
Locations
7 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05164471. Inclusion in this directory is not an endorsement.