Phase 1/2 Dose Confirmation Study of FLT180a in Hemophilia B
NCT05164471 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2023-07-20
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
- Hemophilia B
Interventions
- GENETIC
-
verbrinacogene setparvovec
FLT180a is a gene therapy intended to increase endogenous FIX production in adults with Hemophilia B
Sponsors & Collaborators
-
Spur Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-06
- Primary Completion
- 2023-05-31
- Completion
- 2023-05-31
- FDA Drug
- Yes
Countries
- United States
- United Kingdom
Study Locations
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