Trials / Withdrawn
WithdrawnNCT06297486
Study of a Gene Therapy Treatment for Hemophilia A
A Phase 3, Single-arm, Open-label, Multicenter Study of the Safety and Efficacy of Dirloctocogene Samoparvovec (SPK 8011, Adeno-associated Viral Vector With B-domain Deleted Human Factor VIII Gene) in Adults With Severe or Moderately Severe Hemophilia A
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Spark Therapeutics, Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy of SPK-8011 in preventing bleed episodes compared with FVIII prophylaxis in participants with hemophilia A without FVIII inhibitors on routine FVIII prophylaxis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | SPK-8011 | Participants will receive a single dose of SPK-8011, administered by intravenous (IV) infusion, on Day 1. |
Timeline
- Start date
- 2024-03-13
- Primary completion
- 2027-05-01
- Completion
- 2035-09-04
- First posted
- 2024-03-07
- Last updated
- 2024-12-13
Locations
27 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06297486. Inclusion in this directory is not an endorsement.