Study of a Gene Therapy Treatment for Hemophilia A
Public ClinicalTrials.gov record NCT06297486. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06297486
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 13, 2024 (Actual)
- Primary completion
- May 2027 (Estimated)
- Completion
- Sep 4, 2035 (Estimated)
- Last update posted
- Dec 13, 2024
2024 – 2035
United States locations
- U.S. sites
- 27
- U.S. states
- 14
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Loma Linda University Health | Loma Linda | California | 92354 | — |
| Orthopaedic Institute for Children/Orthopaedic Hemophilia Treatment Center | Los Angeles | California | 90007 | — |
| Kaiser Permanente-Oakland Medical Center | Oakland | California | 94611 | — |
| Kaiser Permanente-Roseville Medical Center | Roseville | California | 95661 | — |
| Kaiser Permanente -Sacramento Medical Center | Sacramento | California | 95814 | — |
| Kaiser Permanente -San Francisco Medical Center | San Francisco | California | 94115 | — |
| University of California - San Francisco | San Francisco | California | 94143 | — |
| Kaiser Permanente- Santa Clara Medical Center | Santa Clara | California | 94115 | — |
| Kaiser Permanente-Vallejo Medical Center | Vallejo | California | 94589 | — |
| Kaiser Permanente -Walnut Creek Medical Center | Walnut Creek | California | 94596 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Newark Beth Israel | Newark | New Jersey | 07112 | — |
| Weill Cornell Medical Hospital | New York | New York | 10065 | — |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| University Hospitals Cleveland | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Oregon Health & Sciences University | Portland | Oregon | 97239 | — |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19103 | — |
| Cook Children's Hospital | Fort Worth | Texas | 76104 | — |
| The University of Texas Health Science Center at Houston-Gulf States Hemophilia & Thrombosis Center | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| Bloodworks NW | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06297486, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 13, 2024 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06297486 live on ClinicalTrials.gov.