Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B
Public ClinicalTrials.gov record NCT07080905. 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
Phase 3, Open-label, Single-dose, Multicenter Study Investigating Efficacy, Safety, and Tolerability of CSL222 (Etranacogene Dezaparvovec) Administered to Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B
Study identification
- NCT ID
- NCT07080905
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- CSL Behring
- Industry
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Interventions
- CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua) Genetic
Genetic
Eligibility (public fields only)
- Age range
- 138 Months to 206 Months
- Sex
- Male
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 27, 2025
- Primary completion
- Oct 23, 2033
- Completion
- Oct 23, 2033
- Last update posted
- Apr 15, 2026
2025 – 2033
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Center for Inherited Blood Disorders | Orange | California | 92868 | Recruiting |
| University of Florida | Gainesville | Florida | 32611 | Recruiting |
| Arthur M. Blank Hospital - Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | Recruiting |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | Recruiting |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07080905, 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 Apr 15, 2026 · Synced Apr 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07080905 live on ClinicalTrials.gov.