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NCT07080905 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Hemophilia B, sponsored by CSL Behring.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
- 7
- Study locations
NCT07080905: Recruiting Phase 3 study of Hemophilia B, sponsored by CSL Behring.
NCT07080905 is a Phase 3 study of Hemophilia B that is actively recruiting participants, run by CSL Behring. The registered enrollment target is 20 participants, below the 96-participant average among 20 other Hemophilia B trials with a reported enrollment target (79% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07080905, a Phase 3 study of Hemophilia B, is actively recruiting participants, sponsored by CSL Behring.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a phase 3, prospective, open-label, single-arm, single-dose, multicenter study investigating the efficacy, safety, and tolerability of CSL222 (AAV5-hFIXco-Padua) in adolescent male participants with severe or moderately severe hemophilia B.
Conditions Studied
Interventions
- GENETIC CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua)
Study Locations (7)
Other
- Chaim Sheba Medical Center - Ramat Gan
- St Thomas Hospital - London
- John Radcliffe Hospital - Oxford University Hospitals NHS - Oxford
Florida
- University of Florida - Gainesville
Georgia
- Arthur M. Blank Hospital - Children's Healthcare of Atlanta - Atlanta
Michigan
- University of Michigan Medical Center - Ann Arbor
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-07-28 |
| Est. Completion | 2033-10-24 |
| Phase | Phase 3 |
What NCT07080905 shows while recruiting
NCT07080905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 96-participant average among 20 other Hemophilia B trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Hemophilia B appearing as the primary indexed condition, and to 1 intervention - of which CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua) is the first listed.
NCT07080905 lists 7 locations in 5 states (Other, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT07080905 about?
NCT07080905 is a clinical study titled "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". This is a phase 3, prospective, open-label, single-arm, single-dose, multicenter study investigating the efficacy, safety, and tolerability of CSL222 (AAV5-hFIXco-Padua) in adolescent male participants with severe or moderately severe hemophilia B.
What is the current status of trial NCT07080905?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2025-07-28. Estimated completion is 2033-10-24.
What conditions does trial NCT07080905 study?
This clinical trial studies the following conditions: Hemophilia B.
What interventions are being tested in trial NCT07080905?
The interventions under investigation include: CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua) (GENETIC).
Who is sponsoring clinical trial NCT07080905?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07080905 being conducted?
This trial has 7 study locations across Florida, Georgia, Michigan, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemophilia B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07080905's enrollment target sits among peer trials
20 16th of 20 higher than 4 of 20 other Hemophilia B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B
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Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs)
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Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
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A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
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A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors
COMPLETED · Phase 3
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