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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
NCT07080905 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07080905
The ClinicalTrials.gov registry entry for NCT07080905 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07080905 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Other, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07080905?
The interventions under investigation include: CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua) (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07080905?
This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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