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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 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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 96-participant average among 20 other Hemophilia B trials with a reported enrollment target (79% lower). The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 5 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.