Last reviewed · How we verify
NCT07080905: IX-TEND 3004
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
Phase 3 trial testing CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua) in Hemophilia B in 20 participants. Currently enrolling.
24 October 2033
Quick facts
| Lead sponsor | CSL Behring |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 28 July 2025 |
| Primary completion | 24 October 2033 |
| Estimated completion | 24 October 2033 |
| Sites | 10 locations across Belgium, Austria, United Kingdom, Israel, United States |
Drugs / interventions tested
- CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua)
Conditions studied
- Hemophilia B — all drugs for Hemophilia B →
Sponsor
CSL Behring — full company profile →
Who can join
Adults 138 Months to 206 Months, male only, with Hemophilia B. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07080905
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hemophilia B
Currently open trials in the same condition.
- NCT06727669 — Longitudinal Cohort of Thrombosis and Hemostasis Diseases · recruiting
- NCT06565481 — Measurement Properties in People with Hemophilia · NA · recruiting
- NCT06379789 — A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) · Phase 1, PHASE2 · recruiting
- NCT06399289 — Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Pre · Phase 3 · active not recruiting
- NCT06349473 — A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Hea · Phase 1 · recruiting
Other CSL Behring trials
Trials by the same sponsor.
- NCT07326592 — Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza · Phase 4 · not yet recruiting
- NCT07224360 — Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD) · Phase 2 · recruiting
- NCT07332091 — Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary He · Phase 2 · recruiting
- NCT07094087 — Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovasc · Phase 3 · recruiting
- NCT07048262 — Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NC · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07080905 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CSL Behring
- Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07080905.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing