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NCT05962398: IX-TEND 3003
Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)
trial testing AAV5-hFIXco-Padua in Hemophilia B in 56 participants. Enrolling by invitation.
23 March 2035
Quick facts
| Lead sponsor | CSL Behring |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 56 |
| Start date | 30 August 2023 |
| Primary completion | 23 March 2035 |
| Estimated completion | 23 March 2035 |
| Sites | 28 locations across Denmark, Netherlands, Belgium, Sweden, Ireland, United Kingdom, Germany, United States |
Drugs / interventions tested
- AAV5-hFIXco-Padua
Conditions studied
- Hemophilia B — all drugs for Hemophilia B →
Sponsor
CSL Behring — full company profile →
Who can join
18 and older, male only, with Hemophilia B. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary purpose of this study is to assess the long-term safety and efficacy in male adults with hemophilia B who were treated with CSL222 (CSL222) in parent studies CSL222\_2001 (NCT03489291) or CSL222\_3001 (NCT03569891).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Completion of phase 2b trial of etranacogene dezaparvovec gene therapy in patients with hemophilia B over 5 years.
von Drygalski A, Gomez E, Giermasz A, Castaman G, et al · · 2025 · cited 6× · PMID 40188458 · DOI 10.1182/bloodadvances.2024015291
Verify or expand the search:
- PubMed search for NCT05962398
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AAV5-hFIXco-Padua
Trials testing the same drug.
- NCT03569891 — HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients · Phase 3 · completed
Other recruiting trials for Hemophilia B
Currently open trials in the same condition.
- NCT07080905 — Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or · Phase 3 · recruiting
- 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
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 NCT05962398 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 18 July 2025
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/NCT05962398.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing