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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-11

No results posted yet for this 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

  • Hemophilia B

Interventions

GENETIC

CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua)

Administered as a single IV infusion.

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
138 Months
Max Age
206 Months
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2033-10-24
Completion
2033-10-24
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Israel
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07080905 on ClinicalTrials.gov