RecruitingPhase 3NCT07080905

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, Open-label, Single-dose, Multicenter Study Investigating Efficacy, Safety, and Tolerability of CSL222 (Etranacogene Dezaparvovec) Administered to Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B


Sponsor

CSL Behring

Enrollment

20 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 138 MonthsMax Age: 206 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua) for people with hemophilia b. The study is currently recruiting participants at 12 locations. People eligible for this study include men aged 138 Months to 206 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICCSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua)

Administered as a single IV infusion.


Locations(14)

Center for Inherited Blood Disorders

Orange, California, United States

University of Florida

Gainesville, Florida, United States

Arthur M. Blank Hospital - Children's Healthcare of Atlanta

Atlanta, Georgia, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Queensland Children's Hospital

Brisbane, Australia

Medical University Vienna

Vienna, Austria

UZ Leuven - Centrum voor Moleculaire en Vasculaire Biologie

Leuven, Belgium

CHU Hopital de la Timone

Marseille, France

Chaim Sheba Medical Center

Ramat Gan, Israel

Hospital Sant Joan de Déu

Barcelona, Spain

La Paz University Hospital

Madrid, Spain

St Thomas Hospital

London, United Kingdom

John Radcliffe Hospital - Oxford University Hospitals NHS

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07080905


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