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

Recruiting Phase 3 Interventional Study
Hemophilia B
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
138 Months – 206 Months
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
CSL Behring · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Key Inclusion Criteria for the Lead-in Period: Assigned male sex at birth * Aged ≥138 months (11 years and 6 months) to less than (\<) 206 months (17 years and 2 months) at the time of informed consent / assent. * Congenital hemophilia B with known severe or moderately sever…
Contacts

Trial Registration Coordinator

1-610-878-4697

clinicaltrials@cslbehring.com

CONTACT