← Issue №12/ week of Sep 20, 2026/Hepatology

Factor IX Padua AAV gene therapy in adolescents with hemophilia B: a phase 1 trial.

From GI Signals issue №12: what this paper found, what it changes, and where it sits against the current standard of care, reviewed by Simon Mathews, MD.

Hepatology rct · n=11 · Sep 16, 2026 · Nature Medicine · IF 52.5

Factor IX Padua AAV gene therapy in adolescents with hemophilia B: a phase 1 trial.

New evidencepediatricbiomarkertranslationalbasic science
Clinical takeawayConsider BBM-H901 gene therapy for adolescents with severe or moderately severe hemophilia B (FIX:C ≤2 IU/dl) in clinical trials, monitoring for adverse events such as liver enzyme elevation and corticosteroid-associated rash.
What it foundAAV gene therapy BBM-H901 in adolescents with hemophilia B (FIX:C ≤2 IU/dl) increased mean FIX:C to 41.8 IU/dl at 52 weeks and reduced annualized bleeding rate from 13.9 to 0.5, with observed adverse events including elevated liver enzymes, white blood cell count, and rash.
ContextExtends prior adult data on AAV gene therapy for hemophilia B to adolescents, showing similar efficacy and safety, but with notable adverse events requiring careful monitoring.
No standard claimed for this paper

Every paper is compared to the standard governing its question. This one is not: either no standard in the corpus matches it, or the comparison did not hold up on review and was withdrawn rather than published unverified. Both are logged.

Xue F … Zhang L · Nature Medicine · IF 52.5 · PubMed ↗Permalink
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