Liver Biopsy Following Gene Therapy For Hemophilia

Exclusion Criteria

• •Any condition that, in the opinion of the investigator or sponsor of the ongoing clinical trial in which the patient is participating in, would prevent the patient from fully complying with the requirements of the clinical trial and/or would influence or interfere with evaluation and interpretation of subject safety or efficacy result of that ongoing clinical trial
• •Platelet count \<140x10\^9/L
• •INR \>1.5
• •Abnormal kidney function with estimated GFR \<50 mL/min (calculated using the CKD-EPI equation)
• •Known allergy to iodine-based intravenous contrast agents
• •Known allergy to local or general anesthetics
• •Known allergic reaction to FVIII/FIX concentrate infusions
• •Presence of FVIII inhibitor or FIX inhibitor (historical result can be used if done within 14 weeks of this liver biopsy)
• •Evidence of any bleeding disorder other than hemophilia A or B