Randomized, double-blind, placebo-controlled trial of orally administered bovine lactoferrin in patients with chronic hepatitis C

INTERVENTION: Lactoferrin Placebo CONDITION: Chronic hepatitis C PRIMARY OUTCOME: Virologic response, defined as a 50% or greater decrease in the serum HCV RNA level at 12 weeks compared with the baseline INCLUSION CRITERIA: 1)20‐74 years of age, 2)Positivity for anti‐HCV antibody, 3)An HCV RNA level evaluated within 1 month before entry of 0.5‐850 KIU/mL, 4)A sustained elevation of serum ALT levels (more than the upper normal limit) for at least 6 months, 5)A serum ALT level evaluated within 1 month before entry of >=twice the upper normal limit, 6)No evidence of HCC on the basis of ultrasonography or computed tomography performed within 3 months before entry, 7)Adequate bone marrow function [white blood cell count >=4000/mm3, platelet count >=100,000/mm3, and hemoglobin level >=11 g/dL], liver function [total bilirubin level <=2.0 mg/dL, serum albumin level >=3.5 g/dL, and serum AST and ALT levels <=200 IU/L], and renal function [normal serum creatinine and blood urea nitrogen levels], 8)Written informed consent