Evaluation of Efficacy of AHCC®for the Clearance of High Risk-HPV Infections in Chinese Female: A Multi-centre, Randomised, Double Blind and Placebo-controlled Study
This is a multi-centre, randomised, double blind, placebo-controlled study on female participants with diagnosis of high-risk human papillomavirus (HR-HPV) infection to evaluate the clearance capacity of AHCC®.
• Sign the informed consent form
• Not menopausal
• Met persistent HR-HPV infection criteria:
• At least one HR-HPV positive test over 12 months prior to screening
• HR-HPV positive diagnosis by Cobas assay within 3 months prior to screening
• Low grade squamous intraepithelial lesion (LSIL) diagnosis by cytology within 6 months prior to screening
• Willing to take effective contraception method during study period.
• Negative urine pregnancy test within 7 days prior to screening
• Normal haematology, kidney and liver functions: ANC≥1,500 cells/mm3, platelets 100,000≥cells/mm3, creatinine clearance ≥60mL/min (estimated using Cockcroft Gault equation), total bilirubin, serum alanine aminotransferase (SGPT), serum aspartate aminotransferase (SGOT), and alkaline phosphatase ≤ normal value 1.5 Times.