Evaluation of AHCC® for the Clearance of High Risk-HPV Infections in Chinese Female

• Status: Recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

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®.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong University
• Collaborator: Qilu Hospital of Shandong University

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• With following medical history within 6 months prior to screening: myocardial infarction, unstable angina, heart failure, or un-controlled hypertension (>140/90 mmHg)

• Systemic treatment for HR-HPV infection has been performed within three months before screening

• Acute genital tract infection

• Previously or currently diagnosed as malignant tumour

• The cytological diagnosis is: ASC-H, AGC tends to become tumorous and other high-risk lesions

• The histological diagnosis is High grade squamous intraepithelial lesion (HSIL)

• Pregnant or breastfeeding

• A history of hepatitis (autoimmune, A, B, or C) or positive antigen

• There is a clear history of mental confusion (schizophrenia, two-way affection, psychosis) or uncontrolled epilepsy

• The main gynaecologist believes that there are significant medical complications, including immunosuppressive conditions (such as HIV, Rheumatoid arthritis, etc.) or are taking immunomodulators (such as immunosuppressive agents)

• Participants with autoimmune diseases

• Taking AHCC® capsules before screening

• Taking other immune-modulating nutritional supplements

• Planned hysterectomy (excluding subtotal hysterectomy)

• Considered by investigators as unsuitable participant of this study