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

NCT04633330 | Unknown

• 1 other identifier: AHCC-WM-0520
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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®.

Conditions

High Risk Human Papillomavirus Infection; Low Grade Squamous Intraepithelial Lesion

Keywords

HR-HPV; AHCC®

Outcome Measures

Primary Outcomes (1)

• High risk human papillomavirus (HR-HPV) infection testing, ROCHE, Cobas assay

  The Cobas human papillomavirus (HPV) test is NMPA-approved for cervical and endocervical samples collected in PreservCyt (ThinPrep) media. The Cobas HPV test detects DNA of the high-risk types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. This test does not detect DNA of HPV low-risk types (e.g., 6, 11, 42, 43, 44) since these are not associated with cervical cancer and its precursor lesions.

  6 months for all participants since enrolment

Secondary Outcomes (1)

• Interferon Beta Test-Plasma

  3 months and 6 months for all participants since enrolment, extra-6 month for responding participant from study arm, extra 3 months and 6 months for compensated participants from control arm.

Other Outcomes (1)

• Liquid based cytology test

  6 months for all participants since enrolment, extra-6 month for responding participant from study arm, and extra 6 months for compensated participants from control arm.

Study Arms (2)

Study Arm

EXPERIMENTAL

AHCC®capsules, 5 capsules \* 3 times per day, empty stomach (defined as one hour before meal or two hours after meal).

Drug: AHCC®capsules

Control Arm

PLACEBO COMPARATOR

Simulation of AHCC®capsules, 5 capsules \* 3 times per day, empty stomach (defined as one hour before meal or two hours after meal).

Drug: Simulation of AHCC®capsules

Interventions

AHCC®capsules DRUG

AHCC®capsules, a standardized extract of cultured Lentinula edodes mycelia (ECLM) TID for 6 months after enrolment.

Also known as: Yinuojin Ruanjiaonang

Study Arm

Simulation of AHCC®capsules DRUG

TID for 6 months after enrolment. A compensation of AHCC®is provided to participant from control arm when HR-HPV positive at 6 months after enrolment.

Also known as: Yinuojin Ruanjiaonang Moniji

Control Arm

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 18, 2020
• Study Start: October 26, 2020
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The sharing data will be available after Dec. 2021.

Locations

CN (1)