Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.

Last updated: October 29, 2024
Sponsor: Labo'Life
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

2LPAPI®

Placebo

Clinical Study ID

NCT04232917
LLB-2017-01
  • Ages 25-45
  • Female

Study Summary

Human papillomavirus (HPV) is a prevalent pathogen, the epidemiology of which has mostly been studied in the uterine cervix and the vagina.

The KCE Report 238Cs (2015) recommends " HR-HPV-positive women should not be offered colposcopy immediately. Triage should be done using cytology for this purpose. If cytological abnormalities (ASCUS+) are found, immediate referral should follow for diagnosis and, where appropriate, treatment. If no abnormalities are observed in triage, the subject should be offered follow-up testing (cytology) at six months. ".

There is no treatment that is recommended during this lap time. The 2LPAPI® has been available for more than 20 years, and has received a marketing authorization in Belgium by the FAMHP. It is used as an immune regulator in the treatment of HR-HPV infections. Since 2LPAPI® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the clearance of HPV.

The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LPAPI® on the clearance of genital HR-HPV infections.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women 25-45 years,

  • Women of childbearing age under effective contraception,

  • Patient with last cytology less than 3 years and normal or not more than LSIL or CINI at the histology,

  • Patient with current cytology presenting normal, ASC-US, AGUS, LSIL, ASC-H, AGC orLSIL+ASC-H results or current diagnosis of CIN I at the histology,

  • Patient with HR-HPV diagnosis at the current cervical collection,

  • Patient reporting a current stable sexual relationship (steady sexual partner duringstudy duration),

  • Patient having faculties to understand and respect the constraints of the study,

  • Signature of the Informed Consent Form.

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding woman,

  • Patient presenting HSIL diagnosis at the cytology or CIN II or CIN III diagnosis atthe histology,

  • Patient having received HPV vaccination in the last month,

  • Patient previously subject to total hysterectomy,

  • Patient under immunotherapy (including immunosuppressive treatment) ormicro-immunotherapy received during last previous 6 months,

  • Patient with known lactose intolerance,

  • Patient who participated in a clinical study in the previous 3-months' period,

  • Patient who is not sufficiently motivated to engage in a follow-up period of 12months, or likely to travel or to move before the end of the study,

  • Patient with severe immunodeficiency disease requiring long term treatment (*) orunder chemotherapy or radiotherapy,

  • Patient under listed homeopathic or phytotherapy treatment (see protocol),

  • Patient using or addicted to recreational drugs.

(*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.

Study Design

Total Participants: 284
Treatment Group(s): 2
Primary Treatment: 2LPAPI®
Phase: 4
Study Start date:
October 17, 2020
Estimated Completion Date:
October 30, 2027

Study Description

The study duration will be 72 months with 60 months of inclusion (that may be extended if the expected number of patients is not reached after 60 months) and 12 months of follow-up.

Patients aged between 25 and 45 years presenting a diagnosis of HR-HPV infection during the routine screening visit for cervical cancer prevention.

The total number of patients to include will be 284 with 142 patients per group.

Primary objective:

Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up.

Secondary objectives:

Comparison of 2LPAPI® versus placebo on:

  • HR-HPV infection clearance rate at 6-month visits,

  • HR-HPV infection clearance rate by HPV type at 6-month and 12-month visits,

  • Evolution of cytology,

  • Normalization of cytology for the subpopulation of patients with a baseline non normal cytology,

  • Safety: adverse events (AEs) and serious adverse events (SAEs), considered as related or not to the study drug.

Treatment phase:

Group n°1 = 2LPAPI® (6 months of treatment) Group n°2 = Placebo (6 months of treatment) Post-treatment follow-up phase: 6 months. Treatment will be considered successful if the clearance of HR-HPV is done and the cytology is normal.

Connect with a study center

  • CHIREC - Braine l'Alleud

    Braine-l'Alleud, 1420
    Belgium

    Site Not Available

  • CHU Brugmann

    Brussels, 1020
    Belgium

    Active - Recruiting

  • Centre Médical Le Tilleul

    Brussels, 1000
    Belgium

    Site Not Available

  • Avenue Brugmann, 406

    Bruxelles, 1180
    Belgium

    Site Not Available

  • CHU Saint-Pierre

    Bruxelles, 1000
    Belgium

    Active - Recruiting

  • Clinique St Jean

    Bruxelles, 1000
    Belgium

    Active - Recruiting

  • Hôpitaux Iris Sud - Iris Zuid Ziekenhuis

    Bruxelles, 1050
    Belgium

    Active - Recruiting

  • Hôpital Civil Marie Curie ISPPC

    Charleroi, 6042
    Belgium

    Site Not Available

  • Centre Hospital Reine Astrid Malmedy (CHRAM)

    Malmédy, 4960
    Belgium

    Site Not Available

  • Belgium

    Namur, 5000
    Belgium

    Active - Recruiting

  • Cabinet privé

    Namur, 5000
    Belgium

    Active - Recruiting

  • UCL Namur - site Sainte Elisabeth

    Namur,
    Belgium

    Active - Recruiting

  • Clinique Saint-Pierre Ottignies (CSPO)

    Ottignies, 1340
    Belgium

    Site Not Available

  • CHWAPI

    Tournai, 7000
    Belgium

    Active - Recruiting

  • CHU UCL Namur - Site Godinne

    Yvoir, 5530
    Belgium

    Site Not Available

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