NCT04232917

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

Randomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Labo'Life · Industry
• Sex: Female
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Human Papilloma Virus

Interventions

Type	Name	Description
DRUG	2LPAPI®	Treatment
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-10-17
• Primary completion: 2027-03-15
• Completion: 2027-10-30
• First posted: 2020-01-18
• Last updated: 2024-10-31

Locations

12 sites across 1 country: Belgium