Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04232917
PHASE4

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

Sponsor: Labo'Life

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

25 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

284

Start Date

2020-10-17

Completion Date

2027-10-30

Last Updated

2024-10-31

Healthy Volunteers

No

Interventions

DRUG

2LPAPI®

Treatment

DRUG

Placebo

Placebo

Locations (12)

CHU Saint-Pierre

Brussels, Belgium

Clinique St Jean

Brussels, Belgium

CHU Brugmann

Brussels, Belgium

Hôpitaux Iris Sud - Iris Zuid Ziekenhuis

Brussels, Belgium

Hôpital Civil Marie Curie ISPPC

Charleroi, Belgium

Centre Hospital Reine Astrid Malmedy (CHRAM)

Malmedy, Belgium

Belgium

Namur, Belgium

Belgium

Namur, Belgium

Cabinet privé

Namur, Belgium

UCL Namur - site Sainte Elisabeth

Namur, Belgium

Clinique Saint-Pierre Ottignies (CSPO)

Ottignies, Belgium

CHWAPI

Tournai, Belgium