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Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.
Sponsor: Labo'Life
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
Conditions
Interventions
2LPAPI®
Treatment
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