Infections

All Conditions

Neoplasms

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Papilloma

Communicable Diseases

Virus Diseases

Papillomavirus Infections

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.

2LPAPI®

Placebo

Laura FERTE

Charlotte BOLLE

Tatiana Besse-Hammer, MD

Catherine Van Pachterbeke, MD

Elie Finianos, MD

Yannick Manigart, Dr

Aurélie Joris, Dr

Christine Gilles, Dr

Charlotte Rousseau, Dr

Nathanaël DUBOIS

Jean-Paul VAN GOSSUM

Justine JEHOTTE

Andrea RADULESCU

Mathilde BARREIRA

Frédéric BUXANT, MD

Frédéric Buxant, MD

Fiona Avau, MD

Sarah MITRI

Anne-Sophie VARZOS

Benoit MOONS

Anne GODART

Anne Godart, Dr

Elodie GADISSEUX

Emmanuel BOLLUE

Cindy GATHY

Amélie BOUTE

Lucie Verreth, Dr

Marc WAYEMBERGH, MD

Céline PETIT, MD

Sandra TASSART, MD

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.

The study duration will be 48 months with 36 months of inclusion (that may be extended if the expected number of patients is not reached after 36 months) and 12 months of follow-up.

Patients aged between 25 and 45 years who present cervical abnormalities 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,
* Normal cytology,
* Safety.

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.

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.

The primary objective of the study will be to compare the number of patients with positive HR-HPV infection status observed at 12 months and the number of patients with positive HR-HPV infection status observed at the inclusion.

The objective of this outcome will be to compare the number of patients with positive HR-HPV infection status observed at 6 months and the number of patients with positive HR-HPV infection status observed at the inclusion.

The objective of this outcome will be to compare the number of patients with specific type of HPV infection observed at 6 and 12 months and the number of patients with specific HPV infection status observed at the inclusion.

The objective of this outcome will be to compare the number of patients with normal cytology at 6-month and 12-month visits.

Labo'Life

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.	NCT04232917	Human Papilloma...	2LPAPI® Placebo	25 Years - 45 Years	Labo'Life
Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.	NCT04232917	Human Papilloma...	2LPAPI® Placebo	25 Years - 45 Years	Labo'Life

Spots Global Cancer Trial Database for 2lpapi®

Every month we try and update this database with for 2lpapi® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 2lpapi®

Every month we try and update this database with for 2lpapi® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 2lpapi® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.