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

• ClinicalTrials.gov Identifier: NCT04232917
• Recruitment Status: Recruiting
• First Posted: January 18, 2020
• Last Update Posted: December 22, 2022
• Sponsor: Labo'Life
• Information provided by (Responsible Party): Labo'Life

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Human Papilloma Virus	Drug: 2LPAPI®; Drug: Placebo	Phase 4

Detailed Description:

The study duration will be 24 months with 12 months of inclusion 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 284 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.
• Actual Study Start Date: October 17, 2020
• Estimated Primary Completion Date: June 15, 2024
• Estimated Study Completion Date: December 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 2LPAPI® arm; 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.	Drug: 2LPAPI®; Treatment; Other Name: 2LPAPI
Placebo Comparator: Placebo arm; 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.	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up. [ Time Frame: 12 months ]
   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.

Secondary Outcome Measures :

1. Comparison of 2LPAPI® versus placebo on HR-HPV infection clearance rate at 6-month visits. [ Time Frame: 6 months ]
   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.
2. Comparison of 2LPAPI® versus placebo on HR-HPV infection clearance rate by HPV type at 6-month and 12-month visits. [ Time Frame: 6 and 12 months ]
   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.
3. Normal cytology [ Time Frame: 6 and 12 months ]
   The objective of this outcome will be to compare the number of patients with normal cytology at 6-month and 12-month visits.
4. Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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 CIN I, and current cytology presenting ASC-US, AGUS, LSIL, ASC-H, AGC or LSIL+ASC-H or current diagnosis of CIN I at the cervical smear,
• Patient with HR-HPV diagnosis at the current cervical collection,
• Patient reporting a current stable sexual relationship (steady sexual partner during study duration),
• Patient having faculties to understand and respect the constraints of the study,
• Signature of the Informed Consent Form.

Exclusion Criteria:

• - Pregnant or breastfeeding woman,
• Patient presenting HSIL diagnosis at the cytology or CIN II or CIN III diagnosis at the cervical smear,
• Patient previously subject to total hysterectomy,
• Patient under immunotherapy (including immunosuppressive treatment) or micro-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 12 months, or likely to travel or to move before the end of the study,
• Patient with severe immunodeficiency disease requiring long term treatment (*) or under 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.

Contacts and Locations

Contacts

Contact: Danielle GERARD; 473401458 ext +32; danielle.gerard@labolife.com

Locations

Belgium

Centre Médical Le Tilleul; Withdrawn

Brussels, Belgium, 1000

CHU Brugmann; Recruiting

Brussels, Belgium, 1020

Contact: Tatiana Besse-Hammer, MD +32 (0)2 477 3312

Principal Investigator: Catherine Van Pachterbeke, MD

Sub-Investigator: Elie Finianos, MD

Clinique St Jean; Recruiting

Bruxelles, Belgium, 1000

Contact: Nathanaël DUBOIS

Sub-Investigator: Jean-Paul VAN GOSSUM

Sub-Investigator: Justine JEHOTTE

Sub-Investigator: Andrea RADULESCU

Sub-Investigator: Mathilde BARREIRA

Hôpitaux Iris Sud - Iris Zuid Ziekenhuis; Recruiting

Bruxelles, Belgium, 1050

Contact: Frédéric BUXANT, MD +32(0)26414111 fbuxant@his-izz.be

Principal Investigator: Frédéric Buxant, MD

Sub-Investigator: Fiona Avau, MD

Belgium; Recruiting

Namur, Belgium, 5000

Contact: Sarah MITRI

Principal Investigator: Sarah MITRI

Belgium; Recruiting

Namur, Belgium, 5000

Contact: Amelie BOUTE

Principal Investigator: Amelie BOUTE

Cabinet privé; Recruiting

Namur, Belgium, 5000

Contact: Emmanuel BOLLUE

Principal Investigator: Emmanuel BOLLUE

Cabinet privé; Recruiting

Namur, Belgium, 5000

Contact: Benoit MOONS

Principal Investigator: Benoit MOONS

Cabinet privé; Recruiting

Namur, Belgium, 5000

Contact: Anne GODART

Cabinet privé; Withdrawn

Namur, Belgium

Cabinet privé; Recruiting

Namur, Belgium

Contact: Anne-Sophie VARZOS

UCL Namur - site Sainte Elisabeth; Recruiting

Namur, Belgium

Contact: Benoit MOONS

Sub-Investigator: Anne GODART

Sub-Investigator: Elodie GADISSEUX

Sub-Investigator: Emmanuel BOLLUE

Principal Investigator: Benoit MOONS

Sub-Investigator: Sarah MITRI

Sub-Investigator: Anne-Sophie VARZOS

Sub-Investigator: Cindy GATHY

CHWAPI; Recruiting

Tournai, Belgium, 7000

Contact: Marc WAYEMBERGH, MD +32(0)69333111 marc.wayembergh@chwapi.be

Sub-Investigator: Celine PETIT, MD

Sub-Investigator: Sandra TASSART, MD

Principal Investigator: Marc WAYEMBERGH, MD

CHU UCL Namur - Site Godinne; Recruiting

Yvoir, Belgium, 5530

Contact: Cindy GATHY

Sponsors and Collaborators

Labo'Life

More Information

• Responsible Party: Labo'Life
• ClinicalTrials.gov Identifier: NCT04232917
• Other Study ID Numbers: LLB-2017-01
• First Posted: January 18, 2020
• Last Update Posted: December 22, 2022
• Last Verified: December 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Papillomavirus Infections; Papilloma; Infections; Neoplasms, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; DNA Virus Infections; Virus Diseases; Tumor Virus Infections