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

Primary Purpose

Human Papilloma Virus

Status

Recruiting

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

2LPAPI®

Placebo

About this trial

This is an interventional treatment trial for Human Papilloma Virus

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

2LPAPI® arm

Placebo arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up.

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

Comparison of 2LPAPI® versus placebo on HR-HPV infection clearance rate at 6-month visits.

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.

Comparison of 2LPAPI® versus placebo on HR-HPV infection clearance rate by HPV type at 6-month and 12-month visits.

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.

Normal cytology

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

Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug

Full Information

NCT ID

NCT04232917

First Posted

January 14, 2020

Last Updated

October 6, 2023

Sponsor

Labo'Life

1. Study Identification

Unique Protocol Identification Number

NCT04232917

Brief Title

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

Acronym

PAPION

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 17, 2020 (Actual)

Primary Completion Date

June 15, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Labo'Life

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Papilloma Virus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

284 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

2LPAPI® arm

Arm Type

Experimental

Arm Description

Arm Title

Placebo arm

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

2LPAPI®

Other Intervention Name(s)

2LPAPI

Intervention Description

Treatment

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up.

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Comparison of 2LPAPI® versus placebo on HR-HPV infection clearance rate at 6-month visits.

Description

Time Frame

6 months

Title

Comparison of 2LPAPI® versus placebo on HR-HPV infection clearance rate by HPV type at 6-month and 12-month visits.

Description

Time Frame

6 and 12 months

Title

Normal cytology

Description

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

Time Frame

6 and 12 months

Title

Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laura FERTE

Phone

+32499717964

laura.ferte@labolife.com

First Name & Middle Initial & Last Name or Official Title & Degree

Charlotte BOLLE

charlotte.bolle@labolife.com

Facility Information:

Facility Name

CHU Brugmann

City

Brussels

ZIP/Postal Code

1020

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tatiana Besse-Hammer, MD

First Name & Middle Initial & Last Name & Degree

Catherine Van Pachterbeke, MD

First Name & Middle Initial & Last Name & Degree

Elie Finianos, MD

First Name & Middle Initial & Last Name & Degree

Tatiana Besse-Hammer, MD

Facility Name

CHU Saint-Pierre

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yannick Manigart, Dr

First Name & Middle Initial & Last Name & Degree

Yannick Manigart, Dr

First Name & Middle Initial & Last Name & Degree

Aurélie Joris, Dr

First Name & Middle Initial & Last Name & Degree

Christine Gilles, Dr

First Name & Middle Initial & Last Name & Degree

Charlotte Rousseau, Dr

Facility Name

Clinique St Jean

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nathanaël DUBOIS

First Name & Middle Initial & Last Name & Degree

Jean-Paul VAN GOSSUM

First Name & Middle Initial & Last Name & Degree

Justine JEHOTTE

First Name & Middle Initial & Last Name & Degree

Andrea RADULESCU

First Name & Middle Initial & Last Name & Degree

Mathilde BARREIRA

First Name & Middle Initial & Last Name & Degree

Nathanaël DUBOIS

Facility Name

Hôpitaux Iris Sud - Iris Zuid Ziekenhuis

City

Bruxelles

ZIP/Postal Code

1050

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frédéric BUXANT, MD

First Name & Middle Initial & Last Name & Degree

Frédéric Buxant, MD

First Name & Middle Initial & Last Name & Degree

Fiona Avau, MD

Facility Name

Hôpital Civil Marie Curie ISPPC

City

Charleroi

ZIP/Postal Code

6042

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Centre Hospital Reine Astrid Malmedy (CHRAM)

City

Malmédy

ZIP/Postal Code

4960

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Belgium

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah MITRI

First Name & Middle Initial & Last Name & Degree

Sarah MITRI

Facility Name

Belgium

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Cabinet privé

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Individual Site Status

Active, not recruiting

Facility Name

Cabinet privé

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne-Sophie VARZOS

First Name & Middle Initial & Last Name & Degree

Anne-Sophie VARZOS

Facility Name

Cabinet privé

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benoit MOONS

First Name & Middle Initial & Last Name & Degree

Benoit MOONS

Facility Name

Cabinet privé

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne GODART

First Name & Middle Initial & Last Name & Degree

Anne Godart, Dr

Facility Name

UCL Namur - site Sainte Elisabeth

City

Namur

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benoit MOONS

First Name & Middle Initial & Last Name & Degree

Anne GODART

First Name & Middle Initial & Last Name & Degree

Elodie GADISSEUX

First Name & Middle Initial & Last Name & Degree

Emmanuel BOLLUE

First Name & Middle Initial & Last Name & Degree

Benoit MOONS

First Name & Middle Initial & Last Name & Degree

Sarah MITRI

First Name & Middle Initial & Last Name & Degree

Anne-Sophie VARZOS

First Name & Middle Initial & Last Name & Degree

Cindy GATHY

First Name & Middle Initial & Last Name & Degree

Amélie BOUTE

Facility Name

Clinique Saint-Pierre Ottignies (CSPO)

City

Ottignies

ZIP/Postal Code

1340

Country

Belgium

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lucie Verreth, Dr

First Name & Middle Initial & Last Name & Degree

Lucie Verreth, Dr

Facility Name

CHWAPI

City

Tournai

ZIP/Postal Code

7000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc WAYEMBERGH, MD

First Name & Middle Initial & Last Name & Degree

Céline PETIT, MD

First Name & Middle Initial & Last Name & Degree

Sandra TASSART, MD

First Name & Middle Initial & Last Name & Degree

Marc WAYEMBERGH, MD

12. IPD Sharing Statement

Learn more about this trial

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

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

Human Papilloma Virus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial