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

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ClinicalTrials.gov Identifier: NCT04232917
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Labo'Life

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.

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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 : October 17, 2021
Estimated Study Completion Date : December 1, 2022

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




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 ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232917


Contacts
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Contact: Astrid GARREAU 6 59 11 39 29 astrid.garreau@labolife.com
Contact: Aurore MABOGE +32 472 90 51 06 aurore.maboge@labolife.com

Locations
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Belgium
Centre Médical Le Tilleul Not yet recruiting
Brussels, Belgium, 1000
Contact: Nathanaël DUBOIS         
Cabinet privé Recruiting
Namur, Belgium
Contact: Philippe Goffin         
Sub-Investigator: Anne Godard         
Cabinet privé Recruiting
Namur, Belgium
Contact: Emmanuel BOLLUE         
Sub-Investigator: Sarah MITRI         
Sub-Investigator: Benoit MOONS         
Sub-Investigator: Amélie BOUTE         
Cabinet privé Not yet recruiting
Namur, Belgium
Contact: Elodie GADISSEUX         
Cabinet privé Not yet recruiting
Namur, Belgium
Contact: Nicolas ROYER         
Cabinet privé Not yet recruiting
Namur, Belgium
Contact: Anne-Sophie VARZOS         
UCL Namur - site Sainte Elisabeth Recruiting
Namur, Belgium
Contact: Phillipe GOFFIN         
CHU UCL Namur - Site Godinne Not yet recruiting
Yvoir, Belgium, 5530
Contact: Cindy GATHY         
Sponsors and Collaborators
Labo'Life
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Responsible Party: Labo'Life
ClinicalTrials.gov Identifier: NCT04232917    
Other Study ID Numbers: LLB-2017-01
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Papillomavirus Infections
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
DNA Virus Infections
Virus Diseases
Tumor Virus Infections