- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04232917
Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections. (PAPION)
Randomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Laura FERTE
- Phone Number: +32499717964
- Email: laura.ferte@labolife.com
Study Contact Backup
- Name: Charlotte BOLLE
- Email: charlotte.bolle@labolife.com
Study Locations
-
-
-
Brussels, Belgium, 1020
- Recruiting
- CHU Brugmann
-
Principal Investigator:
- Catherine Van Pachterbeke, MD
-
Sub-Investigator:
- Elie Finianos, MD
-
Contact:
- Tatiana Besse-Hammer, MD
-
Sub-Investigator:
- Tatiana Besse-Hammer, MD
-
Bruxelles, Belgium, 1000
- Recruiting
- Clinique St Jean
-
Contact:
- Nathanaël DUBOIS
-
Sub-Investigator:
- Jean-Paul VAN GOSSUM
-
Sub-Investigator:
- Justine JEHOTTE
-
Sub-Investigator:
- Andrea RADULESCU
-
Sub-Investigator:
- Mathilde BARREIRA
-
Principal Investigator:
- Nathanaël DUBOIS
-
Bruxelles, Belgium, 1050
- Recruiting
- Hôpitaux Iris Sud - Iris Zuid Ziekenhuis
-
Principal Investigator:
- Frédéric Buxant, MD
-
Sub-Investigator:
- Fiona Avau, MD
-
Contact:
- Frédéric BUXANT, MD
-
Bruxelles, Belgium, 1000
- Recruiting
- CHU Saint-Pierre
-
Contact:
- Yannick Manigart, Dr
-
Principal Investigator:
- Yannick Manigart, Dr
-
Sub-Investigator:
- Aurélie Joris, Dr
-
Sub-Investigator:
- Christine Gilles, Dr
-
Sub-Investigator:
- Charlotte Rousseau, Dr
-
Charleroi, Belgium, 6042
- Active, not recruiting
- Hôpital Civil Marie Curie ISPPC
-
Malmédy, Belgium, 4960
- Active, not recruiting
- Centre Hospital Reine Astrid Malmedy (CHRAM)
-
Namur, Belgium, 5000
- Recruiting
- Belgium
-
Contact:
- Sarah MITRI
-
Principal Investigator:
- Sarah MITRI
-
Namur, Belgium, 5000
- Recruiting
- Cabinet privé
-
Contact:
- Anne GODART
-
Principal Investigator:
- Anne Godart, Dr
-
Namur, Belgium
- Recruiting
- UCL Namur - site Sainte Elisabeth
-
Contact:
- Benoit MOONS
-
Principal Investigator:
- Benoit MOONS
-
Sub-Investigator:
- Anne GODART
-
Sub-Investigator:
- Elodie GADISSEUX
-
Sub-Investigator:
- Emmanuel BOLLUE
-
Sub-Investigator:
- Sarah MITRI
-
Sub-Investigator:
- Anne-Sophie VARZOS
-
Sub-Investigator:
- Cindy GATHY
-
Sub-Investigator:
- Amélie BOUTE
-
Namur, Belgium, 5000
- Active, not recruiting
- Belgium
-
Namur, Belgium, 5000
- Active, not recruiting
- Cabinet privé
-
Ottignies, Belgium, 1340
- Not yet recruiting
- Clinique Saint-Pierre Ottignies (CSPO)
-
Contact:
- Lucie Verreth, Dr
-
Principal Investigator:
- Lucie Verreth, Dr
-
Tournai, Belgium, 7000
- Recruiting
- CHwapi
-
Sub-Investigator:
- Céline PETIT, MD
-
Sub-Investigator:
- Sandra TASSART, MD
-
Principal Investigator:
- Marc WAYEMBERGH, MD
-
Contact:
- Marc WAYEMBERGH, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Treatment
Other Names:
|
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.
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug
Time Frame: 6 months
|
6 months
|
|
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.
|
6 months
|
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.
|
6 and 12 months
|
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.
|
6 and 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Virus Diseases
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- DNA Virus Infections
- Tumor Virus Infections
- Neoplasms, Squamous Cell
- Urogenital Diseases
- Genital Diseases
- Papillomavirus Infections
- Papilloma
Other Study ID Numbers
- LLB-2017-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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