Human Papilloma VirusPhase 4PAPIONNCT04232917
Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.
A Phase 4 study testing 2LPAPI® in people with Human Papilloma Virus, run by Labo'Life at 11 sites in 2 countries.
Trial summary
Human papillomavirus (HPV) is a prevalent pathogen, the epidemiology of which has mostly been studied in the uterine cervix and the vagina. In Belgium, since 2025, HPV testing has become the primary screening method for cervical cancer. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- 2LPAPI®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 17 Oct 2020to 30 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 LSIL or CIN I at the histology,
- Patient with current cytology presenting normal, ASC-US, AGUS, LSIL, ASC-H, AGC or LSIL+ASC-H results or current diagnosis of CIN I at the histology,
- 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.
Who cannot join
- Pregnant or breastfeeding woman,
- Patient presenting HSIL diagnosis at the cytology or CIN II or CIN III diagnosis at the histology,
- Patient having received HPV vaccination in the last month,
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Charlotte BOLLE contact
11 sites in 2 countries
Belgium10 sites, 8 recruiting
- Recruiting
CHU Saint-Pierre
Brussels, 1000
Yannick Manigart, Dr
Yannick Manigart, Dr
- Recruiting
Clinique St Jean
Brussels, 1000
Nathanaël DUBOIS
Jean-Paul VAN GOSSUM
- Recruiting
CHU Brugmann
Brussels, 1020
Tatiana Besse-Hammer, MD
Catherine Van Pachterbeke, MD
- Active, not recruiting
Hôpital Civil Marie Curie ISPPC
Charleroi, 6042
- Active, not recruiting
Centre Hospital Reine Astrid Malmedy (CHRAM)
Malmedy, 4960
- Recruiting
Belgium
Namur, 5000
Sarah MITRI
Sarah MITRI
- Recruiting
Cabinet privé
Namur, 5000
Benoit MOONS
Benoit MOONS
- Recruiting
UCL Namur - site Sainte Elisabeth
Namur
Benoit MOONS, benoit.moons@chuuclnamur.uclouvain.be
Benoit MOONS
- Not yet recruiting
Clinique Saint-Pierre Ottignies (CSPO)
Ottignies, 1340
Lucie Verreth, Dr
Lucie Verreth, Dr
- Recruiting
CHWAPI
Tournai, 7000
Marc WAYEMBERGH, MD
Céline PETIT, MD
Romania1 site, 1 recruiting
- Not yet recruiting
Spitalul Nicolae Malaxa
Bucharest, 022448
Antoine Edu, Doctor, +40 723 341 753, antoine.edu@umfcd.ro
About this study
Official title: 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.
In Belgium, since 2025, HPV testing has become the primary screening method for cervical cancer. For women between 30 and 64 years, a clinical guideline (March 2025) from Sciensano stated the following " The triage of HPV-positive women is based on HPV type and reflex cytology outcome as a threshold for colposcopy. In 30- to 64-year-olds, triage of HR-HPV non-16/18 positives consists of an initial reflex cytology, followed by another HPV test 12 months later if the first step demonstrated Negative for Intraepithelial Lesion or Malignancy (NILM). Women who test positive on the initial HR-HPV test for the most high-risk HPV types 16 or 18 are immediately referred for colposcopy. Besides colposcopy, a reflex cytology will be performed. ". Women from 25 to 29 years are recommended to undergo a cytology testing on cervical smear as primary screening method following Sciensano clinical guideline (March 2025) recommendations. If abnormalities are detected, a HPV testing is performed. For the two age groups, if low grade abnormalities are detected with a diagnosis of HR-HPV, a second triage is recommended at 12 months.
Read more
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.
Read the detailed description
The study duration will be 72 months with 60 months of inclusion (that may be extended if the expected number of patients is not reached after 60 months) and 12 months of follow-up.
Patients aged between 25 and 45 years presenting a diagnosis of HR-HPV infection 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,
- Evolution of cytology,
- Normalization of cytology for the subpopulation of patients with a baseline non normal cytology,
- Safety: adverse events (AEs) and serious adverse events (SAEs), considered as related or not to the study drug.
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.
- Conditions
- Human Papilloma Virus
- Being tested
- 2LPAPI®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2LPAPI®Drug
Also called 2LPAPI
Treatment
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 2LPAPI® arm | Experimental | 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. Receives: Drug: 2LPAPI® |
| Placebo arm | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 6 months
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.
Measured: 6 and 12 months
Evolution of cytology (normalization, stagnation or worsening) at 6-month and 12-month visits.
The objective of this outcome will be to compare the evolution of the cytology at 6-month and 12-month visits.
Measured: 6 and 12 months
Normalization of cytology at 6-month and 12-month visits for the subpopulation of patients with a baseline non-normal cytology.
The objective of this outcome will be to compare the number of patients with a normal cytology at 6-month and 12-month visits in the subpopulation of patients with a baseline non-normal cytology.
Measured: 6 and 12 months
Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start17 Oct 2020
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Labo'Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEBIS International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232917
- Sponsor's protocol ID
- LLB-2017-01
- Acronym
- PAPION
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2020
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.
- ClinicalTrials.gov ID
- NCT04232917
- Acronym / sponsor ID
- PAPION / LLB-2017-01
- Conditions
- Human Papilloma Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Labo'LifeIndustry (pharma, biotech, devices)
- Collaborators
- CEBIS International
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Human papillomavirus (HPV) is a prevalent pathogen, the epidemiology of which has mostly been studied in the uterine cervix and the vagina.
In Belgium, since 2025, HPV testing has become the primary screening method for cervical cancer. For women between 30 and 64 years, a clinical guideline (March 2025) from Sciensano stated the following " The triage of HPV-positive women is based on HPV type and reflex cytology outcome as a threshold for colposcopy. In 30- to 64-year-olds, triage of HR-HPV non-16/18 positives consists of an initial reflex cytology, followed by another HPV test 12 months later if the first step demonstrated Negative for Intraepithelial Lesion or Malignancy (NILM). Women who test positive on the initial HR-HPV test for the most high-risk HPV types 16 or 18 are immediately referred for colposcopy. Besides colposcopy, a reflex cytology will be performed. ". Women from 25 to 29 years are recommended to undergo a cytology testing on cervical smear as primary screening method following Sciensano clinical guideline (March 2025) recommendations. If abnormalities are detected, a HPV testing is performed. For the two age groups, if low grade abnormalities are detected with a diagnosis of HR-HPV, a second triage is recommended at 12 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 72 months with 60 months of inclusion (that may be extended if the expected number of patients is not reached after 60 months) and 12 months of follow-up.
Patients aged between 25 and 45 years presenting a diagnosis of HR-HPV infection 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,
- Evolution of cytology,
- Normalization of cytology for the subpopulation of patients with a baseline non normal cytology,
- Safety: adverse events (AEs) and serious adverse events (SAEs), considered as related or not to the study drug.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2LPAPI® arm | Experimental | Drug: 2LPAPI®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 arm | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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 LSIL or CIN I at the histology,
- Patient with current cytology presenting normal, ASC-US, AGUS, LSIL, ASC-H, AGC or LSIL+ASC-H results or current diagnosis of CIN I at the histology,
- Patient with HR-HPV diagnosis at the current cervical collection,
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding woman,
- Patient presenting HSIL diagnosis at the cytology or CIN II or CIN III diagnosis at the histology,
- Patient having received HPV vaccination in the last month,
- Patient previously subject to total hysterectomy,
- Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2LPAPI®Also: 2LPAPITreatment | Drug | 2LPAPI® arm |
| PlaceboPlacebo | Drug | Placebo arm |
Primary outcome
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.
5 secondary outcomes
Comparison of 2LPAPI® versus placebo on HR-HPV infection clearance rate at 6-month visits.
Time frame: 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
Evolution of cytology (normalization, stagnation or worsening) at 6-month and 12-month visits.
Time frame: 6 and 12 months
Normalization of cytology at 6-month and 12-month visits for the subpopulation of patients with a baseline non-normal cytology.
Time frame: 6 and 12 months
Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- European platform for clinical trialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte BOLLE contact
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2LPAPI® in people with Human Papilloma Virus, run by Labo'Life at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura FERTE (+32499717964, laura.ferte@labolife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.