Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.
NCT ID: NCT04232917
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
284 participants
INTERVENTIONAL
2020-10-17
2027-10-30
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
2LPAPI®
Treatment
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
Placebo
Interventions
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2LPAPI®
Treatment
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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,
* 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.
25 Years
45 Years
FEMALE
No
Sponsors
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Labo'Life
INDUSTRY
Responsible Party
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Locations
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CHU Saint-Pierre
Brussels, , Belgium
Clinique St Jean
Brussels, , Belgium
CHU Brugmann
Brussels, , Belgium
Hôpitaux Iris Sud - Iris Zuid Ziekenhuis
Brussels, , Belgium
Hôpital Civil Marie Curie ISPPC
Charleroi, , Belgium
Centre Hospital Reine Astrid Malmedy (CHRAM)
Malmedy, , Belgium
Belgium
Namur, , Belgium
Belgium
Namur, , Belgium
Cabinet privé
Namur, , Belgium
UCL Namur - site Sainte Elisabeth
Namur, , Belgium
Clinique Saint-Pierre Ottignies (CSPO)
Ottignies, , Belgium
CHWAPI
Tournai, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Yannick Manigart, Dr
Role: primary
Nathanaël DUBOIS
Role: primary
Tatiana Besse-Hammer, MD
Role: primary
Frédéric BUXANT, MD
Role: primary
Sarah MITRI
Role: primary
Benoit MOONS
Role: primary
Benoit MOONS
Role: primary
MD
Role: backup
Lucie Verreth, Dr
Role: primary
Marc WAYEMBERGH, MD
Role: primary
Other Identifiers
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LLB-2017-01
Identifier Type: -
Identifier Source: org_study_id