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

NCT04232917 | Recruiting Phase 4

• 1 other identifier: LLB-2017-01
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 12

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.

Conditions

Human Papilloma Virus

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (5)

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

  6 months

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

  6 and 12 months

• Evolution of cytology (normalization, stagnation or worsening) at 6-month and 12-month visits.

  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.

  6 and 12 months

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

  6 months

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

2LPAPI® DRUG

Treatment

Also known as: 2LPAPI

2LPAPI® arm

Placebo DRUG

Placebo

Placebo arm

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Labo'Life: lead

Study Sites (12)

CHU Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

Clinique St Jean

Brussels, 1000, Belgium

RECRUITING

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

Hôpitaux Iris Sud - Iris Zuid Ziekenhuis

Brussels, 1050, Belgium

RECRUITING

Hôpital Civil Marie Curie ISPPC

Charleroi, 6042, Belgium

ACTIVE NOT RECRUITING

Centre Hospital Reine Astrid Malmedy (CHRAM)

Malmedy, 4960, Belgium

ACTIVE NOT RECRUITING

Belgium

Namur, 5000, Belgium

RECRUITING

Belgium

Namur, 5000, Belgium

ACTIVE NOT RECRUITING

Cabinet privé

Namur, 5000, Belgium

RECRUITING

UCL Namur - site Sainte Elisabeth

Namur, Belgium

RECRUITING

Clinique Saint-Pierre Ottignies (CSPO)

Ottignies, 1340, Belgium

NOT YET RECRUITING

CHWAPI

Tournai, 7000, Belgium

RECRUITING

Central Study Contacts

Laura FERTE

CONTACT

+32499717964; laura.ferte@labolife.com

Charlotte BOLLE

CONTACT

charlotte.bolle@labolife.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: October 17, 2020
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

BE (12)