Randomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 284
- 试验地点
- 21
- 主要终点
- Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 2LPAPI® (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up.
时间窗: 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.
次要结局
- 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)