2024-513969-39-00招募中4 期
Randomized, placebo-controlled, double-blind study to evaluate 2LPAPI® efficacy on the clearance of genital HR-HPV infections (PAPION study)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 484
- 试验地点
- 18
- 主要终点
- HR-HPV infection clearance at 12-month visit.
研究概览
简要总结
Comparison of the efficacy of 2LPAPI® versus placebo on the clearance of genital HR-HPV infections after 12 months of follow-up.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 25 and 45 years old; - 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, 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 for the duration of the study); - Patient having the ability to understand and respect the constraints of the study; - Signature of the Informed Consent Form.
排除标准
- •Pregnant or breastfeeding women; - 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 a total hysterectomy; - Patient under immunotherapy treatment (including immunosuppressive treatments) or micro-immunotherapy received in the last six months; - Patient with known lactose intolerance; - Patient who has participated in a clinical study in the last three months; - Patient not sufficiently motivated to engage in a 12-month follow-up, or likely to travel or move before the end of the study; - Patient with severe immune deficiency requiring long-term treatment (*) or under chemotherapy or radiotherapy; - Patient under listed homeopathic or phytotherapy treatment (see list in the protocol); - Patient using or addicted to recreational drugs. (*) important renal or respiratory failure,
结局指标
主要结局
HR-HPV infection clearance at 12-month visit.
HR-HPV infection clearance at 12-month visit.
次要结局
- - HR-HPV infection clearance at 6-month visit; - HR-HPV infection clearance by HPV type at 6-month and 12-month visits; - Evolution of cytology (normalization, stagnation or aggravation) at 6-month and 12-month visits; - Normalization of cytology at 6-month and 12-month visits for the subpopulation of patients with a baseline non normal cytology, - Safety: adverse events (AEs) and serious adverse events (SAEs) considered as related or unrelated to the study drug.
研究者
Laura Ferté Clinical Project Manager
Scientific
Labo'Life Belgium
研究点 (18)
Loading locations...
相似试验
招募中
4 期
Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections.Human Papilloma VirusNCT04232917Labo'Life284
已完成
4 期
HPV Vaccination Study in Postpartum WomenHPVImmunizationHuman Papilloma VirusNCT04274153Johns Hopkins University225
终止
2 期
Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital SettingCOVID-19NCT04396106Atea Pharmaceuticals, Inc.83
撤回
2 期
NBP in Women With Metastatic Breast Cancer to Prevent Nab-paclitaxel Induced Toxic NeuropathyBreast CancerPeripheral NeuropathyNCT04675450Conjupro Biotherapeutics, Inc.
已完成
2 期
HTX-011 for Post-bunionectomy AnalgesiaAnalgesiaNCT02471898Heron Therapeutics71