a Multi-sites, Randomized, Parallel, Placebo-Controlled Clinical, Pilot Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV Infection
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- HPV-16 and/or HPV-18 negative conversion rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 25 to 65 years of age the sex life of female patients;
- •High-risk HPV 16 and/or 18 positive
- •Agree to sign ICF
排除标准
- •Cervical intraepithelial neoplasia (CIN);
- •Combined with a severe fungal, trichomonas vaginitis;
- •Severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system;
- •Allergies or allergy to the drug known ingredients.
- •Within 30 days to accept other clinical trials of drugs or are participating in clinical trials;
- •Pregnant and lactating women and to be pregnant women;
- •The researchers do not consider it appropriate clinical trials.
研究组 & 干预措施
Treatment
subject were treated 3 periods with Yallaferon®; each period has interval 10 days ; one period included Yallaferon application for every other day for 10 times
干预措施: Recombinant Human Interferon a-2b Gel (Drug)
Plcaebo
subject were treated 3 periods with Yallaferon® Plcaebo; each period has interval 10 days; one period included Yallaferon application for every other day for 10 times
干预措施: Placebo (Drug)
结局指标
主要结局
HPV-16 and/or HPV-18 negative conversion rate
时间窗: 3 months
hr-HPV DNA negative conversion rate will be evaluated at 3 months after treatment in treatment and placebo group; calculation method: proportion of patient with HPV negative expression
次要结局
- HPV-16 and/or HPV-18 negative conversion rate(12 months)
- reinfection at 12 months(12 months)