Randomized, Double-blind, Parallel, Controlled Clinical Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV-16 and/or HPV-18 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
- difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
研究概览
简要总结
to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for the treatment of patients with cervical HPV-16 and/or HPV-18 infections; to analyze the HPV type infections and clinical negative conversion.
详细描述
100 patients with positive HPV-16 and HPV-18 infection are randomized into interferon gel group and control group at ratio of 1:1 (50 patients in treatment group and 50 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment, whereas no treatment was conducted in control group.
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 with the sex life of female patients;
- •HPV DNA typing test for HPV-16 and/ or HPV-18 positive in 1 month.
排除标准
- •Patients with cervical intraepithelial neoplasia Ⅱ / Ⅲ, cervical cancer;
- •Associated with fungal vaginitis, trichomonas vaginitis, HIV positive patients;
- •Associated with acute, severe bacterial or viral infection;
- •Autoimmune diseases;
- •Within 3 months before screening patients used corticosteroids, immunosuppressants or other antiviral drugs;
- •Allergies or allergy to the drug known ingredients;
- •History of suffering CNS diseases, epilepsy and/or psychological disorder;
- •Pregnant and lactating women;
- •The researchers do not consider it appropriate clinical trials.
研究组 & 干预措施
Treatment group
received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment
干预措施: Yallaferon®， the recombinant human interferon α-2b gel (Drug)
controlled group
received 1g gel (without biological active ingredient) every other day for consecutive 6-10 courses of treatment
干预措施: gel without active ingredient (Other)
结局指标
主要结局
difference of HPV-16 and/ or HPV-18 DNA negative conversion rate
时间窗: three months
Primary efficacy endpoint was the difference of HPV-16 and/ or HPV-18 DNA negative conversion rate on the 3th month between the two groups.
次要结局
- difference of HPV-16 and/ or HPV-18 DNA negative conversion rate(six months, nine months and twelve months)
- The recurrent rate of HPV-16 and/ or HPV-18 DNA among patients with negative-conversion result between the two groups(1 year)