Open Controlled Randomized Study of the Efficacy and Safety of Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts (Phase III)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recurrence of anogenital warts
研究概览
简要总结
The primary purpose of this study is to evaluate the effectiveness of destructive therapy for anogenital warts in combination with the use of Ingaron in comparison with destructive therapy.
详细描述
Literature data and the results of preclinical studies of interferon-gamma, as well as the features of HPV immunopathogenesis, show the expediency of studying the use of Ingaron in this pathology.
The study was planned to include 50 outpatients of both sexes aged 18 to 50 years with a confirmed diagnosis of anogenital warts.
In the course of the study, Ingaron was administered at a dose of 100,000 IU once a day every other day in the period of 10 days.
Patients were divided into 2 groups: study and control.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged 18 to 50 years with a diagnosis of "Anogenital warts".
- •The diagnosis "Anogenital warts" was made for the first time at least one year before inclusion in the study.
- •During the last year prior to inclusion in the study, the patient had at least 2 recurrences of anogenital warts.
- •The diagnosis is confirmed by the detection of HPV by polymerase chain reaction (PCR).
- •Negative pregnancy test in women.
- •Availability of written informed consent to participate in the study.
排除标准
- •Positive test results for syphilis, hepatitis (HbsAg, anti-HCV), HIV infection, gonococcal infection, urogenital trichomoniasis, chlamydial infection, inflammatory diseases of the urogenital system caused by genital mycoplasmas.
- •Unsystematic use of barrier methods of contraception.
- •Pregnancy and lactation.
- •Known allergic reactions to interferons and / or other significant allergic diseases.
- •Any immunotropic therapy within the last 6 weeks prior to enrollment in the study.
- •The need to take drugs prohibited during the study.
- •Condition after organ transplantation, constant intake of immunosuppressive drugs.
- •Severe pathology from the cardiovascular system (uncontrolled arterial hypertension, unstable angina pectoris, congestive heart failure, cardiac arrhythmias), a history of myocardial infarction or cerebrovascular accident within the last 6 months.
- •Severe pathology on the part of the liver (increased content of AST, ALT 2 times higher than the upper limit of the norm, the content of total bilirubin> 2 mg / dL), kidney (content of creatinine> 1.5 mg / dL); signs of hepatic and / or renal failure.
- •The presence of severe pathology on the part of the respiratory system, gastrointestinal tract, hematopoietic system.
- •Other serious (acute or chronic) pathological conditions, including mental illness, as well as abnormalities in laboratory parameters, which, in the opinion of the investigator, may increase the risk associated with participation in the study or affect the interpretation of efficacy and safety data obtained in this research.
- •Alcohol and / or drug dependence.
- •Participation in other clinical trials in the last three months prior to inclusion.
研究组 & 干预措施
Interferon
After a cryodestruction session, therapy with Ingaron 100,000 IU once a day every other day. The course of treatment consisted of 5 injections.
干预措施: Interferon gamma human recombinant (IFN-G) (Drug)
结局指标
主要结局
Recurrence of anogenital warts
时间窗: Day 100
Number of participants with recurrent anogenital warts
次要结局
未报告次要终点