RPCEC00000038已完成2 期
Intramuscular application of a new freeze-dried formulation of albumin-free recombinant human alpha-2b interferon in Acuminate Condyloma patients.
Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 30 人开始时间: 2010年12月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 60 years（—）
- 性别
- All
入选标准
- •Clinical and histological diagnosis positive to Acuminate Condyloma by papilloma virus. Patients of both sexes with Acuminate Condyloma lesions in external genitals, perianal region, and inner thighs. Patients aged 18 to 60. No topical or systemic treatment with IFN or any other antiviral drug one month before inclusion in the study. Reproductive-age women using any non-hormonal contraceptive. Patient’s consent in writing to participate in the study.
排除标准
- •Other sexually transmitted diseases (syphilis, infectious urethritis, AIDS). Antiviral or immunosuppressor (corticosteroid, cytostatic) therapy three months before commencing INF treatment. Severe systemic and chronic diseases affecting the patient’s general condition and modifying therapeutic response, including malignant neoplasias and immunodeficiency. Lesion sepsis demanding systemic antibiotic treatment. Pregnancy or breastfeeding. Patients with history of hypersensitivity to alpha INF or any formulation component.
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