NCT01765114终止2 期
A Phase II Open-label, Intra-individual Controlled, Single-center Study to Investigate the Efficacy, Safety and Tolerability of a Polyethylene Glycol-formulation and the Viral Shedding in Patients Suffering From Genital Herpes
Devirex AG1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年2月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change of number of genital herpes recurrences during the treatment period as compared to the baseline period.
研究概览
简要总结
The aim of this study is therefore to investigate the efficacy of the PEG-formulation to reduce the frequency and duration of genital herpes recurrences, to assess its safety and tolerability and to investigate its effect on shedding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent
- •18 - 65 years
- •Positive for HSV-1 and/or -2 (as determined by serology testing in course of study)
- •Initial infection > 1 year ago
- •≥ 6 recurrences in the last year (or in the year prior to a recent prophylactic therapy)
- •≥ 2 recurrences during the six-month baseline period
排除标准
- •Known or suspected allergy or intolerability to PEG
- •Prophylactic antiviral drugs, virostatic agents, cytostatics, immunomodulatory drugs and steroids within less than 14 days prior to baseline period, or plan to take such drugs during the trial
- •Pregnancy and/or breast-feeding
- •History of malignant diseases (described in chapter 7.2)
- •Known or suspected non-compliance to study protocol
- •Participation in another investigational drug study in the last 30 days prior to baseline period
研究组 & 干预措施
PEG-Formulation
Experimental
PEG-Formulation, applied twice daily during the treatment period (duration: 6 months)
干预措施: PEG-Formulation (Drug)
结局指标
主要结局
Change of number of genital herpes recurrences during the treatment period as compared to the baseline period.
时间窗: Baseline and Treatment period (6 months each).
The number of genital herpes recurrences will be counted during the baseline period (6 months) and during the treatment period (6 months) and then be compared.
次要结局
- The safety of the PEG-formulation via reporting of AEs.(Baseline and Treatment period (6 months each).)
研究者
研究点 (1)
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