A Phase 2 Open Label Clinical Trial to Determine the Effect of Famciclovir on Epstein-Barr Virus Activity as Measured by EBV Shedding in Saliva of Patients With Multiple Sclerosis.
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effect of famciclovir on Epstein-Barr virus (EBV) shedding
研究概览
简要总结
This is a proof-of-concept study in 30 patients with established Relapsing Remitting Multiple Sclerosis (RRMS). IMP is Famciclovir. It is a phase II type A open label study. Each individuals participation in the study will last 36 weeks and will be divided into three phases: pre-treatment (12 weeks), treatment with famciclovir (12 weeks), and post-treatment (12 weeks). During the first 12 week phase patients will remain on their usual treatment alone; this will be followed by three months of co-treatment with famciclovir and then followed by a final three months post-famciclovir treatment where participants will continue to take their usual treatment for RRMS. The primary aim is to explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) shedding in the saliva of patients with MS
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with MS
- •Males and females aged over 18
- •Taking Natalizumab (Tysabri) for the treatment of MS,
- •Be able to provide informed consent to take part in this study.
- •Female patients of childbearing potential (defined in section 13.4) must be willing to follow protocol contraceptive requirements.
排除标准
- •Taking MS disease modifying treatment other than natalizumab (Tysabri)
- •On no treatment for MS
- •Taking additional immunomodulatory agents (either for MS treatment or other reasons)
- •Has received a course of high dose oral or intravenous steroids within 3 months of study entry. The use of low dose (total daily dose <10mg) and/or the use of topical steroids will not act as an exclusion criteria.
- •Taking antiviral or antiretroviral medication for any reason
- •Known allergy to penciclovir, acyclovir, valaciclovir or famciclovir
- •Taking probenecid
- •Significant renal (CKD 3 or 4) and/or liver (ALT>3x ULN) impairment
- •Pregnant, or unwilling to take measures to prevent pregnancy
- •Breastfeeding
研究组 & 干预措施
Single arm
干预措施: Famciclovir (Drug)
结局指标
主要结局
Effect of famciclovir on Epstein-Barr virus (EBV) shedding
时间窗: Baseline to 36 Weeks
The primary outcome of this study is quantification of Epstein-Barr virus (EBV) shedding in saliva in the IMP treatment phase (famciclovir 500mg BD) and post treatment phase of the Study compared with Epstein-Barr virus (EBV) shedding in saliva in the pre-treatment phase of the Study Shedding is defined as EBV DNA levels in saliva \>5.8 copies/ml.
次要结局
未报告次要终点