Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster: A Multicenter, Randomized, Prospective Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Day 30 numeric pain rating scale (NPRS)
研究概览
简要总结
This multicenter RCT aims to compare the efficacy and safety of Brivudine versus Famciclovir in treating acute herpes zoster. Primary objective: Evaluate pain reduction via Numeric Pain Rating Scale (NPRS) at Day 30. Secondary objectives: Compare NPRS at Day 3/Day 7/Day 14/Day 90, time to lesion resolution, Postherpetic Neuralgia (PHN) incidence, and safety.
详细描述
A randomized controlled trial enrolling 140 participants from 5 centers in China. Patients receive either Brivudine (125mg/day) or Famciclovir (dose-adjusted by creatinine clearance) for 7 days. Follow-ups occur at Day 3, Day 7, Day 14, Day 30, Day 90. Primary endpoint: Numeric Pain Rating Scale (NPRS) at Day 30; secondary endpoints: NPRS at other timepoints, lesion healing time, Postherpetic Neuralgia (PHN) rate, and adverse events.
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
- Single (Investigator)
盲法说明
Blinded Investigator conduct the follow-ups.
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
- •Age ≥18 years, regardless of gender;
- •Signed Informed Consent Form;
- •Female subjects must not plan for pregnancy or oocyte donation from screening until 1 week after the last dose and must voluntarily adopt highly effective physical contraception; male subjects must not plan for fertility or sperm donation during the same period and must voluntarily adopt highly effective physical contraception. Methods include:
- •Barrier methods: Condom or barrier cap (diaphragm or cervical cap);
- •Intrauterine device (IUD) or intrauterine system (IUS);
- •Surgical sterilization (bilateral oophorectomy with/without hysterectomy, total hysterectomy, bilateral tubal ligation, or vasectomy) performed ≥6 months prior to the first dose in the subject or their partner;
- •Other investigator-confirmed highly effective physical contraception.
排除标准
- •Allergy to brivudine, famciclovir, or penciclovir;
- •Current use of fluorouracil agents (e.g., 5-fluorouracil, capecitabine, tegafur, flucytosine);
- •Cancer patients currently undergoing chemotherapy;
- •Pregnant or lactating women;
- •Parkinson's disease;
- •Any condition deemed inappropriate for study participation by the investigator.
研究组 & 干预措施
Brivudine Group
干预措施: Brivudine (Drug)
Famciclovir Group
干预措施: Famciclovir (Drug)
结局指标
主要结局
Day 30 numeric pain rating scale (NPRS)
时间窗: Day 30
Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.
次要结局
- numeric pain rating scale (NPRS) on Day 3, Day 7, Day 14, Day 90(Day 3, Day 7, Day 14, Day 90)
- Incidence of PHN(Day 90)
- skin lesion on Day 3, Day 7, Day 14, Day 30, Day 90(Day 3, Day 7, Day 14, Day 30, Day 90)
- complete crusting of all lesions(Day 3, Day 7, Day 14, Day 30 and Day 90)
- Lesion area on Day 3, Day 7, Day 14, Day 30 and Day 90(Day 3, Day 7, Day 14, Day 30 and Day 90)
- cessation of new lesion formation(Day 3, Day 7, Day 14, Day 30 and Day 90)
- Adverse Events (AEs) and Serious Adverse Events (SAEs)(From baseline to Day 30)
研究者
Guo Jin-Zhu
Deputy Director of Dermatology
Peking University Third Hospital