Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster
Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster: A Multicenter, Randomized, Prospective Clinical Trial
Peking University Third Hospital
140 participants
Aug 25, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria6
- 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.
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Interventions
brivudine 125 mg per dose, once daily, 7 days
orally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT07099157