Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster

Peking University

Status and phase: Enrolling; Phase 4

Conditions: Herpes Zoster

Treatments: Drug: Famciclovir; Drug: Brivudine

Study type: Interventional

Funder types: Other

Identifiers

NCT07099157

M20250600

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years, regardless of gender;

2. Signed Informed Consent Form;

3. 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 criteria

1. Allergy to brivudine, famciclovir, or penciclovir;
2. Current use of fluorouracil agents (e.g., 5-fluorouracil, capecitabine, tegafur, flucytosine);
3. Cancer patients currently undergoing chemotherapy;
4. Pregnant or lactating women;
5. Parkinson's disease;
6. Any condition deemed inappropriate for study participation by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Brivudine Group

Experimental group

Treatment:

Drug: Brivudine

Famciclovir Group

Active Comparator group

Treatment:

Drug: Famciclovir