Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster

Last updated: July 25, 2025
Sponsor: Peking University Third Hospital
Overall Status: Active - Not Recruiting

Phase

4

Condition

Shingles

Chickenpox (Varicella Zoster Infection)

Herpes Simplex Infections

Treatment

Brivudine

Famciclovir

Clinical Study ID

NCT07099157
M20250600
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 physicalcontraception; male subjects must not plan for fertility or sperm donation duringthe 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, totalhysterectomy, bilateral tubal ligation, or vasectomy) performed ≥6 months priorto the first dose in the subject or their partner;

  • Other investigator-confirmed highly effective physical contraception.

Exclusion

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.

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Brivudine
Phase: 4
Study Start date:
September 01, 2025
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Air Force Medical Center, PLA

    Beijing,
    China

    Site Not Available

  • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

    Beijing,
    China

    Site Not Available

  • Peking University First Hospital

    Beijing,
    China

    Site Not Available

  • Xuanwu Hospital, Capital Medical University

    Beijing,
    China

    Site Not Available

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