Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster

December 28, 2025 updated by: Guo Jin-Zhu, Peking University Third Hospital

Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster: A Multicenter, Randomized, Prospective Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, China
        • Recruiting
        • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
        • Contact:
      • Beijing, China
        • Not yet recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brivudine Group
Drug: Brivudine
brivudine 125 mg per dose, once daily, 7 days
Active Comparator: Famciclovir Group
Drug: Famciclovir
orally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Day 30 numeric pain rating scale (NPRS)
Time Frame: 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.
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
numeric pain rating scale (NPRS) on Day 3, Day 7, Day 14, Day 90
Time Frame: Day 3, Day 7, Day 14, Day 90
Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.
Day 3, Day 7, Day 14, Day 90
Incidence of PHN
Time Frame: Day 90
Incidence of Postherpetic Neuralgia
Day 90
skin lesion on Day 3, Day 7, Day 14, Day 30, Day 90
Time Frame: Day 3, Day 7, Day 14, Day 30, Day 90
whether the presence of hemorrhagic bullae, bullae, erosions, or ulcers
Day 3, Day 7, Day 14, Day 30, Day 90
Lesion area on Day 3, Day 7, Day 14, Day 30 and Day 90
Time Frame: Day 3, Day 7, Day 14, Day 30 and Day 90
Percentage of body surface area (BSA%) affected by lesions 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
Time Frame: Day 3, Day 7, Day 14, Day 30 and Day 90
whether cessation of new papule/vesicle formation on Day 3, Day 7, Day 14, Day 30 and Day 90
Day 3, Day 7, Day 14, Day 30 and Day 90
complete crusting of all lesions
Time Frame: Day 3, Day 7, Day 14, Day 30 and Day 90
whether complete crusting of all lesions Day 3, Day 7, Day 14, Day 30 and Day 90
Day 3, Day 7, Day 14, Day 30 and Day 90
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From baseline to Day 30
Adverse Events (AEs) and Serious Adverse Events (SAEs) in 30 days
From baseline to Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

Peking University First Hospital
Xuanwu Hospital, Beijing
Air Force Military Medical University, China
Beijing Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 18, 2025

First Submitted That Met QC Criteria

July 25, 2025

First Posted (Actual)

August 1, 2025

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20250600

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Herpes Zoster

Clinical Trials on Brivudine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe