Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster

Not Applicable

Not yet recruiting

• Conditions: Herpes Zoster
• Interventions: Drug: Brivudine; Drug: Famciclovir

• Registration Number: NCT07099157
• Lead Sponsor: Peking University Third Hospital

Brief 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.

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 Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-18
• Study First Submitted QC: 2025-07-25
• Last Update Submitted: 2025-07-25
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-01
• Study Start: 2025-09-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brivudine Group	Brivudine	-
Famciclovir Group	Famciclovir	-

Primary Outcome Measures

Name	Time	Method
Day 30 numeric pain rating scale (NPRS)	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.

Secondary Outcome Measures

Name	Time	Method
numeric pain rating scale (NPRS) on Day 3, Day 7, Day 14, Day 90	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.
Incidence of PHN	Day 90	Incidence of Postherpetic Neuralgia
skin lesion on Day 3, Day 7, Day 14, Day 30, Day 90	Day 3, Day 7, Day 14, Day 30, Day 90	whether the presence of hemorrhagic bullae, bullae, erosions, or ulcers
complete crusting of all lesions	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
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	Percentage of body surface area (BSA%) affected by lesions on 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	whether cessation of new papule/vesicle formation on Day 3, Day 7, Day 14, Day 30 and Day 90
Adverse Events (AEs) and Serious Adverse Events (SAEs)	From baseline to Day 30	Adverse Events (AEs) and Serious Adverse Events (SAEs) in 30 days

Trial Locations

Locations (4)

Air Force Medical Center, PLA; 🇨🇳 Beijing, China

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University; 🇨🇳 Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, China

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China