Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster

NCT07099157 | Recruiting Phase 4 DMC

• 1 other identifier: M20250600
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

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.

Conditions

Herpes Zoster

Keywords

Herpes Zoster; Brivudine; pain; treatment

Outcome Measures

Primary Outcomes (1)

• Day 30 numeric pain rating scale (NPRS)

  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 Outcomes (7)

• numeric pain rating scale (NPRS) on Day 3, Day 7, Day 14, Day 90

  Day 3, Day 7, Day 14, Day 90

• Incidence of PHN

  Day 90

• skin lesion on Day 3, Day 7, Day 14, Day 30, Day 90

  Day 3, Day 7, Day 14, Day 30, 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

• cessation of new lesion formation

  Day 3, Day 7, Day 14, Day 30 and Day 90

Study Arms (2)

Brivudine Group

EXPERIMENTAL

Drug: Brivudine

Famciclovir Group

ACTIVE COMPARATOR

Drug: Famciclovir

Interventions

Brivudine DRUG

brivudine 125 mg per dose, once daily, 7 days

Brivudine Group

Famciclovir DRUG

orally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days

Famciclovir Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: collaborator
• Peking University Third Hospital: lead
• Peking University First Hospital: collaborator
• Air Force Military Medical University, China: collaborator
• Beijing Hospital of Traditional Chinese Medicine: collaborator

Study Sites (4)

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Beijing, China

RECRUITING

Peking University First Hospital

Beijing, China

RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, China

NOT YET RECRUITING

MeSH Terms

Conditions

Herpes Zoster; Pain

Interventions

brivudine; Famciclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Jin-Zhu Guo, M.D.

CONTACT

008613521115717; guojinzhu_826@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Blinded Investigator conduct the follow-ups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Dermatology

Model Details: Participants receive either Brivudine (125mg/day) or Famciclovir (dose-adjusted by creatinine clearance) for 7 days.

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 1, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)