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RecruitingNCT07099157

Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster

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

Status
Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
140 (estimated)
Sponsor
Peking University Third Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGBrivudinebrivudine 125 mg per dose, once daily, 7 days
DRUGFamciclovirorally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days

Timeline

Start date
2025-08-25
Primary completion
2026-12-31
Completion
2027-12-31
First posted
2025-08-01
Last updated
2026-01-02

Locations

4 sites across 1 country: China

Source: ClinicalTrials.gov record NCT07099157. Inclusion in this directory is not an endorsement.