Actively Recruiting
Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster: A Multicenter, Randomized, Prospective Clinical Trial
Led by Peking University Third Hospital · Updated on 2026-01-02
140
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Peking University Third Hospital
Lead Sponsor
P
Peking University First Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of two antiviral drugs, Brivudine and Famciclovir, in treating adults with acute herpes zoster. This multicenter, randomized controlled trial aims to compare how well these medications reduce pain using the Numeric Pain Rating Scale (NPRS) at various points, with the primary focus on pain at Day 30. The study also looks at healing time of skin lesions, incidence of Postherpetic Neuralgia (PHN), and safety outcomes in participants. Participants are randomly assigned to receive either Brivudine at a dose of 125 mg once daily for 7 days or Famciclovir dosed orally based on kidney function for the same duration. The treatment period lasts one week, with follow-up visits scheduled on Day 3, Day 7, Day 14, Day 30, and Day 90 to monitor effects and collect data on pain levels, lesion healing, and any adverse events. During the study, participants undergo pain assessments using the NPRS at multiple timepoints and evaluations of their skin lesions for healing progress. Researchers also track the development of Postherpetic Neuralgia up to Day 90 and monitor for any side effects or serious adverse events from baseline through Day 30. This comprehensive monitoring aims to ensure participant safety and gather detailed information on the treatments' impact over a three-month period.
CONDITIONS
Brief Title
Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Signed Informed Consent Form
- Female participants must not plan pregnancy or egg donation during screening until one week after last dose and must use highly effective physical contraception
- Male participants must not plan fertility or sperm donation during the same period and must use highly effective physical contraception
- Accepted contraception methods include barrier methods, intrauterine devices or systems, surgical sterilization performed at least 6 months prior, or other investigator-confirmed methods
You will not qualify if you...
- Allergy to brivudine, famciclovir, or penciclovir
- Current use of fluorouracil agents such as 5-fluorouracil, capecitabine, tegafur, or flucytosine
- Undergoing chemotherapy for cancer
- Pregnant or lactating women
- Diagnosis of Parkinson's disease
- Any condition considered inappropriate for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants receive Brivudine or Famciclovir daily for 7 days.
1 baseline visit and 4 follow-up visits on Days 3, 7, 14, and 30
Duration - Up to 90 days after treatment
Participants are monitored for safety and symptom resolution, including pain and lesion healing, with assessments continuing through Day 90.
1 visit on Day 90
Trial Site Locations
Total: 4 locations
1
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
2
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, China
Actively Recruiting
3
Peking University First Hospital
Beijing, China
Actively Recruiting
4
Xuanwu Hospital, Capital Medical University
Beijing, China
Not Yet Recruiting
Research Team
J
Jin-Zhu Guo, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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