Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brivudine, Famciclovir.
- Who it may be relevant to
- Registry conditions: Herpes Zoster. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster: A Multicenter, Randomized, Prospective Clinical Trial
Overview
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.
Interventions
- Drug Brivudine
brivudine 125 mg per dose, once daily, 7 days - Drug Famciclovir
orally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days
Primary outcome measures
- Day 30 numeric pain rating scale (NPRS) [Time frame: Day 30]
Secondary outcome measures (7)
- numeric pain rating scale (NPRS) on Day 3, Day 7, Day 14, Day 90 [Time frame: Day 3, Day 7, Day 14, Day 90]
- Incidence of PHN [Time frame: 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]
- 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]
- cessation of new lesion formation [Time frame: 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]
- Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: From baseline to Day 30]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Peking University Third Hospital — Beijing
- Beijing Hospital of Traditional Chinese Medicine, Capital Medical University — Beijing
- Peking University First Hospital — Beijing
- Xuanwu Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT07099157 · M20250600