Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster

Sponsored by Peking University Third Hospital

About this trial

Last updated 4 months ago

Study ID

M20250600

Status

Recruiting

Type

Interventional

Phase

Phase 4

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started 8 months ago

What is this trial about?

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.

What are the participation requirements?

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.