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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Xuanwu Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Contact Information
Primary
Jin-Zhu Guo, M.D.
guojinzhu_826@163.com
008613521115717
Time Frame
Start Date: 2025-08-25
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 140
Treatments
Experimental: Brivudine Group
Active_comparator: Famciclovir Group
Related Therapeutic Areas
Sponsors
Leads: Peking University Third Hospital
Collaborators: Air Force Military Medical University, China, Xuanwu Hospital, Beijing, Peking University First Hospital, Beijing Hospital of Traditional Chinese Medicine

This content was sourced from clinicaltrials.gov