Herpes ZosterPhase 4NCT07099157
Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster
A Phase 4 study testing Brivudine and Famciclovir in people with Herpes Zoster, run by Peking University Third Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Brivudine and Famciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesChina
- Study dates
- 25 Aug 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Jinzhu Guo, M.D., 008615611963350, guojinzhu_826@163.com
- Recruiting
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing
Dongmei Zhou, M.D., 008613811201580, 52176857@163.com
- Recruiting
Peking University First Hospital
Beijing
Xiaowen Wang, M.D., 008615901254602, xiaowenpku@126.com
- Not yet recruiting
Xuanwu Hospital, Capital Medical University
Beijing
Haiping Zhang, M.D., 008613701205765, zhanghaiping@xwhosp.org
About this study
Official title: Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster: A Multicenter, Randomized, Prospective Clinical Trial
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.
Read the 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
- Herpes Zoster
- Being tested
- Brivudine, Famciclovir
- Keywords
- Herpes Zoster, Brivudine, pain, treatment
- Medical subject headings
- Herpes Zoster, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivudineDrug
brivudine 125 mg per dose, once daily, 7 days
FamciclovirDrug
orally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days
| Study group | Role | What they receive |
|---|---|---|
| Brivudine Group | Experimental | Not described Receives: Drug: Brivudine |
| Famciclovir Group | Active comparator | Not described Receives: Drug: Famciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 30 numeric pain rating scale (NPRS)
Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.
Measured: Day 30
Secondary outcomes (7)
numeric pain rating scale (NPRS) on Day 3, Day 7, Day 14, Day 90
Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.
Measured: Day 3, Day 7, Day 14, Day 90
Incidence of PHN
Incidence of Postherpetic Neuralgia
Measured: Day 90
skin lesion on Day 3, Day 7, Day 14, Day 30, Day 90
whether the presence of hemorrhagic bullae, bullae, erosions, or ulcers
Measured: Day 3, Day 7, Day 14, Day 30, Day 90
Lesion area on Day 3, Day 7, Day 14, Day 30 and Day 90
Percentage of body surface area (BSA%) affected by lesions on Day 3, Day 7, Day 14, Day 30 and Day 90
Measured: Day 3, Day 7, Day 14, Day 30 and Day 90
cessation of new lesion formation
whether cessation of new papule/vesicle formation on Day 3, Day 7, Day 14, Day 30 and Day 90
Measured: Day 3, Day 7, Day 14, Day 30 and Day 90
complete crusting of all lesions
whether complete crusting of all lesions Day 3, Day 7, Day 14, Day 30 and Day 90
Measured: Day 3, Day 7, Day 14, Day 30 and Day 90
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events (AEs) and Serious Adverse Events (SAEs) in 30 days
Measured: From baseline to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start25 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants receive either Brivudine (125mg/day) or Famciclovir (dose-adjusted by creatinine clearance) for 7 days.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Air Force Military Medical University, China, Beijing Hospital of Traditional Chinese Medicine, Xuanwu Hospital, Beijing
- Responsible party
- Principal investigator, Guo Jin-Zhu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099157
- Sponsor's protocol ID
- M20250600
- Status last verified
- Dec 2025
- First submitted
- 18 Jul 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster: A Multicenter, Randomized, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07099157
- Acronym / sponsor ID
- M20250600
- Conditions
- Herpes Zoster
- Keywords
- Herpes Zoster, Brivudine, pain, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Air Force Military Medical University, China, Beijing Hospital of Traditional Chinese Medicine, Xuanwu Hospital, Beijing
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants receive either Brivudine (125mg/day) or Famciclovir (dose-adjusted by creatinine clearance) for 7 days.
| Arm | Type | Receives |
|---|---|---|
| Brivudine Group | Experimental | Drug: Brivudine |
| Famciclovir Group | Active comparator | Drug: Famciclovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brivudinebrivudine 125 mg per dose, once daily, 7 days | Drug | Brivudine Group |
| Famciclovirorally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days | Drug | Famciclovir Group |
Primary outcome
Day 30 numeric pain rating scale (NPRS)
Time frame: Day 30
Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brivudine and Famciclovir in people with Herpes Zoster, run by Peking University Third Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin-Zhu Guo, M.D. (008613521115717, guojinzhu_826@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 30 numeric pain rating scale (NPRS) (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.