Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 2:32 AM
Study NCT ID:
NCT07099157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster
Sponsor:
Peking University Third Hospital
Organization:
Study Overview
Official Title:
Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster: A Multicenter, Randomized, Prospective Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: