Trial intelligence / Profile preview

Peginterferon α1b in Patients With Herpes Zoster

NCT05492591Phase 2

Key facts

Status
Completed
Start
Oct 2022
Primary completion
Jul 2023
Countries
1
Modality
Polymer-based Nanoparticles, Cytokines & Interferons
Conditions
herpes zoster (HZ)
01

Overview

Phase 2, randomised trial of peginterferon alfa-1b in herpes zoster (HZ) (6 arms), sponsored by Shanghai Institute of Biological Products. Primary endpoints: Time of stop increasing new blisters/pimples at 5 days, Time of target herpes begins to scab at 7 days and 1 more. Started Oct 2022; status: completed.

02

Design

6 arms
Study design
Randomized
  • Peginterferon α1b 5 μg/kg

    5 μg/kg Peginterferon α1b

  • Peginterferon α1b 6 μg/kg

    6 μg/kg Peginterferon α1b

  • Peginterferon α1b 7 μg/kg

    7 μg/kg Peginterferon α1b

  • Combo 6 μg/kg

    6 μg/kg Peginterferon α1b + Valacyclovir

  • Combo 7 μg/kg

    7 μg/kg Peginterferon α1b + Valacyclovir

  • Valacyclovir

    Valacyclovir tablets

03

Who it enrols

Adult patients (18-75 years) with clinically diagnosed Herpes Zoster (within 72 hours of rash) and moderate to severe pain (VAS ≥3).

04

Endpoints

Primary

  • Time of stop increasing new blisters/pimples

  • Time of target herpes begins to scab

  • Time of complete scabbing of all herpes

Secondary

  • Changes in VAS scores from baseline

  • Time that VAS score to drop to ≤2

  • Duration time that VAS score to drop to ≤2

  • The time that scabs of blisters fall off

  • Dose of painkiller

  • Incidence of postherpetic neuralgia

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