A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster

Sponsor
Shanghai Institute Of Biological Products
Study ID
NCT05492591
Phase
PHASE2
Status
Completed

Conditions

  • Herpes Zoster

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Peginterferon α1b — DRUG
    Injecting different doses of the peginterferon α1b into different groups of subjects.
  • Peginterferon α1b with valacyclovir — DRUG
    Both valacyclovir tablets and different dose of peginterferon α1b plan to be used in different groups of subjects.
  • Valacyclovir — DRUG
    Valacyclovir is a positive control drug.

Study Details

To evaluate the efficacy, optimal dose and efficacy trend of multiple subcutaneous injections of peginterferon α1b in patients with herpes zoster, and provide support for phase III clinical trials.

Key Dates

Start date
Oct 11, 2022
Status verified
Dec 2023
Primary completion
Jul 22, 2023
Completion
Jul 22, 2023

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    5 μg/kg of peginterferon α1b for injection in patients with herpes zoster.
  • Experimental: Group 2
    6 μg/kg of peginterferon α1b for injection in patients with herpes zoster.
  • Experimental: Group 3
    7 μg/kg of peginterferon α1b for injection in patients with herpes zoster.
  • Experimental: Group 4
    Both valacyclovir tablets and 6 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster.
  • Experimental: Group 5
    Both valacyclovir tablets and 7 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster.
  • Active Comparator: Group 6
    Only valacyclovir tablets in patients with herpes zoster, positive drug control group.

Primary Outcome Measure

Time of stop increasing new blisters/pimples [ Time Frame: 5 days after the first dose ]

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