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Non-inferiority Study of ZK-A03 in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient Manufacturer

Primary Purpose

Herpes Zoster

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Recombinant Human Interferon α-2b Gel (After the Alteration)
Recombinant Human Interferon α-2b Gel (Before the Alteration)
Sponsored by
Lee's Pharmaceutical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Zoster

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: Men and women aged between 18 and 70 years old. Diagnosed as herpes zoster. Time to appearance of lesions ≤ 72 hours prior to the first dosing (lesions may represent as: erythema, papules or blisters), lesion area ≤ 3% body surface area (BSA). Self-rated Numerical Rating Scale (NRS) in pain ≤ 6. Negative serum pregnancy test for women of reproductive age. Birth control from first dosing until 1 month after last dosing for all men and women of reproductive age. Subjects must have signed an informed consent form (ICF). Main Exclusion Criteria: Diagnosed as herpes zoster on face, visceral herpes zoster, herpes zoster meningitis, disseminated herpes zoster, zoster sine herpete or blood blisters and necrosis. The lesion is complicated with other skin diseases that may affect the evaluation of efficacy, Skin lesions combined with severe bacterial or fungal infections. Use of antiviral or analgesic therapy for herpes zoster within 2 weeks prior to the first dosing. Known allergies to recombinant human interferon α-2b and chemical structure analogs, valaciclovir or history of any drug, food or other allergy. Liver and/or renal disfunction,ie. Alanine aminotransferase (ALT), Aspartate transaminase (AST) > 2 times of upper normal limit(ULN); Creatinine Clearance Rate (CCR) < 50 L/min. Combined with immunodeficiency disease or require long-term glucocorticoid or immunosuppressive drugs. Combined with severe cardiovascular, respiratory, gastrointestinal or neurological disorders and remains unstable after treatment. History of psychiatric illness or inability to fully comply to the protocol. Use of another investigational product within 4 weeks prior to the first dosing. Pregnant or lactating women. Other conditions deemed by the investigator to be inappropriate for participation in this trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Recombinant Human Interferon α-2b Gel (After the Alteration)

    Recombinant Human Interferon α-2b Gel (Before the Alteration)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Clinical cure rate at visit 4 (Day 7)
    Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration.

    Secondary Outcome Measures

    Clinical cure rate at visit 3 (Day 4), and visit 5 (Day 11)
    Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration.
    Time to which new blisters stop appearing
    The time from the first day of medication (D1) to the cessation of new blisters.
    The time to beginning of crusting.
    The time from the first day of medication (D1) to the beginning of crusting.
    The time to which all blisters are crustosus.
    The time from the first day of medication (D1) to the crustosus of all blisters.
    The pain improvement rate at visit 4 (Day 7)
    Pain change of ≥1 from baseline is considered as pain improvement.

    Full Information

    First Posted
    March 20, 2023
    Last Updated
    April 7, 2023
    Sponsor
    Lee's Pharmaceutical Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05806918
    Brief Title
    Non-inferiority Study of ZK-A03 in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient Manufacturer
    Official Title
    A Multicenter, Randomized, Double-blind, Controlled, Non-inferiority Phase III Clinical Trial of Recombinant Human Interferon Alpha-2b Gel (ZK-A03) in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient Manufacturer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    July 30, 2023 (Anticipated)
    Study Completion Date
    August 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lee's Pharmaceutical Limited

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trail is to demonstrate the non-inferiority of recombinant human interferon α-2b gel (ZK-A03) after changing the manufacturer of the active ingredient in patients with herpes zoster. This double-blind study will enroll approximately 368 adult patients with herpes zoster in China. Eligible patients will be assigned randomly at a 1:1 ratio. For each patient who is included, treatment may last up to 10 days. During the study, subjects will be treated with recombinant human interferon α-2b gel (either before or after the alteration of the active ingredient manufacturer), at a frequency of four times a day, together with a background therapy of valaciclovir hydrochloride.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Herpes Zoster

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    368 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Recombinant Human Interferon α-2b Gel (After the Alteration)
    Arm Type
    Experimental
    Arm Title
    Recombinant Human Interferon α-2b Gel (Before the Alteration)
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Recombinant Human Interferon α-2b Gel (After the Alteration)
    Intervention Description
    Recombinant human interferon α-2b gel (after the alteration of the active ingredient manufacturer) will be applied to the lesions as a thin layer, at the frequency of four times a day, together with the therapy of valaciclovir hydrochloride.
    Intervention Type
    Drug
    Intervention Name(s)
    Recombinant Human Interferon α-2b Gel (Before the Alteration)
    Intervention Description
    Recombinant human interferon α-2b gel (before the alteration of the active ingredient manufacturer) will be applied to the lesions as a thin layer, at the frequency of four times a day, together with the therapy of valaciclovir hydrochloride.
    Primary Outcome Measure Information:
    Title
    Clinical cure rate at visit 4 (Day 7)
    Description
    Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration.
    Time Frame
    7 Days
    Secondary Outcome Measure Information:
    Title
    Clinical cure rate at visit 3 (Day 4), and visit 5 (Day 11)
    Description
    Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration.
    Time Frame
    11 Days
    Title
    Time to which new blisters stop appearing
    Description
    The time from the first day of medication (D1) to the cessation of new blisters.
    Time Frame
    11 Days
    Title
    The time to beginning of crusting.
    Description
    The time from the first day of medication (D1) to the beginning of crusting.
    Time Frame
    11 Days
    Title
    The time to which all blisters are crustosus.
    Description
    The time from the first day of medication (D1) to the crustosus of all blisters.
    Time Frame
    11 Days
    Title
    The pain improvement rate at visit 4 (Day 7)
    Description
    Pain change of ≥1 from baseline is considered as pain improvement.
    Time Frame
    7 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Main Inclusion Criteria: Men and women aged between 18 and 70 years old. Diagnosed as herpes zoster. Time to appearance of lesions ≤ 72 hours prior to the first dosing (lesions may represent as: erythema, papules or blisters), lesion area ≤ 3% body surface area (BSA). Self-rated Numerical Rating Scale (NRS) in pain ≤ 6. Negative serum pregnancy test for women of reproductive age. Birth control from first dosing until 1 month after last dosing for all men and women of reproductive age. Subjects must have signed an informed consent form (ICF). Main Exclusion Criteria: Diagnosed as herpes zoster on face, visceral herpes zoster, herpes zoster meningitis, disseminated herpes zoster, zoster sine herpete or blood blisters and necrosis. The lesion is complicated with other skin diseases that may affect the evaluation of efficacy, Skin lesions combined with severe bacterial or fungal infections. Use of antiviral or analgesic therapy for herpes zoster within 2 weeks prior to the first dosing. Known allergies to recombinant human interferon α-2b and chemical structure analogs, valaciclovir or history of any drug, food or other allergy. Liver and/or renal disfunction,ie. Alanine aminotransferase (ALT), Aspartate transaminase (AST) > 2 times of upper normal limit(ULN); Creatinine Clearance Rate (CCR) < 50 L/min. Combined with immunodeficiency disease or require long-term glucocorticoid or immunosuppressive drugs. Combined with severe cardiovascular, respiratory, gastrointestinal or neurological disorders and remains unstable after treatment. History of psychiatric illness or inability to fully comply to the protocol. Use of another investigational product within 4 weeks prior to the first dosing. Pregnant or lactating women. Other conditions deemed by the investigator to be inappropriate for participation in this trial.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jinghua Xu, MD
    Phone
    021-52887781
    Email
    xjhhsyy@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Non-inferiority Study of ZK-A03 in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient Manufacturer

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