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A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster

Primary Purpose

Herpes Zoster

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Peginterferon α1b
Peginterferon α1b with valacyclovir
Valacyclovir
Sponsored by
Shanghai Institute Of Biological Products
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Zoster focused on measuring Herpes zoster, peginterferon, efficacy, safety, postherpetic neuralgia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must give informed consent to the study and agree to participate and give written consent before the study;
  • 18 Years to 75 Years (Including 18 and 75 years old),Male or Female;
  • Pain VAS score≥3;
  • Patients with clinical diagnosis of Herpes Zoster,According to the Chinese Expert Consensus on Herpes zoster (2018) (the rash was asymmetric, unilateral erythematous or maculopapular rash, or clusters of small blisters could appear, and the blister fluid was clear or became cloudy), the appearance of herpes zoster was determined within 3 days (72 hours).

Exclusion Criteria:

  • Allergic constitution or history of allergy or known allergy to the test drug product or any component;
  • Clinically diagnosed as herpes zoster without rash, disseminated herpes zoster; ear herpes zoster; ocular herpes zoster; with symptoms of viral encephalitis and meningitis; with symptoms of acute gastroenteritis and cystitis; Herpes zoster patients with hemorrhagic, gangrenous clinical manifestations, etc;
  • Herpes site with neuralgia caused by other diseases;
  • History of serious heart disease, including unstable or uncontrolled angina within 6 months, history of myocardial infarction and other heart disease, epilepsy and other central nervous system disorders, history of autoimmune hepatitis or autoimmune disease, severe liver function Impaired or decompensated cirrhosis, severe mental illness or medical history;
  • During the screening period, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 fold ULN;Platelet count <90×109/L;Hemoglobin: male<110g/L,female<100g/L;White blood cell count <3.5×109/L、neutrophil count <1.5×109/L;Renal insufficiency(Cr>1.5 fold ULN and creatinine clearance <60 mL/min),abnormal thyroid function test, positive hepatitis B surface antigen, positive hepatitis C antibody, positive treponema pallidum antibody or positive HIV antibody test in serum virology;
  • Previous history of psoriasis;
  • Previous organ transplant recipients;
  • Patients with active hemorrhagic disease, or severe hematopoietic abnormalities or coagulation disorders within 2 weeks prior to screening;
  • Patients with previous history of malignant tumor;
  • Patients with a history of severe retinal disease;
  • Have received live attenuated vaccine (hepatitis B vaccine, pneumonia vaccine, tetanus vaccine, rabies virus vaccine, cervical cancer vaccine, etc.) within 3 months before screening or planned to receive live attenuated vaccine (hepatitis B vaccine, pneumonia vaccine, tetanus vaccine, rabies virus vaccine, cervical cancer vaccine, etc.) during the trial; have received COVID-19 vaccine within 2 weeks before screening or planned to receive COVID-19 vaccine during the trial;
  • Lactating women, blood pregnancy positive subjects (female subjects only), male subjects (or their partners) or female subjects had pregnancy plans or sperm or egg donation plans from 30 days before the study to 3 months after the end of the study and were unwilling to take effective contraceptive measures;
  • Participated in any drug or device clinical investigator within 3 months prior to screening;
  • Need for driving or precision instrument operation during the study period;
  • Within 1 month or 5 half-lives (whichever is the longest) before screening, drugs with therapeutic effect on herpes zoster have been systematically used: interferon, antiviral drugs, immune modulators, glucocorticoids, traditional Chinese medicine/patent medicine, neurotrophic drugs, drugs containing theophylline, etc;
  • The patients who had been treated with topical drugs for herpes zoster within 2 weeks before the screening were selected;
  • The investigators considered it inappropriate to participate in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Group 3

    Group 4

    Group 5

    Group 6

    Arm Description

    5 μg/kg of peginterferon α1b for injection in patients with herpes zoster.

    6 μg/kg of peginterferon α1b for injection in patients with herpes zoster.

    7 μg/kg of peginterferon α1b for injection in patients with herpes zoster.

    Both valacyclovir tablets and 6 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster.

    Both valacyclovir tablets and 7 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster.

    Only valacyclovir tablets in patients with herpes zoster, positive drug control group.

    Outcomes

    Primary Outcome Measures

    Time of stop increasing new blisters/pimples
    The number of days it took for the herpes to stop increasing (the original blisters/pimples enlarge, and the blisters/pimples increase) after the subjects were screened and enrolled.
    Time of target herpes begins to scab
    The time taken for the target herpes (where the herpes first occurred when the patient was enrolled) begin to scab after the subjects were screened for enrollment.
    Time of complete scabbing of all herpes
    The time taken for all the herpes to be completely crusted (the blisters have dried up and crusted) after the subjects were screened and enrolled.

    Secondary Outcome Measures

    Changes in VAS scores on day 1 from baseline
    Changes in VAS scores of subjects on day 1 from baseline.
    Changes in VAS scores on day 2 from baseline
    Changes in VAS scores of subjects on day 2 from baseline.
    Changes in VAS scores on day 3 from baseline
    Changes in VAS scores of subjects on day 3 from baseline.
    Changes in VAS scores on day 4 from baseline
    Changes in VAS scores of subjects on day 4 from baseline.
    Changes in VAS scores on day 6 from baseline
    Changes in VAS scores of subjects on day 6 from baseline.
    Changes in VAS scores on day 10 from baseline
    Changes in VAS scores of subjects on day 10 from baseline.
    Changes in VAS scores on day 14 from baseline
    Changes in VAS scores of subjects on day 14 from baseline.
    Changes in VAS scores on day 21 from baseline
    Changes in VAS scores of subjects on day 21 from baseline.
    Changes in VAS scores on day 27 from baseline
    Changes in VAS scores of subjects on day 27 from baseline.
    Time that VAS score to drop to ≤2
    The time taken for the VAS score to decrease from baseline ≥3 to ≤2 for the first time after the subjects were screened and enrolled.
    Duration time that VAS score to drop to ≤2
    After the subject's VAS score dropped from baseline ≥ 3 to ≤ 2 for the first time, the time that the VAS score remained at ≤ 2.
    The time that scabs of blisters fall off
    The number of days it took for the scabs of all herpes to completely fall off after the subjects were screened into the group.
    Dose of painkiller
    The dose of painkiller used within 27 days of the subject's first dose.
    Incidence of postherpetic neuralgia
    The incidence of hereditary neuralgia within 105 days after the first dose of the subjects. Postherpetic neuralgia is defined as pain lasting one month or more after the rash has healed (ie, complete exfoliation).

    Full Information

    First Posted
    August 5, 2022
    Last Updated
    August 5, 2022
    Sponsor
    Shanghai Institute Of Biological Products
    Collaborators
    Chinese Academy of Medical Sciences Dermatology Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05492591
    Brief Title
    A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster
    Official Title
    A Multicenter, Randomized, Active-controlled, Dose-finding Phase II Clinical Study Evaluating the Safety and Efficacy of Peginterferon α1b for Injection in Patients With Herpes Zoster
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 15, 2022 (Anticipated)
    Primary Completion Date
    March 30, 2023 (Anticipated)
    Study Completion Date
    July 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Institute Of Biological Products
    Collaborators
    Chinese Academy of Medical Sciences Dermatology Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    This trial is a multicenter, randomized, active drug-controlled, dose-finding phase II clinical study. A total of 5 experimental groups and 1 positive drug control group were set up 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Herpes Zoster
    Keywords
    Herpes zoster, peginterferon, efficacy, safety, postherpetic neuralgia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a multicenter, randomized, active drug-controlled, dose-finding phase II clinical study.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    5 μg/kg of peginterferon α1b for injection in patients with herpes zoster.
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    6 μg/kg of peginterferon α1b for injection in patients with herpes zoster.
    Arm Title
    Group 3
    Arm Type
    Experimental
    Arm Description
    7 μg/kg of peginterferon α1b for injection in patients with herpes zoster.
    Arm Title
    Group 4
    Arm Type
    Experimental
    Arm Description
    Both valacyclovir tablets and 6 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster.
    Arm Title
    Group 5
    Arm Type
    Experimental
    Arm Description
    Both valacyclovir tablets and 7 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster.
    Arm Title
    Group 6
    Arm Type
    Active Comparator
    Arm Description
    Only valacyclovir tablets in patients with herpes zoster, positive drug control group.
    Intervention Type
    Drug
    Intervention Name(s)
    Peginterferon α1b
    Intervention Description
    Injecting different doses of the peginterferon α1b into different groups of subjects.
    Intervention Type
    Drug
    Intervention Name(s)
    Peginterferon α1b with valacyclovir
    Intervention Description
    Both valacyclovir tablets and different dose of peginterferon α1b plan to be used in different groups of subjects.
    Intervention Type
    Drug
    Intervention Name(s)
    Valacyclovir
    Intervention Description
    Valacyclovir is a positive control drug.
    Primary Outcome Measure Information:
    Title
    Time of stop increasing new blisters/pimples
    Description
    The number of days it took for the herpes to stop increasing (the original blisters/pimples enlarge, and the blisters/pimples increase) after the subjects were screened and enrolled.
    Time Frame
    5 days after the first dose
    Title
    Time of target herpes begins to scab
    Description
    The time taken for the target herpes (where the herpes first occurred when the patient was enrolled) begin to scab after the subjects were screened for enrollment.
    Time Frame
    7 days after the first dose.
    Title
    Time of complete scabbing of all herpes
    Description
    The time taken for all the herpes to be completely crusted (the blisters have dried up and crusted) after the subjects were screened and enrolled.
    Time Frame
    10 days after the first dose.
    Secondary Outcome Measure Information:
    Title
    Changes in VAS scores on day 1 from baseline
    Description
    Changes in VAS scores of subjects on day 1 from baseline.
    Time Frame
    1 days after the first dose.
    Title
    Changes in VAS scores on day 2 from baseline
    Description
    Changes in VAS scores of subjects on day 2 from baseline.
    Time Frame
    2 days after the first dose.
    Title
    Changes in VAS scores on day 3 from baseline
    Description
    Changes in VAS scores of subjects on day 3 from baseline.
    Time Frame
    3 days after the first dose.
    Title
    Changes in VAS scores on day 4 from baseline
    Description
    Changes in VAS scores of subjects on day 4 from baseline.
    Time Frame
    4 days after the first dose.
    Title
    Changes in VAS scores on day 6 from baseline
    Description
    Changes in VAS scores of subjects on day 6 from baseline.
    Time Frame
    6 days after the first dose.
    Title
    Changes in VAS scores on day 10 from baseline
    Description
    Changes in VAS scores of subjects on day 10 from baseline.
    Time Frame
    10 days after the first dose.
    Title
    Changes in VAS scores on day 14 from baseline
    Description
    Changes in VAS scores of subjects on day 14 from baseline.
    Time Frame
    14 days after the first dose.
    Title
    Changes in VAS scores on day 21 from baseline
    Description
    Changes in VAS scores of subjects on day 21 from baseline.
    Time Frame
    21 days after the first dose.
    Title
    Changes in VAS scores on day 27 from baseline
    Description
    Changes in VAS scores of subjects on day 27 from baseline.
    Time Frame
    27 days after the first dose.
    Title
    Time that VAS score to drop to ≤2
    Description
    The time taken for the VAS score to decrease from baseline ≥3 to ≤2 for the first time after the subjects were screened and enrolled.
    Time Frame
    10 days after the first dose.
    Title
    Duration time that VAS score to drop to ≤2
    Description
    After the subject's VAS score dropped from baseline ≥ 3 to ≤ 2 for the first time, the time that the VAS score remained at ≤ 2.
    Time Frame
    20 days after the first dose.
    Title
    The time that scabs of blisters fall off
    Description
    The number of days it took for the scabs of all herpes to completely fall off after the subjects were screened into the group.
    Time Frame
    16 days after the first dose.
    Title
    Dose of painkiller
    Description
    The dose of painkiller used within 27 days of the subject's first dose.
    Time Frame
    16 days after the first dose.
    Title
    Incidence of postherpetic neuralgia
    Description
    The incidence of hereditary neuralgia within 105 days after the first dose of the subjects. Postherpetic neuralgia is defined as pain lasting one month or more after the rash has healed (ie, complete exfoliation).
    Time Frame
    105 days after the first dose.
    Other Pre-specified Outcome Measures:
    Title
    Postherpetic neuralgia duration
    Description
    The duration of postherpetic neuralgia within 105 days after the subject's first dose.
    Time Frame
    105 days after the first dose.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects must give informed consent to the study and agree to participate and give written consent before the study; 18 Years to 75 Years (Including 18 and 75 years old),Male or Female; Pain VAS score≥3; Patients with clinical diagnosis of Herpes Zoster,According to the Chinese Expert Consensus on Herpes zoster (2018) (the rash was asymmetric, unilateral erythematous or maculopapular rash, or clusters of small blisters could appear, and the blister fluid was clear or became cloudy), the appearance of herpes zoster was determined within 3 days (72 hours). Exclusion Criteria: Allergic constitution or history of allergy or known allergy to the test drug product or any component; Clinically diagnosed as herpes zoster without rash, disseminated herpes zoster; ear herpes zoster; ocular herpes zoster; with symptoms of viral encephalitis and meningitis; with symptoms of acute gastroenteritis and cystitis; Herpes zoster patients with hemorrhagic, gangrenous clinical manifestations, etc; Herpes site with neuralgia caused by other diseases; History of serious heart disease, including unstable or uncontrolled angina within 6 months, history of myocardial infarction and other heart disease, epilepsy and other central nervous system disorders, history of autoimmune hepatitis or autoimmune disease, severe liver function Impaired or decompensated cirrhosis, severe mental illness or medical history; During the screening period, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 fold ULN;Platelet count <90×109/L;Hemoglobin: male<110g/L,female<100g/L;White blood cell count <3.5×109/L、neutrophil count <1.5×109/L;Renal insufficiency(Cr>1.5 fold ULN and creatinine clearance <60 mL/min),abnormal thyroid function test, positive hepatitis B surface antigen, positive hepatitis C antibody, positive treponema pallidum antibody or positive HIV antibody test in serum virology; Previous history of psoriasis; Previous organ transplant recipients; Patients with active hemorrhagic disease, or severe hematopoietic abnormalities or coagulation disorders within 2 weeks prior to screening; Patients with previous history of malignant tumor; Patients with a history of severe retinal disease; Have received live attenuated vaccine (hepatitis B vaccine, pneumonia vaccine, tetanus vaccine, rabies virus vaccine, cervical cancer vaccine, etc.) within 3 months before screening or planned to receive live attenuated vaccine (hepatitis B vaccine, pneumonia vaccine, tetanus vaccine, rabies virus vaccine, cervical cancer vaccine, etc.) during the trial; have received COVID-19 vaccine within 2 weeks before screening or planned to receive COVID-19 vaccine during the trial; Lactating women, blood pregnancy positive subjects (female subjects only), male subjects (or their partners) or female subjects had pregnancy plans or sperm or egg donation plans from 30 days before the study to 3 months after the end of the study and were unwilling to take effective contraceptive measures; Participated in any drug or device clinical investigator within 3 months prior to screening; Need for driving or precision instrument operation during the study period; Within 1 month or 5 half-lives (whichever is the longest) before screening, drugs with therapeutic effect on herpes zoster have been systematically used: interferon, antiviral drugs, immune modulators, glucocorticoids, traditional Chinese medicine/patent medicine, neurotrophic drugs, drugs containing theophylline, etc; The patients who had been treated with topical drugs for herpes zoster within 2 weeks before the screening were selected; The investigators considered it inappropriate to participate in this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dandan Chen, Master
    Phone
    86-021-62800991
    Email
    ddchen.sh@sinopharm.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yan Chu
    Phone
    86-021-62800991
    Email
    chuyan1@sinopharm.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Qianjin Lu
    Organizational Affiliation
    Chinese Academy of Medical Sciences Dermatology Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster

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