A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster

December 24, 2023 updated by: Shanghai Institute Of Biological Products

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Chinese Academy of Medical Sciences Dermatology Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
5 μg/kg of peginterferon α1b for injection in patients with herpes zoster.
Drug: Peginterferon α1b
Injecting different doses of the peginterferon α1b into different groups of subjects.
Experimental: Group 2
6 μg/kg of peginterferon α1b for injection in patients with herpes zoster.
Drug: Peginterferon α1b
Injecting different doses of the peginterferon α1b into different groups of subjects.
Experimental: Group 3
7 μg/kg of peginterferon α1b for injection in patients with herpes zoster.
Drug: Peginterferon α1b
Injecting different doses of the peginterferon α1b into different groups of subjects.
Experimental: Group 4
Both valacyclovir tablets and 6 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster.
Drug: Peginterferon α1b with valacyclovir
Both valacyclovir tablets and different dose of peginterferon α1b plan to be used in different groups of subjects.
Experimental: Group 5
Both valacyclovir tablets and 7 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster.
Drug: Peginterferon α1b with valacyclovir
Both valacyclovir tablets and different dose of peginterferon α1b plan to be used in different groups of subjects.
Active Comparator: Group 6
Only valacyclovir tablets in patients with herpes zoster, positive drug control group.
Drug: Valacyclovir
Valacyclovir is a positive control drug.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time of stop increasing new blisters/pimples
Time Frame: 5 days after the first dose
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.
5 days after the first dose
Time of target herpes begins to scab
Time Frame: 7 days after the first dose.
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.
7 days after the first dose.
Time of complete scabbing of all herpes
Time Frame: 10 days after the first dose.
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.
10 days after the first dose.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in VAS scores on day 1 from baseline
Time Frame: 1 days after the first dose.
Changes in VAS scores of subjects on day 1 from baseline.
1 days after the first dose.
Changes in VAS scores on day 2 from baseline
Time Frame: 2 days after the first dose.
Changes in VAS scores of subjects on day 2 from baseline.
2 days after the first dose.
Changes in VAS scores on day 3 from baseline
Time Frame: 3 days after the first dose.
Changes in VAS scores of subjects on day 3 from baseline.
3 days after the first dose.
Changes in VAS scores on day 4 from baseline
Time Frame: 4 days after the first dose.
Changes in VAS scores of subjects on day 4 from baseline.
4 days after the first dose.
Changes in VAS scores on day 6 from baseline
Time Frame: 6 days after the first dose.
Changes in VAS scores of subjects on day 6 from baseline.
6 days after the first dose.
Changes in VAS scores on day 10 from baseline
Time Frame: 10 days after the first dose.
Changes in VAS scores of subjects on day 10 from baseline.
10 days after the first dose.
Changes in VAS scores on day 14 from baseline
Time Frame: 14 days after the first dose.
Changes in VAS scores of subjects on day 14 from baseline.
14 days after the first dose.
Changes in VAS scores on day 21 from baseline
Time Frame: 21 days after the first dose.
Changes in VAS scores of subjects on day 21 from baseline.
21 days after the first dose.
Changes in VAS scores on day 27 from baseline
Time Frame: 27 days after the first dose.
Changes in VAS scores of subjects on day 27 from baseline.
27 days after the first dose.
Time that VAS score to drop to ≤2
Time Frame: 10 days after the first dose.
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.
10 days after the first dose.
Duration time that VAS score to drop to ≤2
Time Frame: 20 days after the first dose.
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.
20 days after the first dose.
The time that scabs of blisters fall off
Time Frame: 16 days after the first dose.
The number of days it took for the scabs of all herpes to completely fall off after the subjects were screened into the group.
16 days after the first dose.
Dose of painkiller
Time Frame: 16 days after the first dose.
The dose of painkiller used within 27 days of the subject's first dose.
16 days after the first dose.
Incidence of postherpetic neuralgia
Time Frame: 105 days after the first dose.
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).
105 days after the first dose.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postherpetic neuralgia duration
Time Frame: 105 days after the first dose.
The duration of postherpetic neuralgia within 105 days after the subject's first dose.
105 days after the first dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Institute Of Biological Products

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chinese Academy of Medical Sciences Dermatology Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qianjin Lu, Chinese Academy of Medical Sciences Dermatology Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIBP-R01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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