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A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster

NCT ID: NCT05492591

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-11

Study Completion Date

2023-07-22

Brief Summary

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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

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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.

Conditions

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Herpes Zoster

Keywords

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Herpes zoster peginterferon efficacy safety postherpetic neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a multicenter, randomized, active drug-controlled, dose-finding phase II clinical study.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

Peginterferon α1b

Intervention Type DRUG

Injecting different doses of the peginterferon α1b into different groups of subjects.

Group 2

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

Group Type EXPERIMENTAL

Peginterferon α1b

Intervention Type DRUG

Injecting different doses of the peginterferon α1b into different groups of subjects.

Group 3

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

Group Type EXPERIMENTAL

Peginterferon α1b

Intervention Type DRUG

Injecting different doses of the peginterferon α1b into different groups of subjects.

Group 4

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

Group Type EXPERIMENTAL

Peginterferon α1b with valacyclovir

Intervention Type DRUG

Both valacyclovir tablets and different dose of peginterferon α1b plan to be used in different groups of subjects.

Group 5

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

Group Type EXPERIMENTAL

Peginterferon α1b with valacyclovir

Intervention Type DRUG

Both valacyclovir tablets and different dose of peginterferon α1b plan to be used in different groups of subjects.

Group 6

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

Group Type ACTIVE_COMPARATOR

Valacyclovir

Intervention Type DRUG

Valacyclovir is a positive control drug.

Interventions

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Peginterferon α1b

Injecting different doses of the peginterferon α1b into different groups of subjects.

Intervention Type DRUG

Peginterferon α1b with valacyclovir

Both valacyclovir tablets and different dose of peginterferon α1b plan to be used in different groups of subjects.

Intervention Type DRUG

Valacyclovir

Valacyclovir is a positive control drug.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Institute Of Biological Products

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qianjin Lu

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Locations

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Chinese Academy of Medical Sciences Dermatology Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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SIBP-R01

Identifier Type: -

Identifier Source: org_study_id