Clinical trial NCT05492591: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Zoster
Keywords: Herpes zoster
peginterferon
efficacy
safety
postherpetic neuralgia
Lead sponsor: Shanghai Institute Of Biological Products
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, randomized, active drug-controlled, dose-finding phase II clinical study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time of stop increasing new blisters/pimples
timeFrame: 5 days after the first dose
measure: Time of target herpes begins to scab
timeFrame: 7 days after the first dose.
measure: Time of complete scabbing of all herpes
timeFrame: 10 days after the first dose.
Secondary outcomes:
measure: Changes in VAS scores on day 1 from baseline
timeFrame: 1 days after the first dose.
measure: Changes in VAS scores on day 2 from baseline
timeFrame: 2 days after the first dose.
measure: Changes in VAS scores on day 3 from baseline
timeFrame: 3 days after the first dose.
measure: Changes in VAS scores on day 4 from baseline
timeFrame: 4 days after the first dose.
measure: Changes in VAS scores on day 6 from baseline
timeFrame: 6 days after the first dose.
measure: Changes in VAS scores on day 10 from baseline
timeFrame: 10 days after the first dose.
measure: Changes in VAS scores on day 14 from baseline
timeFrame: 14 days after the first dose.
measure: Changes in VAS scores on day 21 from baseline
timeFrame: 21 days after the first dose.
measure: Changes in VAS scores on day 27 from baseline
timeFrame: 27 days after the first dose.
measure: Time that VAS score to drop to ≤2
timeFrame: 10 days after the first dose.
measure: Duration time that VAS score to drop to ≤2
timeFrame: 20 days after the first dose.
measure: The time that scabs of blisters fall off
timeFrame: 16 days after the first dose.
measure: Dose of painkiller
timeFrame: 16 days after the first dose.
measure: Incidence of postherpetic neuralgia
timeFrame: 105 days after the first dose.
Other outcomes:
measure: Postherpetic neuralgia duration
timeFrame: 105 days after the first dose.
Locations:
city: Nanjing
country: China
facility: Chinese Academy of Medical Sciences Dermatology Hospital
state: Jiangsu
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Qianjin Lu
role: PRINCIPAL_INVESTIGATOR
References: