A Study Exploring Efficacy of Peginterferon in Patients With Herpes Zoster

NCT05492591 | Completed Phase 2 DMC

• 1 other identifier: SIBP-R01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Zoster

Keywords

Herpes zoster; peginterferon; efficacy; safety; postherpetic neuralgia

Outcome Measures

Primary Outcomes (3)

• 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.

  5 days after the first dose

• 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.

  7 days after the first dose.

• 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.

  10 days after the first dose.

Secondary Outcomes (14)

• Changes in VAS scores on day 1 from baseline

  1 days after the first dose.

• Changes in VAS scores on day 2 from baseline

  2 days after the first dose.

• Changes in VAS scores on day 3 from baseline

  3 days after the first dose.

• Changes in VAS scores on day 4 from baseline

  4 days after the first dose.

• Changes in VAS scores on day 6 from baseline

  6 days after the first dose.

Other Outcomes (1)

• Postherpetic neuralgia duration

  105 days after the first dose.

Study Arms (6)

Group 1

EXPERIMENTAL

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

Drug: Peginterferon α1b

Group 2

EXPERIMENTAL

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

Drug: Peginterferon α1b

Group 3

EXPERIMENTAL

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

Drug: Peginterferon α1b

Group 4

EXPERIMENTAL

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

Group 5

EXPERIMENTAL

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

Group 6

ACTIVE COMPARATOR

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

Drug: Valacyclovir

Interventions

Peginterferon α1b DRUG

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

Group 1; Group 2; Group 3

Peginterferon α1b with valacyclovir DRUG

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

Group 4; Group 5

Valacyclovir DRUG

Valacyclovir is a positive control drug.

Group 6

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must give informed consent to the study and agree to participate and give written consent before the study;
• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Chinese Academy of Medical Sciences Dermatology Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Qianjin Lu

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized, active drug-controlled, dose-finding phase II clinical study.

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 8, 2022
• Study Start: October 11, 2022
• Primary Completion: July 22, 2023
• Study Completion: July 22, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)