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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Time of stop increasing new blisters/pimples
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group 1
5 μg/kg of peginterferon α1b for injection in patients with herpes zoster.
Intervention: Peginterferon α1b (Drug)
Group 2
6 μg/kg of peginterferon α1b for injection in patients with herpes zoster.
Intervention: Peginterferon α1b (Drug)
Group 3
7 μg/kg of peginterferon α1b for injection in patients with herpes zoster.
Intervention: Peginterferon α1b (Drug)
Group 4
Both valacyclovir tablets and 6 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster.
Intervention: Peginterferon α1b with valacyclovir (Drug)
Group 5
Both valacyclovir tablets and 7 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster.
Intervention: Peginterferon α1b with valacyclovir (Drug)
Group 6
Only valacyclovir tablets in patients with herpes zoster, positive drug control group.
Intervention: Valacyclovir (Drug)
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- 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.)
- Changes in VAS scores on day 10 from baseline(10 days after the first dose.)
- Changes in VAS scores on day 14 from baseline(14 days after the first dose.)
- Changes in VAS scores on day 21 from baseline(21 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 1 from baseline(1 days after the first dose.)
- Dose of painkiller(16 days after the first dose.)
- Incidence of postherpetic neuralgia(105 days after the first dose.)
- Changes in VAS scores on day 27 from baseline(27 days after the first dose.)
- Time that VAS score to drop to ≤2(10 days after the first dose.)
- Duration time that VAS score to drop to ≤2(20 days after the first dose.)
- The time that scabs of blisters fall off(16 days after the first dose.)