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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 5 μg/kg of peginterferon α1b for injection in patients with herpes zoster. |
|
| Group 2 | Experimental | 6 μg/kg of peginterferon α1b for injection in patients with herpes zoster. |
|
| Group 3 | Experimental | 7 μg/kg of peginterferon α1b for injection in patients with herpes zoster. |
|
| Group 4 | Experimental | Both valacyclovir tablets and 6 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster. |
|
| Group 5 | Experimental | Both valacyclovir tablets and 7 μg/kg of peginterferon α1b for injection plan to be used in patients with herpes zoster. |
|
| Group 6 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon α1b | Drug | Injecting different doses of the peginterferon α1b into different groups of subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in VAS scores on day 1 from baseline | 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 | Changes in VAS scores of subjects on day 2 from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Postherpetic neuralgia duration | The duration of postherpetic neuralgia within 105 days after the subject's first dose. | 105 days after the first dose. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qianjin Lu | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences Dermatology Hospital | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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This is a multicenter, randomized, active drug-controlled, dose-finding phase II clinical study.
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Only valacyclovir tablets in patients with herpes zoster, positive drug control group. |
|
| Peginterferon α1b with valacyclovir | Drug | Both valacyclovir tablets and different dose of peginterferon α1b plan to be used in different groups of subjects. |
|
| Valacyclovir | Drug | Valacyclovir is a positive control drug. |
|
| 2 days after the first dose. |
| Changes in VAS scores on day 3 from baseline | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | The dose of painkiller used within 27 days of the subject's first dose. | 16 days after the first dose. |
| Incidence of postherpetic neuralgia | 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. |
| D007239 | Infections |
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |