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The goal of this clinical trail is to demonstrate the non-inferiority of recombinant human interferon α-2b gel (ZK-A03) after changing the manufacturer of the active ingredient in patients with herpes zoster.
This double-blind study will enroll approximately 368 adult patients with herpes zoster in China. Eligible patients will be assigned randomly at a 1:1 ratio.
For each patient who is included, treatment may last up to 10 days. During the study, subjects will be treated with recombinant human interferon α-2b gel (either before or after the alteration of the active ingredient manufacturer), at a frequency of four times a day, together with a background therapy of valaciclovir hydrochloride.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Human Interferon α-2b Gel (After the Alteration) | Experimental |
| |
| Recombinant Human Interferon α-2b Gel (Before the Alteration) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Interferon α-2b Gel (After the Alteration) | Drug | Recombinant human interferon α-2b gel (after the alteration of the active ingredient manufacturer) will be applied to the lesions as a thin layer, at the frequency of four times a day, together with the therapy of valaciclovir hydrochloride. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate at visit 4 (Day 7) | Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration. | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate at visit 3 (Day 4), and visit 5 (Day 11) | Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration. | 11 Days |
| Time to which new blisters stop appearing |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinghua Xu, MD | Contact | 021-52887781 | xjhhsyy@163.com |
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|
| Recombinant Human Interferon α-2b Gel (Before the Alteration) | Drug | Recombinant human interferon α-2b gel (before the alteration of the active ingredient manufacturer) will be applied to the lesions as a thin layer, at the frequency of four times a day, together with the therapy of valaciclovir hydrochloride. |
|
The time from the first day of medication (D1) to the cessation of new blisters.
| 11 Days |
| The time to beginning of crusting. | The time from the first day of medication (D1) to the beginning of crusting. | 11 Days |
| The time to which all blisters are crustosus. | The time from the first day of medication (D1) to the crustosus of all blisters. | 11 Days |
| The pain improvement rate at visit 4 (Day 7) | Pain change of ≥1 from baseline is considered as pain improvement. | 7 Days |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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