Trials / Unknown
UnknownNCT05806918
Non-inferiority Study of ZK-A03 in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient Manufacturer
A Multicenter, Randomized, Double-blind, Controlled, Non-inferiority Phase III Clinical Trial of Recombinant Human Interferon Alpha-2b Gel (ZK-A03) in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient Manufacturer
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 368 (estimated)
- Sponsor
- Lee's Pharmaceutical Limited · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Human Interferon α-2b Gel (After the Alteration) | 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. |
| DRUG | Recombinant Human Interferon α-2b Gel (Before the Alteration) | 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. |
Timeline
- Start date
- 2023-04-01
- Primary completion
- 2023-07-30
- Completion
- 2023-08-30
- First posted
- 2023-04-10
- Last updated
- 2023-04-10
Source: ClinicalTrials.gov record NCT05806918. Inclusion in this directory is not an endorsement.