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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 368
- 主要终点
- Clinical cure rate at visit 4 (Day 7)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 18 and 70 years old.
- •Diagnosed as herpes zoster.
- •Time to appearance of lesions ≤ 72 hours prior to the first dosing (lesions may represent as: erythema, papules or blisters), lesion area ≤ 3% body surface area (BSA).
- •Self-rated Numerical Rating Scale (NRS) in pain ≤
- •Negative serum pregnancy test for women of reproductive age. Birth control from first dosing until 1 month after last dosing for all men and women of reproductive age.
- •Subjects must have signed an informed consent form (ICF).
排除标准
- •Diagnosed as herpes zoster on face, visceral herpes zoster, herpes zoster meningitis, disseminated herpes zoster, zoster sine herpete or blood blisters and necrosis.
- •The lesion is complicated with other skin diseases that may affect the evaluation of efficacy,
- •Skin lesions combined with severe bacterial or fungal infections.
- •Use of antiviral or analgesic therapy for herpes zoster within 2 weeks prior to the first dosing.
- •Known allergies to recombinant human interferon α-2b and chemical structure analogs, valaciclovir or history of any drug, food or other allergy.
- •Liver and/or renal disfunction，ie. Alanine aminotransferase (ALT), Aspartate transaminase (AST) > 2 times of upper normal limit（ULN）; Creatinine Clearance Rate (CCR) < 50 L/min.
- •Combined with immunodeficiency disease or require long-term glucocorticoid or immunosuppressive drugs.
- •Combined with severe cardiovascular, respiratory, gastrointestinal or neurological disorders and remains unstable after treatment.
- •History of psychiatric illness or inability to fully comply to the protocol.
- •Use of another investigational product within 4 weeks prior to the first dosing.
- •Pregnant or lactating women.
- •Other conditions deemed by the investigator to be inappropriate for participation in this trial.
研究组 & 干预措施
Recombinant Human Interferon α-2b Gel (After the Alteration)
干预措施: Recombinant Human Interferon α-2b Gel (After the Alteration) (Drug)
Recombinant Human Interferon α-2b Gel (Before the Alteration)
干预措施: Recombinant Human Interferon α-2b Gel (Before the Alteration) (Drug)
结局指标
主要结局
Clinical cure rate at visit 4 (Day 7)
时间窗: 7 Days
Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration.
次要结局
- The time to beginning of crusting.(11 Days)
- The time to which all blisters are crustosus.(11 Days)
- The pain improvement rate at visit 4 (Day 7)(7 Days)
- Clinical cure rate at visit 3 (Day 4), and visit 5 (Day 11)(11 Days)
- Time to which new blisters stop appearing(11 Days)