2024-514358-56-00招募中4 期
Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LHERP® in patients with recurrent orofacial herpes infections.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Change from baseline within the number of episodes of herpes infections observed for 12 months, where the baseline value is the number of episodes experienced within the 12 months preceeding study enrolment.
研究概览
简要总结
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Man or woman aged 16-80 years, - Patient presenting 6 or more episodes of orofacial herpes infections during the preceding 12-months’ period (prior to the study entry), - Woman of childbearing age under effective contraception, - Patient reporting a current stable sexual relationship (steady sexual partner during study duration), - Patient having faculties to understand and respect the constraints of the study, - Signature of the Informed Consent Form.
排除标准
- •Pregnant or breastfeeding woman, - Patient under immunotherapy (including immunosuppressive treatment) or microimmunotherapy received during last previous 6 months, - Patient who had a suppressive antiviral therapy during last month, - Patient who wishes to continue his/her suppressive antiviral therapy, - Patient with known lactose intolerance, galactose intolerance, lactase Lapp deficiency or glucose-galactose malabsorption syndrome - Patient who participated in a clinical study in the previous 3-month period, - Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study, - Patient with severe immunodeficiency disease requiring long term treatment (*) or under chemotherapy or radiotherapy or corticoid therapy, - Patient under listed homeopathic or phytotherapy treatment, - Patient using or addicted to recreational drugs. (*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.
结局指标
主要结局
Change from baseline within the number of episodes of herpes infections observed for 12 months, where the baseline value is the number of episodes experienced within the 12 months preceeding study enrolment.
Change from baseline within the number of episodes of herpes infections observed for 12 months, where the baseline value is the number of episodes experienced within the 12 months preceeding study enrolment.
次要结局
- a.1) Remaining herpes infection recurrence free 12 months after treatment initiation, a.2) Remaining herpes infection recurrence free 6 months after treatment initiation, a.3) Number of episodes of herpes infection observed at 6 months, b) Time to first recurrence of herpes infection during the treatment, c) Mean duration of episodes, d) Level of pain during episodes, e) Use of Rescue Medication, f) Quality of Life, e) Occurrence of AEs and SAEs
研究者
Laura Ferté Clinical Project Manager
Scientific
Labo'Life Belgium
研究点 (6)
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