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
- 发起方
- 入组人数
- 140
- 试验地点
- 9
- 主要终点
- Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months.
研究概览
简要总结
Herpes simplex virus (HSV) infection is very common, as most people will experience herpetic infection during their lifetime. The most common manifestation of HSV infection is sores which may appear at any age.
No specific antiviral therapy is available to totally cure herpetic infections and today, there is no treatment that allows the definitive eradication of the virus.
The 2LHERP® has been available for more than 20 years, and has received a marketing authorization in Belgium by the FAMHP. It is used as an immune regulator in the treatment of herpetic infections. Since 2LHERP® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the disappearance of herpetic recurrences.
The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LHERP® on the treatment of herpetic infections in adults.
详细描述
The study duration will be 36 months with 24 months of inclusion (that may be extended if the expected number of patients is not reached after this period) and 12 months of follow-up.
Patients aged between 16 and 80 years who present recurrent orofacial herpes infections (6 or more episodes within the 12-months' period prior to their study entry).
The total number of patients to include will be 140 with 70 patients per group.
Primary objective:
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
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 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 micro-immunotherapy 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,
- •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.
研究组 & 干预措施
2LHERP® arm
Group N°1: 2LHERP® treatment (6 months of treatment)
干预措施: 2LHERP® (Drug)
Placebo arm
Group N°1: Placebo treatment (6 months of treatment)
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months.
时间窗: 12 months
The primary objective of the study will be to evaluate the 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
- Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no)(12 months)
- Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no)(6 months)
- Number of episodes of herpes infection observed at 6 months(6 months)
- Time to first recurrence of herpes infection during the treatment(6 months)
- Mean duration of episodes, the duration for a given episode being defined as the number of days between the start of the episode and the last day before all symptoms recorded as 'none' for 2 consecutive days, in the patient diary(12 months)
- Level of pain recorded daily as well as other associated symptomatology for orofacial pain, which will be consequently measured as area under the curve(12 months)
- Use of daily rescue medicine (RM), expressed with the cumulative number of days for the treatment period, the follow-up period and the entire study period(12 months)
- Quality of life evaluated via a 6-items questionnaire(6 and 12 months)
- Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug(6 months)