Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.

Официальное название

Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Orofacial Herpes Infections.

Обзор

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.

Подробное описание

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.

Secondary objectives:

Comparison of the efficacy of 2LHERP® vs placebo according to the following aspects:

1. number of episodes at 6 months, 2. time to first episode during the treatment, 3. duration of episodes, 4. symptomatology during the entire relapse time, 5. use of Rescue Medication (RM), 6. evaluation of impact on the quality of life, 7. safety issues.

Treatment phase:

* Group n°1 = 2LHERP® (6 months of treatment) * Group n°2 = Placebo (6 months of treatment) Post-treatment follow-up phase: 6 months. Treatment will be considered successful if the number of herpetic episodes is reduced.

Вмешательства

• Препарат 2LHERP®
  The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.
• Препарат Placebo
  The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.

Первичные конечные точки

• Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months. [Срок оценки: 12 months]

Вторичные конечные точки (9)

• Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no) [Срок оценки: 12 months]
• Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no) [Срок оценки: 6 months]
• Number of episodes of herpes infection observed at 6 months [Срок оценки: 6 months]
• Time to first recurrence of herpes infection during the treatment [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 12 months]
• Quality of life evaluated via a 6-items questionnaire [Срок оценки: 6 and 12 months]
• Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 6 центров

• Private Practice — Beerzel
• Cabinet privé — Beuzet
• Clinique Saint-Luc (Bouge) — Bouge
• Private Practice — Linkebeek
• Cabinet privé — Noirefontaine
• Private Practice — Oisquercq

Идентификаторы

NCT: NCT04065971 · LLB-2018-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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