Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 2LHERP®, Placebo.
- Who it may be relevant to
- Registry conditions: Herpes Simplex. Basic parameters: 16 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Orofacial Herpes Infections.
Overview
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.
Detailed description
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.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months. [Time frame: 12 months]
Secondary outcome measures (9)
- Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no) [Time frame: 12 months]
- Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no) [Time frame: 6 months]
- Number of episodes of herpes infection observed at 6 months [Time frame: 6 months]
- Time to first recurrence of herpes infection during the treatment [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 12 months]
- Quality of life evaluated via a 6-items questionnaire [Time frame: 6 and 12 months]
- Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Belgium · 6 centers
- Private Practice — Beerzel
- Cabinet privé — Beuzet
- Clinique Saint-Luc (Bouge) — Bouge
- Private Practice — Linkebeek
- Cabinet privé — Noirefontaine
- Private Practice — Oisquercq
Identifiers
NCT: NCT04065971 · LLB-2018-01