A Phase 4 interventional study of 2LHERP® and Placebo in Herpes Simplex, sponsored by Labo'Life. Recruiting at 6 sites in Belgium. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Labo'Life · Phase 4, Interventional, and Treatment
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.
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:
Treatment phase:
166 studies on the registry are indexed under Herpes Simplex; 12 are open to participants now.
This study's planned enrollment of 140 is above the median of 66 across 113 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →Labo'Life is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
(*) important renal or respiratory insufficiency, transplanted or grafted patients /AIDS, terminal cancer.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group N°1: 2LHERP® treatment (6 months of treatment)
Drug: 2LHERP®
Group N°1: Placebo treatment (6 months of treatment)
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.
Also known as: 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.
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 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.
Time frame: 12 months
Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no)
The objective of this outcome will be to compare the number of patients recurrence free for 12 months between the treated and the placebo group.
Time frame: 12 months
Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no)
The objective of this outcome will be to compare the number of patients recurrence free for 6 months after treatment initiation between the treated and the placebo group.
Time frame: 6 months
Number of episodes of herpes infection observed at 6 months
The objective of this outcome will be to compare the number of herpetic episodes at 6 months and the baseline number of episodes.
Time frame: 6 months
Time to first recurrence of herpes infection during the treatment
The objective of this outcome will be to compare the time to first herpetic recurrence between the treated and the placebo group.
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
The objective of this outcome will be to compare the mean duration of the herpetic episodes between the treated and the placebo group.
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
The objective of this outcome will be to compare the level of pain during herpetic episodes between the treated and the placebo group.
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
The objective of this outcome will be to compare the use of rescue medication during herpetic episodes between the treated and the placebo group.
Time frame: 12 months
Quality of life evaluated via a 6-items questionnaire
The objective of this outcome will be to compare the quality of life between the treated and the placebo group.
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
The objective of this outcome is to evaluate the safety of the treatment
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2020 (actual). Primary completion is estimated for Mar 2027, 84 months after the start.
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