A Phase 4 interventional study of 2LHERP® and Placebo in Herpes Simplex, Genital, sponsored by Labo'Life. Terminated at 13 sites in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
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 maximum 45 months with 33 months of inclusion and 12 months of follow-up. Patients aged between 18 and 80 years who present recurrent genital herpes infections (4 or more episodes within the 12-months' period prior to their study entry). The total number of patients to include will be 100 with 50 patients per group.
Primary objective:
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent genital herpes infections at 12 months compare to placebo.
Secondary objectives:
Comparison of the efficacy of 2LHERP® vs placebo, according to the following aspects:
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.
70 studies on the registry are indexed under Herpes Genitalis; 3 are open to participants now.
This study's enrollment of 6 is below the median of 103 across 51 interventional studies indexed under Herpes Genitalis.
Browse Herpes Genitalis 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.
2LHERP® treatment (6 months of treatment)
Drug: 2LHERP®
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 genital herpes infections at 12 months compare to placebo.
Change from baseline within the number of episodes of genital herpes infection 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
Comparison of the efficacy of 2LHERP® versus placebo according to the number of episodes at 6 months.
Number of episodes of herpes infections observed at month 6
Time frame: 6 months
Comparison of the efficacy of 2LHERP® versus placebo according to - remaining herpes infection recurrence free 6 and 12 months after the treatment initiation
Patient remaining herpes infection recurrence free 6 months and 12 months after the treatment initiation
Time frame: 6 and 12 months
Comparison of the efficacy of 2LHERP® versus placebo according to the time to first episode during the treatment
Time to first recurrence of herpes infection during the treatment
Time frame: 6 months
Comparison of the efficacy of 2LHERP® versus placebo according to the duration of episodes
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: 6 and 12 months
Comparison of the efficacy of 2LHERP® versus placebo according to the symptomatology during the entire relapse time
Level of pain recorded daily on a visual analogue scale (100mm), as well as other associated symptomatology for genital (genital lesions/craks, difficulties to urinate, genital pruritus/burn, fever, QoL), which will be consequently measured as area under the curve (AUC)
Time frame: 6 and 12 months
Comparison of the efficacy of 2LHERP® versus placebo according to the use of Rescue Medication
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: 6 and 12 months
Comparison of the efficacy of 2LHERP® versus placebo according to the evaluation of impact on the quality of life
6-items questionnaire of quality of life
Time frame: 6 and 12 months
Comparison of the efficacy of 2LHERP® versus placebo according to safety issues
Adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug
Time frame: 6 months
Plan to share: No
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This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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