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

Herpes Simplex Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Herpes Simplex
• Herpesviridae Infections

• NCT number: NCT04065971
• Study type: Interventional
• Source: Labo'Life
• Contact: Laura FERTE
• Phone: 499 71 79 64
• Email: laura.ferte@labolife.com
• Status: Recruiting
• Phase: Phase 4
• Start date: March 10, 2020
• Completion date: June 30, 2024