drugset / Trial / NCT04235322

Study of 2LHERP® in Genital Herpes Infections

NCT04235322 ↗

Phase 4 Terminated 6 enrolled Labo'Life
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-01-25
Primary completion
2023-04-18
Completion
2023-04-18

Outcome

Outcome not reported

Stopped (Enrollment): “Labo'life decided to end prematurely HEARTH-GEN study from April 18th 2023 due to very low recruitment rates (6/100). Labo'life decided to focus all its efforts on another study using 2LHERP® in herpes treatment, called HEARTH-OF (NCT04065971)”

Drugs

EvaluationDrugModalityDoseRoute
Subject 2LHERP® Unknown — Oral

Indications