Clinical trial NCT04235322: Study of 2LHERP® in Genital Herpes Infections
Official title: Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Genital Herpes Infections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Herpes Simplex, Genital
Lead sponsor: Labo'Life
Sponsor class: INDUSTRY
First posted: 2020-01-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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:

* number of episodes at 6 months,
* remaining herpes infection recurrence free 6 and 12 months after the treatment initiation,
* time to first episode during the treatment,
* duration of episodes,
* symptomatology during the entire relapse time,
* use of Rescue Medication (RM),
* evaluation of impact on the quality of life,
* 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.

Eligibility criteria: Inclusion Criteria:

* Man or woman aged 18-80 years,
* Patient presenting 4 or more episodes of genital 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.

Primary outcomes:
measure: Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent genital herpes infections at 12 months compare to placebo.
timeFrame: 12 months
Secondary outcomes:
measure: Comparison of the efficacy of 2LHERP® versus placebo according to the number of episodes at 6 months.
timeFrame: 6 months
measure: Comparison of the efficacy of 2LHERP® versus placebo according to - remaining herpes infection recurrence free 6 and 12 months after the treatment initiation
timeFrame: 6 and 12 months
measure: Comparison of the efficacy of 2LHERP® versus placebo according to the time to first episode during the treatment
timeFrame: 6 months
measure: Comparison of the efficacy of 2LHERP® versus placebo according to the duration of episodes
timeFrame: 6 and 12 months
measure: Comparison of the efficacy of 2LHERP® versus placebo according to the symptomatology during the entire relapse time
timeFrame: 6 and 12 months
measure: Comparison of the efficacy of 2LHERP® versus placebo according to the use of Rescue Medication
timeFrame: 6 and 12 months
measure: Comparison of the efficacy of 2LHERP® versus placebo according to the evaluation of impact on the quality of life
timeFrame: 6 and 12 months
measure: Comparison of the efficacy of 2LHERP® versus placebo according to safety issues
timeFrame: 6 months
Other outcomes:
Locations:
city: Lodelinsart
country: Belgium
facility: Private practice
state: Charleroi
city: Andenne
country: Belgium
facility: Polyclinique D'Andenne
city: Bruxelles
country: Belgium
facility: Dr MANOUACH Fatiha
city: Bruxelles
country: Belgium
facility: Dr VERHEVEN Cécile
city: Bruxelles
country: Belgium
facility: Private Practice
city: Charleroi
country: Belgium
facility: CHU Charleroi - Hopital Marie Curie
city: Gozée
country: Belgium
facility: Cabinet privé
city: Huy
country: Belgium
facility: Centre Hospitalier Regional de Huy
city: Libramont
country: Belgium
facility: Private Practice
city: Libramont
country: Belgium
facility: Vivalia - Centre Hospitalier de L'Ardenne - Libramont Chevigny
city: Nivelles
country: Belgium
facility: Dr PETTEAU Myriam
city: Noirefontaine
country: Belgium
facility: Dr ROULEFF Denis
city: Oisquercq
country: Belgium
facility: Private Practice
Study officials:
References: