Study of 2LHERP® in Genital Herpes Infections (HEARTH-GEN)

Labo'Life

Status and phase: Terminated; Phase 4

Conditions: Herpes Simplex, Genital

Treatments: Drug: Placebo; Drug: 2LHERP®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04235322

LLB-2019-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 2 patient groups, including a placebo group

2LHERP® arm

Experimental group

Description:

2LHERP® treatment (6 months of treatment)

Treatment:

Drug: 2LHERP®

Placebo arm

Placebo Comparator group

Description:

Placebo treatment (6 months of treatment)

Treatment:

Drug: Placebo