Study of 2LHERP® in Genital Herpes Infections

NCT ID: NCT04235322

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2023-04-18

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.

Conditions

Herpes Simplex, Genital

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

2LHERP® arm

2LHERP® treatment (6 months of treatment)

Group Type: EXPERIMENTAL

2LHERP®

Intervention Type: DRUG

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.

Placebo arm

Placebo treatment (6 months of treatment)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

2LHERP

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Labo'Life

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Private practice

Lodelinsart, Charleroi, Belgium

Polyclinique D'Andenne

Andenne, , Belgium

Dr MANOUACH Fatiha

Brussels, , Belgium

Dr VERHEVEN Cécile

Brussels, , Belgium

Private Practice

Brussels, , Belgium

CHU Charleroi - Hopital Marie Curie

Charleroi, , Belgium

Cabinet privé

Gozée, , Belgium

Centre Hospitalier Regional de Huy

Huy, , Belgium

Private Practice

Libramont, , Belgium

Vivalia - Centre Hospitalier de L'Ardenne - Libramont Chevigny

Libramont, , Belgium

Dr PETTEAU Myriam

Nivelles, , Belgium

Dr ROULEFF Denis

Noirefontaine, , Belgium

Private Practice

Oisquercq, , Belgium

Countries

Belgium

Other Identifiers

LLB-2019-01

Identifier Type: -

Identifier Source: org_study_id