Study of 2LHERP® in Genital Herpes Infections

NCT04235322 | Terminated Phase 4

• 1 other identifier: LLB-2019-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 13

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.

Conditions

Herpes Simplex, Genital

Outcome Measures

Primary Outcomes (1)

• Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent genital herpes infections at 12 months compare to placebo.

  Change from baseline within the number of episodes of genital herpes infection observed for 12 months, where the baseline value is the number of episodes experienced within the 12 months preceeding study enrolment.

  12 months

Secondary Outcomes (8)

• Comparison of the efficacy of 2LHERP® versus placebo according to the number of episodes at 6 months.

  6 months

• Comparison of the efficacy of 2LHERP® versus placebo according to - remaining herpes infection recurrence free 6 and 12 months after the treatment initiation

  6 and 12 months

• Comparison of the efficacy of 2LHERP® versus placebo according to the time to first episode during the treatment

  6 months

• Comparison of the efficacy of 2LHERP® versus placebo according to the duration of episodes

  6 and 12 months

• Comparison of the efficacy of 2LHERP® versus placebo according to the symptomatology during the entire relapse time

  6 and 12 months

Study Arms (2)

2LHERP® arm

EXPERIMENTAL

2LHERP® treatment (6 months of treatment)

Drug: 2LHERP®

Placebo arm

PLACEBO COMPARATOR

Placebo treatment (6 months of treatment)

Drug: Placebo

Interventions

2LHERP® 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.

Also known as: 2LHERP

2LHERP® arm

Placebo 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Labo'Life: lead

Study Sites (13)

Private practice

Lodelinsart, Charleroi, 6042, Belgium

Location

Polyclinique D'Andenne

Andenne, 5300, Belgium

Location

Dr MANOUACH Fatiha

Brussels, 1000, Belgium

Location

Dr VERHEVEN Cécile

Brussels, 1050, Belgium

Location

Private Practice

Brussels, 1180, Belgium

Location

CHU Charleroi - Hopital Marie Curie

Charleroi, 6042, Belgium

Location

Cabinet privé

Gozée, 6534, Belgium

Location

Centre Hospitalier Regional de Huy

Huy, 4500, Belgium

Location

Private Practice

Libramont, 6800, Belgium

Location

Vivalia - Centre Hospitalier de L'Ardenne - Libramont Chevigny

Libramont, 6800, Belgium

Location

Dr PETTEAU Myriam

Nivelles, 1400, Belgium

Location

Dr ROULEFF Denis

Noirefontaine, 6831, Belgium

Location

Private Practice

Oisquercq, 1480, Belgium

Location

MeSH Terms

Conditions

Herpes Genitalis

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 21, 2020
• Study Start: January 25, 2021
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (13)