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

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ClinicalTrials.gov Identifier: NCT04235322
Recruitment Status : Recruiting
First Posted : January 21, 2020
Last Update Posted : December 23, 2022
Sponsor:
Information provided by (Responsible Party):
Labo'Life

Study Description
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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.


Condition or disease Intervention/treatment Phase
Herpes Simplex, Genital Drug: 2LHERP® Drug: Placebo Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Genital Herpes Infections
Actual Study Start Date : January 25, 2021
Estimated Primary Completion Date : October 25, 2023
Estimated Study Completion Date : October 25, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 2LHERP® arm
2LHERP® treatment (6 months of treatment)
 Drug: 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.
Other Name: 2LHERP
Placebo Comparator: Placebo arm
Placebo treatment (6 months of treatment)
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent genital herpes infections at 12 months compare to placebo. [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Comparison of the efficacy of 2LHERP® versus placebo according to the number of episodes at 6 months. [ Time Frame: 6 months ]
    Number of episodes of herpes infections observed at month 6

  2. Comparison of the efficacy of 2LHERP® versus placebo according to - remaining herpes infection recurrence free 6 and 12 months after the treatment initiation [ Time Frame: 6 and 12 months ]
    Patient remaining herpes infection recurrence free 6 months and 12 months after the treatment initiation

  3. Comparison of the efficacy of 2LHERP® versus placebo according to the time to first episode during the treatment [ Time Frame: 6 months ]
    Time to first recurrence of herpes infection during the treatment

  4. Comparison of the efficacy of 2LHERP® versus placebo according to the duration of episodes [ Time Frame: 6 and 12 months ]
    Mean duration of episodes, the duration for a given episode being defined as the number of days between the start of the episode and the last day before all symptoms recorded as 'none' for 2 consecutive days, in the patient diary

  5. Comparison of the efficacy of 2LHERP® versus placebo according to the symptomatology during the entire relapse time [ Time Frame: 6 and 12 months ]
    Level of pain recorded daily on a visual analogue scale (100mm), as well as other associated symptomatology for genital (genital lesions/craks, difficulties to urinate, genital pruritus/burn, fever, QoL), which will be consequently measured as area under the curve (AUC)

  6. Comparison of the efficacy of 2LHERP® versus placebo according to the use of Rescue Medication [ Time Frame: 6 and 12 months ]
    Use of daily rescue medicine (RM), expressed with the cumulative number of days for the treatment period, the follow-up period and the entire study period

  7. Comparison of the efficacy of 2LHERP® versus placebo according to the evaluation of impact on the quality of life [ Time Frame: 6 and 12 months ]
    6-items questionnaire of quality of life

  8. Comparison of the efficacy of 2LHERP® versus placebo according to safety issues [ Time Frame: 6 months ]
    Adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235322


Contacts
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Contact: Laura FERTE (0)499 71 79 64 ext +32 laura.ferte@labolife.com

Locations
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Belgium
Private practice Recruiting
Lodelinsart, Charleroi, Belgium, 6042
Contact: Stéphanie BLONDEL, Dr    (0)71 31 06 40 ext +32    stephanie.blondel@chu-charleroi.be   
Principal Investigator: Stéphanie BLONDEL, Dr         
CHR Mons-Hainaut Not yet recruiting
Mons, Hainaut, Belgium, 7000
Contact: Myriam PETTEAU, Dr    (0)65 88 52 12 ext +32    myriam.petteau@jolimont.be   
Principal Investigator: Myriam PETTEAU, Dr         
Polyclinique D'Andenne Recruiting
Andenne, Belgium, 5300
Contact: Emilie DE GOTTAL, Dr       emilie.degottal@gmail.com   
Principal Investigator: Emilie DE GOTTAL, Dr         
Private Practice Not yet recruiting
Brussel, Belgium, 1170
Contact: Jean-Louis DE KEYSER, Dr         
Principal Investigator: Jean-Louis DE KEYSER, Dr         
Dr MANOUACH Fatiha Recruiting
Bruxelles, Belgium, 1000
Contact: Fatiha Manouach, Dr       fatiha.manouach@yahoo.fr   
Principal Investigator: Fatiha MANOUACH, Dr         
Dr VERHEVEN Cécile Recruiting
Bruxelles, Belgium, 1050
Contact: Cécile VERHEVEN, Dr       cecile.verheven@gmail.com   
Principal Investigator: Cécile VERHEVEN, Dr         
CHU Charleroi - Hopital Marie Curie Recruiting
Charleroi, Belgium, 6042
Contact: Graziella ENA, Dr       graziella.ena@chu-charleroi.be   
Principal Investigator: Graziella ENA, Dr         
Cabinet privé Recruiting
Gozée, Belgium, 6534
Contact: Françoise WALRAVENS       francoisewalravens@yahoo.fr   
Centre Hospitalier Regional de Huy Recruiting
Huy, Belgium, 4500
Contact: Emilie DE GOTTAL, Dr       emilie.degottal@gmail.com   
Principal Investigator: Emilie DE GOTTAL, Dr         
Private Practice Recruiting
Libramont, Belgium, 6800
Contact: Pauline JANSSENS, Dr         
Principal Investigator: Pauline JANSSENS, Dr         
Vivalia - Centre Hospitalier de L'Ardenne - Libramont Chevigny Recruiting
Libramont, Belgium, 6800
Contact: Christophe SOUPART, Dr       Christophe.Soupart@vivalia.be   
Principal Investigator: Christophe SOUPART, Dr         
Private Practice Recruiting
Linkebeek, Belgium, 1630
Contact: Isabelle JEANJOT, Dr       ijeanjot@gmail.com   
Principal Investigator: Isabelle JEANJOT, Dr         
Dr PETTEAU Myriam Withdrawn
Nivelles, Belgium, 1400
Dr ROULEFF Denis Recruiting
Noirefontaine, Belgium, 6831
Contact: Denis Rouleff, Dr       drouleff@outlook.com   
Principal Investigator: Denis Rouleff, Dr         
Private Practice Recruiting
Oisquercq, Belgium, 1480
Contact: Laurence TOURNE, Dr       tourne_laurence@msn.com   
Principal Investigator: Laurence TOURNE, Dr         
Sponsors and Collaborators
Labo'Life
More Information
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Responsible Party: Labo'Life
ClinicalTrials.gov Identifier: NCT04235322    
Other Study ID Numbers: LLB-2019-01
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: December 23, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Herpes Simplex
Herpes Genitalis
Herpesviridae Infections
Infections
DNA Virus Infections
Virus Diseases
 Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases