Back to resultsStudy of 2LHERP® in Genital Herpes Infections (HEARTH-GEN)
Primary Purpose
Herpes Simplex, Genital
Status
Terminated
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
2LHERP®
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Simplex, Genital
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.
Sites / Locations
- Private practice
- Polyclinique D'Andenne
- Dr MANOUACH Fatiha
- Dr VERHEVEN Cécile
- Private Practice
- CHU Charleroi - Hopital Marie Curie
- Cabinet privé
- Centre Hospitalier Regional de Huy
- Private Practice
- Vivalia - Centre Hospitalier de L'Ardenne - Libramont Chevigny
- Dr PETTEAU Myriam
- Dr ROULEFF Denis
- Private Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
2LHERP® arm
Placebo arm
Arm Description
2LHERP® treatment (6 months of treatment)
Placebo treatment (6 months of treatment)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Comparison of the efficacy of 2LHERP® versus placebo according to the number of episodes at 6 months.
Number of episodes of herpes infections observed at month 6
Comparison of the efficacy of 2LHERP® versus placebo according to - remaining herpes infection recurrence free 6 and 12 months after the treatment initiation
Patient remaining herpes infection recurrence free 6 months and 12 months after the treatment initiation
Comparison of the efficacy of 2LHERP® versus placebo according to the time to first episode during the treatment
Time to first recurrence of herpes infection during the treatment
Comparison of the efficacy of 2LHERP® versus placebo according to the duration of episodes
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
Comparison of the efficacy of 2LHERP® versus placebo according to the symptomatology during the entire relapse time
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)
Comparison of the efficacy of 2LHERP® versus placebo according to the use of Rescue Medication
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
Comparison of the efficacy of 2LHERP® versus placebo according to the evaluation of impact on the quality of life
6-items questionnaire of quality of life
Comparison of the efficacy of 2LHERP® versus placebo according to safety issues
Adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04235322
Brief Title
Study of 2LHERP® in Genital Herpes Infections
Acronym
HEARTH-GEN
Official Title
Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Genital Herpes Infections
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Labo'life decided to end prematurely HEARTH-GEN study from April 18th 2023 due to very low recruitment rates (6/100). Labo'life decided to focus all its efforts on another study using 2LHERP® in herpes treatment, called HEARTH-OF (NCT04065971)
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
April 18, 2023 (Actual)
Study Completion Date
April 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Labo'Life
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex, Genital
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2LHERP® arm
Arm Type
Experimental
Arm Description
2LHERP® treatment (6 months of treatment)
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Placebo treatment (6 months of treatment)
Intervention Type
Drug
Intervention Name(s)
2LHERP®
Other Intervention Name(s)
2LHERP
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent genital herpes infections at 12 months compare to placebo.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Comparison of the efficacy of 2LHERP® versus placebo according to the number of episodes at 6 months.
Description
Number of episodes of herpes infections observed at month 6
Time Frame
6 months
Title
Comparison of the efficacy of 2LHERP® versus placebo according to - remaining herpes infection recurrence free 6 and 12 months after the treatment initiation
Description
Patient remaining herpes infection recurrence free 6 months and 12 months after the treatment initiation
Time Frame
6 and 12 months
Title
Comparison of the efficacy of 2LHERP® versus placebo according to the time to first episode during the treatment
Description
Time to first recurrence of herpes infection during the treatment
Time Frame
6 months
Title
Comparison of the efficacy of 2LHERP® versus placebo according to the duration of episodes
Description
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
Time Frame
6 and 12 months
Title
Comparison of the efficacy of 2LHERP® versus placebo according to the symptomatology during the entire relapse time
Description
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)
Time Frame
6 and 12 months
Title
Comparison of the efficacy of 2LHERP® versus placebo according to the use of Rescue Medication
Description
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
Time Frame
6 and 12 months
Title
Comparison of the efficacy of 2LHERP® versus placebo according to the evaluation of impact on the quality of life
Description
6-items questionnaire of quality of life
Time Frame
6 and 12 months
Title
Comparison of the efficacy of 2LHERP® versus placebo according to safety issues
Description
Adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Private practice
City
Lodelinsart
State/Province
Charleroi
ZIP/Postal Code
6042
Country
Belgium
Facility Name
Polyclinique D'Andenne
City
Andenne
ZIP/Postal Code
5300
Country
Belgium
Facility Name
Dr MANOUACH Fatiha
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Dr VERHEVEN Cécile
City
Bruxelles
ZIP/Postal Code
1050
Country
Belgium
Facility Name
Private Practice
City
Bruxelles
ZIP/Postal Code
1180
Country
Belgium
Facility Name
CHU Charleroi - Hopital Marie Curie
City
Charleroi
ZIP/Postal Code
6042
Country
Belgium
Facility Name
Cabinet privé
City
Gozée
ZIP/Postal Code
6534
Country
Belgium
Facility Name
Centre Hospitalier Regional de Huy
City
Huy
ZIP/Postal Code
4500
Country
Belgium
Facility Name
Private Practice
City
Libramont
ZIP/Postal Code
6800
Country
Belgium
Facility Name
Vivalia - Centre Hospitalier de L'Ardenne - Libramont Chevigny
City
Libramont
ZIP/Postal Code
6800
Country
Belgium
Facility Name
Dr PETTEAU Myriam
City
Nivelles
ZIP/Postal Code
1400
Country
Belgium
Facility Name
Dr ROULEFF Denis
City
Noirefontaine
ZIP/Postal Code
6831
Country
Belgium
Facility Name
Private Practice
City
Oisquercq
ZIP/Postal Code
1480
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of 2LHERP® in Genital Herpes Infections
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