Back to resultsRandomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections. (HEARTH-OF)
Primary Purpose
Herpes Simplex
Status
Recruiting
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
Eligibility Criteria
Inclusion Criteria:
- Man or woman aged 16-80 years,
- Patient presenting 6 or more episodes of orofacial 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 PracticeRecruiting
- Cabinet privéRecruiting
- Clinique Saint-Luc (Bouge)Recruiting
- Cabinet privéRecruiting
- Private practice
- Vivalia - Centre Hospitalier de L'Ardenne - Libramont Chevigny
- Private PracticeRecruiting
- Private PracticeRecruiting
- Private practice
- Cabinet privéRecruiting
- Private PracticeRecruiting
- Private Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
2LHERP® arm
Placebo arm
Arm Description
Group N°1: 2LHERP® treatment (6 months of treatment)
Group N°1: Placebo treatment (6 months of treatment)
Outcomes
Primary Outcome Measures
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months.
The primary objective of the study will be to evaluate the change from baseline within the number of episodes of herpes infections observed for 12 months, where the baseline value is the number of episodes experienced within the 12 months preceeding study enrolment.
Secondary Outcome Measures
Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no)
The objective of this outcome will be to compare the number of patients recurrence free for 12 months between the treated and the placebo group.
Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no)
The objective of this outcome will be to compare the number of patients recurrence free for 6 months after treatment initiation between the treated and the placebo group.
Number of episodes of herpes infection observed at 6 months
The objective of this outcome will be to compare the number of herpetic episodes at 6 months and the baseline number of episodes.
Time to first recurrence of herpes infection during the treatment
The objective of this outcome will be to compare the time to first herpetic recurrence between the treated and the placebo group.
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
The objective of this outcome will be to compare the mean duration of the herpetic episodes between the treated and the placebo group.
Level of pain recorded daily on a visual analogue scale, as well as other associated symptomatology for orofacial pain, which will be consequently measured as area under the curve
The objective of this outcome will be to compare the level of pain during herpetic episodes between the treated and the placebo group.
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
The objective of this outcome will be to compare the use of rescue medication during herpetic episodes between the treated and the placebo group.
Quality of life evaluated via a 6-items questionnaire
The objective of this outcome will be to compare the quality of life between the treated and the placebo group.
Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug
The objective of this outcome is to evaluate the safety of the treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04065971
Brief Title
Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.
Acronym
HEARTH-OF
Official Title
Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Orofacial Herpes Infections.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
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 36 months with 24 months of inclusion (that may be extended if the expected number of patients is not reached after this period) and 12 months of follow-up.
Patients aged between 16 and 80 years who present recurrent orofacial herpes infections (6 or more episodes within the 12-months' period prior to their study entry).
The total number of patients to include will be 140 with 70 patients per group.
Primary objective:
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months.
Secondary objectives:
Comparison of the efficacy of 2LHERP® vs placebo according to the following aspects:
number of episodes at 6 months,
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2LHERP® arm
Arm Type
Experimental
Arm Description
Group N°1: 2LHERP® treatment (6 months of treatment)
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Group N°1: 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 orofacial herpes episodes at 12 months.
Description
The primary objective of the study will be to evaluate the change from baseline within the number of episodes of herpes infections 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
Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no)
Description
The objective of this outcome will be to compare the number of patients recurrence free for 12 months between the treated and the placebo group.
Time Frame
12 months
Title
Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no)
Description
The objective of this outcome will be to compare the number of patients recurrence free for 6 months after treatment initiation between the treated and the placebo group.
Time Frame
6 months
Title
Number of episodes of herpes infection observed at 6 months
Description
The objective of this outcome will be to compare the number of herpetic episodes at 6 months and the baseline number of episodes.
Time Frame
6 months
Title
Time to first recurrence of herpes infection during the treatment
Description
The objective of this outcome will be to compare the time to first herpetic recurrence between the treated and the placebo group.
Time Frame
6 months
Title
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
Description
The objective of this outcome will be to compare the mean duration of the herpetic episodes between the treated and the placebo group.
Time Frame
12 months
Title
Level of pain recorded daily on a visual analogue scale, as well as other associated symptomatology for orofacial pain, which will be consequently measured as area under the curve
Description
The objective of this outcome will be to compare the level of pain during herpetic episodes between the treated and the placebo group.
Time Frame
12 months
Title
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
Description
The objective of this outcome will be to compare the use of rescue medication during herpetic episodes between the treated and the placebo group.
Time Frame
12 months
Title
Quality of life evaluated via a 6-items questionnaire
Description
The objective of this outcome will be to compare the quality of life between the treated and the placebo group.
Time Frame
6 and 12 months
Title
Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug
Description
The objective of this outcome is to evaluate the safety of the treatment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Man or woman aged 16-80 years,
Patient presenting 6 or more episodes of orofacial 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura FERTE
Phone
499 71 79 64
Ext
+32
Email
laura.ferte@labolife.com
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte BOLLE
Email
charlotte.bolle@labolife.com
Facility Information:
Facility Name
Private Practice
City
Beerzel
ZIP/Postal Code
1650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carola VIEHE, Dr
First Name & Middle Initial & Last Name & Degree
Carola VIEHE, Dr
Facility Name
Cabinet privé
City
Beuzet
ZIP/Postal Code
5030
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Peeters, Dr
First Name & Middle Initial & Last Name & Degree
Denise Peeters, Dr
Facility Name
Clinique Saint-Luc (Bouge)
City
Bouge
ZIP/Postal Code
5004
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey SCHILS, Dr
First Name & Middle Initial & Last Name & Degree
Audrey SCHILS, Dr
Facility Name
Cabinet privé
City
Hamme-Mille
ZIP/Postal Code
1320
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Hausdorfer, Dr
First Name & Middle Initial & Last Name & Degree
Susanne Hausdorfer, Dr
Facility Name
Private practice
City
Libramont
ZIP/Postal Code
6800
Country
Belgium
Individual Site Status
Terminated
Facility Name
Vivalia - Centre Hospitalier de L'Ardenne - Libramont Chevigny
City
Libramont
ZIP/Postal Code
6800
Country
Belgium
Individual Site Status
Terminated
Facility Name
Private Practice
City
Linkebeek
ZIP/Postal Code
1630
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle JEANJOT, Dr
First Name & Middle Initial & Last Name & Degree
Isabelle JEANJOT, Dr
Facility Name
Private Practice
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernadette BLOUARD, Dr
First Name & Middle Initial & Last Name & Degree
Bernadette BLOUARD, Dr
Facility Name
Private practice
City
Nivelles
ZIP/Postal Code
1400
Country
Belgium
Individual Site Status
Terminated
Facility Name
Cabinet privé
City
Noirefontaine
ZIP/Postal Code
6831
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis ROULEFF, Dr
First Name & Middle Initial & Last Name & Degree
Denis Rouleff, Dr
Facility Name
Private Practice
City
Oisquercq
ZIP/Postal Code
1480
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence TOURNE, Dr
First Name & Middle Initial & Last Name & Degree
Laurence TOURNE, Dr
Facility Name
Private Practice
City
Wavre
ZIP/Postal Code
1300
Country
Belgium
Individual Site Status
Terminated
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.
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