Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections. (HEARTH-OF)

October 29, 2024 updated by: Labo'Life

Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Orofacial Herpes Infections.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. number of episodes at 6 months,
  2. time to first episode during the treatment,
  3. duration of episodes,
  4. symptomatology during the entire relapse time,
  5. use of Rescue Medication (RM),
  6. evaluation of impact on the quality of life,
  7. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Beerzel, Belgium, 1650
        • Recruiting
        • Private Practice
        • Contact:
          • Carola VIEHE, Dr
        • Principal Investigator:
          • Carola VIEHE, Dr
      • Beuzet, Belgium, 5030
        • Recruiting
        • Cabinet privé
        • Contact:
          • Denise Peeters, Dr
        • Principal Investigator:
          • Denise Peeters, Dr
      • Bouge, Belgium, 5004
        • Recruiting
        • Clinique Saint-Luc (Bouge)
        • Contact:
          • Audrey SCHILS, Dr
        • Principal Investigator:
          • Audrey SCHILS, Dr
      • Linkebeek, Belgium, 1630
        • Recruiting
        • Private Practice
        • Contact:
          • Isabelle JEANJOT, Dr
        • Principal Investigator:
          • Isabelle JEANJOT, Dr
      • Noirefontaine, Belgium, 6831
        • Recruiting
        • Cabinet privé
        • Principal Investigator:
          • Denis Rouleff, Dr
        • Contact:
          • Denis ROULEFF, Dr
      • Oisquercq, Belgium, 1480
        • Recruiting
        • Private Practice
        • Contact:
          • Laurence TOURNE, Dr
        • Principal Investigator:
          • Laurence TOURNE, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 2LHERP® arm
Group N°1: 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 Names:
  • 2LHERP
Placebo Comparator: Placebo arm
Group N°1: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months.
Time Frame: 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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no)
Time Frame: 12 months
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.
12 months
Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no)
Time Frame: 6 months
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.
6 months
Number of episodes of herpes infection observed at 6 months
Time Frame: 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.
6 months
Time to first recurrence of herpes infection during the treatment
Time Frame: 6 months
The objective of this outcome will be to compare the time to first herpetic recurrence between the treated and the placebo group.
6 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
Time Frame: 12 months
The objective of this outcome will be to compare the mean duration of the herpetic episodes between the treated and the placebo group.
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
Time Frame: 12 months
The objective of this outcome will be to compare the use of rescue medication during herpetic episodes between the treated and the placebo group.
12 months
Quality of life evaluated via a 6-items questionnaire
Time Frame: 6 and 12 months
The objective of this outcome will be to compare the quality of life between the treated and the placebo group.
6 and 12 months
Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug
Time Frame: 6 months
The objective of this outcome is to evaluate the safety of the treatment
6 months
Level of pain recorded daily as well as other associated symptomatology for orofacial pain, which will be consequently measured as area under the curve
Time Frame: 12 months
The objective of this outcome will be to compare the level of pain during herpetic episodes between the treated and the placebo group.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Labo'Life

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LLB-2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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