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

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: Recruiting
• Conditions: Herpes Simplex
• Intervention / Treatment: Drug: 2LHERP®; Drug: Placebo

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: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Laura FERTE; Phone Number: +32 499 71 79 64; Email: laura.ferte@labolife.com
• Study Contact Backup: Name: Charlotte BOLLE; Email: charlotte.bolle@labolife.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	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

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	6 months
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.	6 months
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.	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	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	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	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	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	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

• Sponsor: Labo'Life

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Virus Diseases; DNA Virus Infections; Skin Diseases; Skin Diseases, Infectious; Skin Diseases, Viral; Herpes Simplex; Herpesviridae Infections
• Other Study ID 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