Herpes SimplexPhase 4HEARTH-OFNCT04065971
Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.
A Phase 4 study testing 2LHERP® in people with Herpes Simplex, run by Labo'Life at 6 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Herpes Simplex
- What is being tested?
- 2LHERP®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 6 sitesBelgium
- Study dates
- 10 Mar 2020to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Charlotte BOLLE contact
6 sites in 1 country
Belgium6 sites, 6 recruiting
- Recruiting
Private Practice
Beerzel, 1650
Carola VIEHE, Dr
Carola VIEHE, Dr
- Recruiting
Cabinet privé
Beuzet, 5030
Denise Peeters, Dr
Denise Peeters, Dr
- Recruiting
Clinique Saint-Luc (Bouge)
Bouge, 5004
Audrey SCHILS, Dr
Audrey SCHILS, Dr
- Recruiting
Private Practice
Linkebeek, 1630
Isabelle JEANJOT, Dr
Isabelle JEANJOT, Dr
- Recruiting
Cabinet privé
Noirefontaine, 6831
Denis ROULEFF, Dr
Denis Rouleff, Dr
- Recruiting
Private Practice
Oisquercq, 1480
Laurence TOURNE, Dr
Laurence TOURNE, Dr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Herpes Simplex
- Being tested
- 2LHERP®, Placebo
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2LHERP®Drug
Also called 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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 2LHERP® arm | Experimental | Group N°1: 2LHERP® treatment (6 months of treatment) Receives: Drug: 2LHERP® |
| Placebo arm | Placebo comparator | Group N°1: Placebo treatment (6 months of treatment) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start10 Mar 2020
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Labo'Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065971
- Sponsor's protocol ID
- LLB-2018-01
- Acronym
- HEARTH-OF
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2019
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Orofacial Herpes Infections.
- ClinicalTrials.gov ID
- NCT04065971
- Acronym / sponsor ID
- HEARTH-OF / LLB-2018-01
- Conditions
- Herpes Simplex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Labo'LifeIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2LHERP® arm | Experimental | Drug: 2LHERP®Group N°1: 2LHERP® treatment (6 months of treatment) |
| Placebo arm | Placebo comparator | Drug: PlaceboGroup N°1: Placebo treatment (6 months of treatment) |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2LHERP®Also: 2LHERPThe 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. | Drug | 2LHERP® arm |
| PlaceboThe 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. | Drug | Placebo arm |
Primary outcome
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.
9 secondary outcomes
Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no)
Time frame: 12 months
Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no)
Time frame: 6 months
Number of episodes of herpes infection observed at 6 months
Time frame: 6 months
Time to first recurrence of herpes infection during the treatment
Time frame: 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
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
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
Quality of life evaluated via a 6-items questionnaire
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte BOLLE contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2LHERP® in people with Herpes Simplex, run by Labo'Life at 6 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura FERTE (499 71 79 64 ext. +32, laura.ferte@labolife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes episodes at 12 months. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.