Herpes Simplex, GenitalPhase 4HEARTH-GENNCT04235322
Study of 2LHERP® in Genital Herpes Infections
A Phase 4 study testing 2LHERP® in people with Herpes Simplex, Genital, run by Labo'Life at 13 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 18 to 80 years
- Conditions the study is for
- Herpes Simplex, Genital
- 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
- 6 participants
- Where
- 13 sitesBelgium
- Study dates
- 25 Jan 2021to 18 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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
13 sites in 1 country.
13 sites in 1 country
Belgium13 sites
Polyclinique D'Andenne
Andenne, 5300
Dr MANOUACH Fatiha
Brussels, 1000
Dr VERHEVEN Cécile
Brussels, 1050
Private Practice
Brussels, 1180
CHU Charleroi - Hopital Marie Curie
Charleroi, 6042
Cabinet privé
Gozée, 6534
Centre Hospitalier Regional de Huy
Huy, 4500
Private Practice
Libramont, 6800
Vivalia - Centre Hospitalier de L'Ardenne - Libramont Chevigny
Libramont, 6800
Private practice
Lodelinsart, Charleroi, 6042
Dr PETTEAU Myriam
Nivelles, 1400
Dr ROULEFF Denis
Noirefontaine, 6831
Private Practice
Oisquercq, 1480
About this study
Official title: Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Genital 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.
Read the 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.
- Conditions
- Herpes Simplex, Genital
- Being tested
- 2LHERP®, Placebo
- Medical subject headings
- Herpes Genitalis
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 | 2LHERP® treatment (6 months of treatment) Receives: Drug: 2LHERP® |
| Placebo arm | Placebo comparator | 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 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.
Measured: 12 months
Secondary outcomes (8)
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
Measured: 6 months
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
Measured: 6 and 12 months
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
Measured: 6 months
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
Measured: 6 and 12 months
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)
Measured: 6 and 12 months
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
Measured: 6 and 12 months
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
Measured: 6 and 12 months
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
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 posted21 Jan 2020
- Study start25 Jan 2021
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Why it 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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex, GenitalStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labo'Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235322
- Sponsor's protocol ID
- LLB-2019-01
- Acronym
- HEARTH-GEN
- Status last verified
- Oct 2023
- First submitted
- 16 Jan 2020
- Last updated
- 10 Oct 2023
- 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 10 Oct 2023. 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 Genital Herpes Infections
- ClinicalTrials.gov ID
- NCT04235322
- Acronym / sponsor ID
- HEARTH-GEN / LLB-2019-01
- Conditions
- Herpes Simplex, Genital
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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)
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Labo'LifeIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 21 Jan 2020 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2LHERP® arm | Experimental | Drug: 2LHERP®2LHERP® treatment (6 months of treatment) |
| Placebo arm | Placebo comparator | Drug: PlaceboPlacebo treatment (6 months of treatment) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
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 genital herpes infections at 12 months compare to placebo.
Time frame: 12 months
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.
8 secondary outcomes
Comparison of the efficacy of 2LHERP® versus placebo according to the number of episodes at 6 months.
Time frame: 6 months
Comparison of the efficacy of 2LHERP® versus placebo according to - remaining herpes infection recurrence free 6 and 12 months after the treatment initiation
Time frame: 6 and 12 months
Comparison of the efficacy of 2LHERP® versus placebo according to the time to first episode during the treatment
Time frame: 6 months
Comparison of the efficacy of 2LHERP® versus placebo according to the duration of episodes
Time frame: 6 and 12 months
Comparison of the efficacy of 2LHERP® versus placebo according to the symptomatology during the entire relapse time
Time frame: 6 and 12 months
Comparison of the efficacy of 2LHERP® versus placebo according to the use of Rescue Medication
Time frame: 6 and 12 months
Comparison of the efficacy of 2LHERP® versus placebo according to the evaluation of impact on the quality of life
Time frame: 6 and 12 months
Comparison of the efficacy of 2LHERP® versus placebo according to safety issues
Time frame: 6 months
Results and safety
The study was stopped early (reason given: 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)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 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, Genital, run by Labo'Life at 13 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: stopped early, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The study was stopped early (reason given: 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)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 genital herpes infections at 12 months compare to placebo. (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 10 Oct 2023.