Study of 2LHERP in Genital Herpes Infections

  • STATUS
    Recruiting
  • End date
    Jan 25, 2023
  • participants needed
    100
  • sponsor
    Labo'Life
Updated on 8 September 2021
antiviral
antiviral therapy
herpes simplex

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.

Description

The study duration will be maximum 24 months with 12 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 n1 = 2LHERP (6 months of treatment) Group n2 = 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.

Details
Condition Genital Herpes
Treatment Placebo, 2LHERP®
Clinical Study IdentifierNCT04235322
SponsorLabo'Life
Last Modified on8 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note