Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LHERP® in patients with recurrent genital herpes infections.

Phase 1

Active, not recruiting

• Conditions: Patients presenting recurrent genital herpes infections (4 or more episodes within the 12-months’ period prior to their study entry).; MedDRA version: 20.0Level: HLTClassification code 10019972Term: Herpes viral infectionsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10019948Term: Herpes simplexSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10018150Term: Genital herpesSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-001572-11-BE
• Lead Sponsor: ABO’LIFE Belgium sprl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Man or woman over 18 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent genital herpes episodes at 12 months compared to placebo.;Secondary Objective: Secondary objectives: comparison of the efficacy of 2LHERP® vs placebo, according to the following aspects: <br>- number of episodes at 6 months,<br>- remaining herpes infection recurrence free 6 and 12 months after the treatment initiation,<br>- time to first episode during the treatment,<br>- duration of episodes,<br>- symptomatology during the entire relapse time, <br>- use of Rescue Medication (RM),<br>- evaluation of impact on the quality of life,<br>- safety issues.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 12 months