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

Phase 1

• Conditions: Patients presenting recurrent orofacial herpes infections (6 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: 20.1Level: PTClassification code 10067152Term: Oral herpesSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10019948Term: Herpes simplexSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-001085-15-BE
• Lead Sponsor: ABO’LIFE Belgium sprl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-22
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Man or woman aged 18-80 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.

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 has 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 on 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.

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 orofacial herpes infections at 12 months.;Secondary Objective: Secondary objectives: comparison of the efficacy of 2LHERP® vs placebo according to the following aspects: <br>a) number of episodes at 6 months and 12 months,<br>b) time to first episode during the treatment,<br>c) duration of episodes,<br>d) symptomatology during the entire relapse time, <br>e) use of Rescue Medication (RM),<br>f) evaluation of impact on the quality of life,<br>g) safety issues.<br><br><br>;Primary end point(s): Reduction (yes/no) in the number of recurrences of orofacial herpes infection within the 12 months following treatment initiation. ;Timepoint(s) of evaluation of this end point: 12 months