Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LEBV® and 2LXFS® on asthenia in patients with an EBV infection

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Labo'Life Belgium

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

4 Jun 2024 → ongoing

Decision date (initial)

2024-06-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Labo'Life

External identifiers

EU CT number

2024-514222-24-00

EudraCT number

2020-000085-42

ClinicalTrials.gov

NCT04308278

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Comparison of the efficacy of the treatment on fatigue severity at the end of the treatment between the 2LEBV® or the 2LXFS®/2LEBV® group versus the placebo group

Secondary objectives 6

1. Comparison of the efficacy of the treatment on other dimensions of the CIS questionnaire (other than fatigue) at the end of the treatment (V4) between the 2LEBV® or the 2LXFS®/2LEBV® group versus the placebo group
2. Comparison of the efficacy of the treatment on fatigue severity and other dimensions of the CIS questionnaire at 3 months (V3) and 12 months (V5) between the 2LEBV® or the 2LXFS®/2LEBV® group versus the placebo group
3. Comparison of the efficacy of the treatment on other symptoms related to EBV infection and their duration between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group at V3, V4 and V5. - Comparison of the evolution of the lymphocytes typing between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group at each visit until V5
4. Comparison of the evolution on IgG between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group between V0, V1 and V4
5. Safety issues
6. Comparison of the evolution of lymphocytes typing between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group at each visit until V5

Conditions and MedDRA coding

Epstein-Barr Virus infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - Patient, male or female, aged 12 years and older, - Patient with significant fatigue for 1 month or more, - Patient with at least two other symptoms among the following: Long-lasting exhaustion even after light exertion, subfebrile state, fever, loss of appetite, nausea, angina, conjunctivitis, sensitive cervical or axillary lymph nodes, erythematous and swollen tonsils, headaches, sore throat, myalgia, muscular weakness, arthralgia, splenomegaly, visual disorders, memory disorders, attention deficit disorders, sleep disorders, gastrointestinal disorders, breathing disorders, cardiovascular disorders, - Patient (and parent/legal representative if necessary) agrees to perform serology for the study, - Patient (and parent/legal representative if necessary) agrees to perform lymphocytes typing for the study, - Patient (and parent/legal representative if necessary) having the faculties to understand and respect the constraints of the study, - Signature of the Informed Consent Form by the patient (and parent/legal representative if necessary) - Patient who has a positive serology for EBV (IgG and/or IgM positive)

Exclusion criteria 1

1. - Patient who has received any treatment with the 2LEBV® or 2LXFS®, - Patient who has received any homeopathic treatment in the previous 2 months prior to the study, - Patient under immunosuppressive treatment, - Patient undergoing treatment for psychiatric disorders, - Patient having received immunotherapy or micro-immunotherapy during the last 3 months, - Patient presenting a galactose intolerance, a Lapp lactase deficiency or a glucose-galactose malabsorption syndrome (rare genetic diseases), - Pregnant or breastfeeding woman, - Patient who participated in a clinical study in the previous 2-months period, - Patient (and/or parent/legal representative if necessary) who is not sufficiently motivated to engage on the total study follow-up period, or likely to travel or move before the end of the study, - Patient with severe immunodeficiency disease requiring long term treatment (*) or patients under chemotherapy or radiotherapy, - Patient under homeopathic or phytotherapy treatment, - Patient addicted to or using recreational drugs, - Patient under guardianship and/or curatorship.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The general fatigue scale of the MFI-20 questionnaire at the end of the treatment (6-month visit - V4)

Secondary endpoints 3

1. - Physical fatigue, reduced activity, reduced motivation and mental fatigue scales on the MFI-20 questionnaire at V4, - 5 scales on the MFI-20 questionnaire at V3 and V5
2. - Other EBV infection-related symptoms: Long-lasting exhaustion even after light exertion, subfebrile state, fever, loss of appetite, nausea, angina, conjunctivitis, sensitive cervical or axillary lymph nodes, erythematous and swollen tonsil, headaches, sore throat, myalgia, muscular weakness, arthralgia, splenomegaly, visual disorders, memory disorders, attention deficit disorders, sleep disorders, gastrointestinal disorders, breathing disorders, cardiovascular disorders at V3, V4 and V5
3. - Lymphocytes typing and immune status (normo, hypo or hyperactive immune system) at V1, V3, V4 and V5, - IgG anti-EA, anti-VCA, anti-EBNA and IgM anti-VCA at V0, V1 and V4, - Safety: Occurrence of Adverse Events (AEs) and Severe Adverse Events (SAEs), considered as related or not to the study drug.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Labo'Life Belgium

Sponsor organisation

Labo'Life Belgium

Address

Avenue D'Ecolys 2 Bus 36

City

Namur

Postcode

5020

Country

Belgium

Scientific contact point

Organisation

Labo'Life Belgium

Contact name

Charlotte Bolle (Clinical Project Manager)

Public contact point

Organisation

Labo'Life Belgium

Contact name

Charlotte Bolle (Clinical Project Manager)

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications