Clinical Trials Register

Summary
EudraCT Number:	2020-000085-42
Sponsor's Protocol Code Number:	LLB-2019-03
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:	2020-08-29
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2020-000085-42

A.3

Full title of the trial

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

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Étude randomisée, versus placebo en double aveugle visant à évaluer l’efficacité du 2LEBV® et du 2LXFS® sur la fatigue des patients atteints d’une infection à l’EBV.

A.3.2

Name or abbreviated title of the trial where available

EBVAST

A.4.1

Sponsor's protocol code number

LLB-2019-03

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	LABO'LIFE Belgium sprl
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	LABO'LIFE Belgium
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	LABO'LIFE France
B.5.2	Functional name of contact point	Clin research Coord, Léa FERRAND
B.5.3	Address:
B.5.3.1	Street Address	1, Rue François Bruneau
B.5.3.2	Town/ city	Nantes
B.5.3.3	Post code	44000
B.5.3.4	Country	France
B.5.4	Telephone number	+33642624372
B.5.5	Fax number	+33549721120
B.5.6	E-mail	lea.ferrand@labolife.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	2LEBV®
D.2.1.1.2	Name of the Marketing Authorisation holder	LABO'LIFE Belgium Holder
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	2LEBV®
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Pillules
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oromucosal use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	Yes
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.1.1.1	Trade name	2LXFS®
D.2.1.1.2	Name of the Marketing Authorisation holder	Labo'Life Belgium sprl
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	2LXFS®
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Pillules
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oromucosal use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	Yes
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Pillules
D.8.4	Route of administration of the placebo	Oromucosal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Epstein-Barr Virus infection

E.1.1.1

Medical condition in easily understood language

Epstein-Barr Virus infection

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10014077
E.1.2	Term	EBV infection
E.1.2	System Organ Class	100000004862

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10014078
E.1.2	Term	EBV infection reactivation
E.1.2	System Organ Class	100000004862

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10056906
E.1.2	Term	EBV antibody positive
E.1.2	System Organ Class	100000004848

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10056907
E.1.2	Term	EBV antigen positive
E.1.2	System Organ Class	100000004848

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

E.2.2

Secondary objectives of the trial

- 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
- 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.
- 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.
- Comparison of the evolution on IgG between the 2LEBV® and 2LXFS®/2LEBV® group versus the placebo group between V0, V1 and V4
- Safety issues.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients, 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, conjunctivis, 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/or parents if necessary) agrees to perform serology for the study,
- Patient (and parents if necessary) agrees to perform lymphocyte typing for the study,
- Patients (and parents if necessary) having the faculties to understand and respect the constraints of the study,
- Signature of the Informed Consent Form by the patient (and parents if necessary).
- Patient who have a positive serology for EBV (IgG and/or IgM positive).

E.4

Principal exclusion criteria

- Patient who have received any treatment with the 2LEBV® or 2LXFS®,
- Patients who have received any homeopathic treatment in the previous 2 months prior to the study,
- Patients under immunosuppressive treatment,
- Patient undergoing treatment for psychiatric disorders,
- Patients having received immunotherapy or micro-immunotherapy during the last 3 months,
- Patients with known lactose intolerance,
- Pregnant or breastfeeding women,
- Patients who participated in a clinical study in the previous 2-months period,
- Patients (and/or parents of patients if necessary) who are not sufficiently motivated to engage on the total study follow-up period, or likely to travel or to move before the end of the study,
- Patients with severe immunodeficiency disease requiring long term treatment (*) or patients under chemotherapy or radiotherapy,
- Patients under homeopathic or phytotherapy treatment,
- Patients addicted to or using recreational drugs,
- Patient under guardianship and/or curatorship,
(*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.

E.5 End points

E.5.1

Primary end point(s)

The general fatigue scale of the MFI-20 questionnaire at the end of the treatment.

E.5.1.1

Timepoint(s) of evaluation of this end point

6-month visit - V4.

E.5.2

Secondary end point(s)

- 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,
- Other EBV related infection symptoms: Long-lasting exhaustion even after light exertion, subfebrile state, fever, loss of appetite, nausea, angina, conjunctivis, 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 and duration of these symptoms (only for symptom that can be assesses by patients)
- Lymphocytes typing and immune status (normo, hypo or hyperactive immune system) at V1, V3, V4 and V5,
- IgG anti-EA, anti-VCA and anti-EBNA 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.

E.5.2.1

Timepoint(s) of evaluation of this end point

- 6 months - V4,
- 3 months - V3 and 12 months - V5,
- 3 months - V3, 6 months - V4 and 12 months - V5
- Inclusion visit - V1, 3 months - V3, 6 months - V4 and 12 months -V5,
- pre-inclusion visit - V0, Inclusion visit - V1 and 6 months - V4
- Until 6 months

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Information not present in EudraCT

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Minor people

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

There is no plan for treatment of the subject after the subject has ended participation of the trial. Each investigator will discuss of another treatment with the subject in case of unsuccessful trial treatment.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-08-11

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status

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Orphan Designation Number:
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