Recruiting PHASE4 EBV Infection

Tests treatment safety and results for EBV Infection

Official title Study to Evaluate the Efficacy of 2LEBV® and 2LXFS® on Asthenia in Patients With an Epstein-Barr Virus Infection

ClinicalTrials.gov ID: NCT04308278

What this study is testing

What is 2LEBV® / 2LXFS®?

2LEBV® / 2LXFS® is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ebv infection.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Worldwide, 95% of adults are infected with Epstein-Barr Virus (EBV). These infections may cause different diseases.
  • Phase 4: studies an already-approved treatment
  • You might receive a placebo (an inactive treatment) instead of the study drug.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 12 and older

You may be able to join if

  • Pré-
  • Patients, male or female, aged 12 years and older,
  • Patient with 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...
  • Patient (and/or parents if necessary) agrees to perform serology for the study,

You likely can't join if

  • 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,
See the full eligibility criteria
Who can join
  • Pré-
  • Patients, male or female, aged 12 years and older,
  • Patient with 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...
  • Patient (and/or parents if necessary) agrees to perform serology for the study,
  • Patient (and/or parents if necessary) agrees to perform lymphocyte typing for the study during the pre-inclusion visit,
  • Patients (and/or 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/or parents if necessary). \- Patient who have a positive serology for EBV (IgG and/or IgM positive).
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Aartselaar, Belgium
  • Boortmeerbeek, Belgium
  • Brussels, Belgium
  • Ghent, Belgium
  • Jette, Belgium
  • Limal, Belgium
  • Marche-en-Famenne, Belgium
  • Schoten, Belgium
  • Stavelot, Belgium
  • Waregem, Belgium

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Aartselaar, Belgium; Boortmeerbeek, Belgium; Brussels, Belgium; Ghent, Belgium; Jette, Belgium; Limal, Belgium and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.