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Prevention study for Epstein-Barr Virus Infections
Official title Evaluation of the Efficacy of a Treatment by One Single Dose of Rituximab (375mg/m2 ) in the Prevention of the Epstein Barr Virus (EBV) Primary Infection and Post-transplant Lymphoproliferative Disorder in Adult EBV Seronegative Patients Who Received an EBV Seropositive Kidney Allograft
ClinicalTrials.gov ID: NCT04989491
What this study is testing
What is Rituximab?
Rituximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for epstein-barr virus infections.
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
- Epstein Barr virus infects over 90% of human population and persists during lifetime. After infecting B lymphocytes, EBV remains latent in memory B cells.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (age ≥18 years at transplantation)
- Kidney and kidney pancreas simultaneous transplantation
- EBV seronegative patients (IgG anti EBNA, IgG anti VCA and IgM anti VCA negative) (from 6 months before transplantation to the day of...
- Patient who have given written informed consent
- Negative pregnancy test and use of contraception during all the study
You likely can't join if
- Patient with known HBV active infection
- Allergy to Rituximab
- Severe Immune deficiency
- Severe cardiac insufficiency
- Pregnant or lactating women
- Women of child bearing potential unless they are using a birth control method
See the full eligibility criteria
- Adult patients (age ≥18 years at transplantation)
- Kidney and kidney pancreas simultaneous transplantation
- EBV seronegative patients (IgG anti EBNA, IgG anti VCA and IgM anti VCA negative) (from 6 months before transplantation to the day of transplantation, included)
- Patient who have given written informed consent
- Negative pregnancy test and use of contraception during all the study
- EBV positive donor
- Patient affiliated to a social security scheme
- Patient with known HBV active infection
- Allergy to Rituximab
- Severe Immune deficiency
- Severe cardiac insufficiency
- Pregnant or lactating women
- Women of child bearing potential unless they are using a birth control method
- Patient under judicial protection or under guardianship
- Patient currently participating in another clinical trial investigating drugs. Observational studies are not considered as an exclusion criterion
- Any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, is incompatible with the participation in the study
- Unlikely to comply with the visits scheduled in the protocol. Exclusion Criteria: \-
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France. 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.