TARGET-EBV in MS: Targeting Epstein Barr Virus with Tenofovir Alafenamide Fumarate in multiple sclerosis
Key facts
- Where
- Bergen, Drammen, Lørenskog, Oslo és Stavanger, NorvégiaSee the 5 sites
- Phase
- 2. fázis
Where in Norvégia
- Haukeland UniversitetssykehusBergen, NorvégiaToborzás még nem indult
- Vestre Viken HFDrammen, NorvégiaToborzás még nem indult
- Akershus University HospitalLørenskog, NorvégiaToborzás még nem indult
- Oslo University Hospital HFOslo, NorvégiaToborzás még nem indult
- Stavanger Univ. Hosp.-Rogaland Hosp.Stavanger, NorvégiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital HF
- Trial code
- EU 2025-522140-40-00
- Record updated
- 2026. október 16.
- Original description
This study will test the hypothesis that TAF is superior to placebo as add-on to anti-CD20 therapy for the treatment of neuronal damage in MS.Read full original descriptionShow less
TARGET-EBV in MS: A prospective randomized controlled parallel group phase 2b double blinded study to investigate if targeting Epstein Barr Virus with Tenofovir Alafenamide Fumarate compared to placebo as add-on treatment to anti-CD20 therapy reduces neuronal damage in multiple sclerosis
This study will test the hypothesis that TAF is superior to placebo as add-on to anti-CD20 therapy for the treatment of neuronal damage in MS.
Inclusion: Age 18 to 70 years (inclusive) at the time of signing the informed consent; Creatinine clearance > 15 ml/min; Serum bilirubin < 2 times the ULN; Negative tests for HIV, chronic active hepatitis B and hepatitis C; Treated with the anti-CD20 monoclonal antibody (CD20 mAbs) rituximab for at least 24 months prior to inclusion; Highly effective contraceptive use by women; Willingness and ability to participate in all study procedures, including lumbar puncture and air travel to Turku, Finland for MRI and PET imaging at inclusion and end of study; Diagnosis of MS (regardless of subtype) according to the revised McDonald criteria; EDSS 2-6.5 (included); A previous cerebral MRI with T2 lesion volume at least 15.00 cm3; EBV-antibodies positive in blood sample; WBC > 1.5 x 109/L; Platelet (thrombocyte) counts > 50 x 109/L; ALAT less than 2 times the upper normal reference limit (ULN); Serum creatinine < 200 µmol/L.
Exclusion: Current users of medications that could interact with the study medication or the PET tracer, for details see Section 6.9 in the protocol; Patients who previously have been treated with hematopoietic stem cell transplantation (HSCT); Currently enrolled in other trials of an investigational drug, or less than 30 days since the last treatment with another investigational drug; Exposure to more than 10 mSv doses of experimental ionizing radiation, in addition to that obtained from natural sources, in the past 12 months, equally to one CT scan during the past 12 months; History of hypersensitivity or other serious adverse reactions the study medication or the PET tracer; History of pancreatitis; Any other condition that can influence the patient’s safety and compliance, or the evaluation of outcome; Women who are pregnant, as verified by a serum pregnancy test, or lactating.