CTIS2023-503814-62-00招募中1 期
Tenofovir Alafenamide Fumarate and Epstein-Barr virus activity in people with MS – The TAF-MS study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •1. Age = 18 to = 60 years, both male and female patients, 2. Diagnosis of RRMS using revised McDonald criteria of clinically definite MS.1, 3. Currently treated with natalizumab, 4. Demonstrated shedding of EBV in salvia (Shedding is defined as at least one salvia sample with >5.8 virus copies/µL cut-off)
排除标准
- •1.Known hypersensitivity or other serious adverse reaction to the active agent or other component of the study medication., 4. History of pancreatitis, 5. Prior or current disorders influencing the patient’s ability to give an informed consent or to comply with treatment and follow-up of the protocol, 6. Current users of medications that could interact with the study medication (listed in paragraph 5.6), 7. Patients who previously have been treated with hematopoietic stem cell transplantation (HSCT), 8. WBC < 1.5 x 109 /L if not caused by a reversible effect of documented ongoing medication. If WBC < 1.5 x 109 /L is caused by a reversible effect of documented ongoing medication the WBC count must be > 1,5 x 109 /L before start of study treatment., 9. Platelet (thrombocyte) count < 100 x 109 /L, Creatinin clearance < 15 ml/min, 10. ALAT more than 2 times the upper normal reference limit (ULN), 11. Serum creatinine > 200 µmol/L, 12. Serum bilirubin > 2 times the ULN, 13. Any other disease that can influence the patient safety and compliance, or the evaluation of outcome, 14. Currently enrolled in other trials of an investigational drug, or less than 30 days since ending another investigational drug., 15. Contraindications to undergo MRI such as a history of claustrophobia, inability to lie flat for approximately one hour, or metal implants (metal pins or plates, extensive non-removable dental work, cerebral aneurysm clips, pacemaker) as assessed by a standardized screening form, 2. Women who are pregnant, as verified by a serum pregnancy test at screening and during follow-up, or lactating, 3. Any ongoing infection with HIV, chronic active hepatitis, hepatitis C, or hepatitis B surface antigen positivity
研究者
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