2023-503814-62-00招募中2 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
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Total number of SAEs from baseline to 24 weeks after start of study treatment
研究概览
简要总结
The objective of the study is to determine the safety of TAF as an add-on therapy to natalizumab.
研究设计
- 分配方式
- Randomized
- 主要目的
- 6 Month Treatment Phase
- 盲法
- Double (Carer, Analyst, Investigator, Subject, Monitor)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 to ≤ 70 years, both male and female patients
- •Diagnosis of RRMS using revised McDonald criteria of clinically definite MS.1
- •Currently treated with natalizumab
- •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
- •Known hypersensitivity or other serious adverse reaction to the active agent or other component of the study medication.
- •History of pancreatitis
- •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
- •Current users of medications that could interact with the study medication (listed in paragraph 5.6)
- •Patients who previously have been treated with hematopoietic stem cell transplantation (HSCT)
- •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.
- •Platelet (thrombocyte) count < 100 x 109 /L
- •Creatinin clearance < 15 ml/min
- •ALAT more than 2 times the upper normal reference limit (ULN)
- •Serum creatinine > 200 µmol/L
- •Serum bilirubin > 2 times the ULN
- •Any other disease that can influence the patient safety and compliance, or the evaluation of outcome
- •Currently enrolled in other trials of an investigational drug, or less than 30 days since ending another investigational drug.
- •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
- •Women who are pregnant, as verified by a serum pregnancy test at screening and during follow-up, or lactating
- •Any ongoing infection with HIV, chronic active hepatitis, hepatitis C, or hepatitis B surface antigen positivity
结局指标
主要结局
Total number of SAEs from baseline to 24 weeks after start of study treatment
Total number of SAEs from baseline to 24 weeks after start of study treatment
次要结局
- Change in IgG antibodies to EBNA1 and other EBV antigens from baseline to 2, 8 and 24 weeks after start of study treatment.
- Change in EBV viral load in saliva from baseline to 2, 8 and 24 weeks after start of study treatment.
- Key secondary endpoints Change in EBV shedding in saliva
研究者
Øivind Torkildsen
Scientific
Helse Bergen HF
研究点 (7)
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