2025-522781-77-01招募中2 期
Dosing EvaLuation of Tenofovir Alafenamide on Epstein-Barr Virus (The DELTA-EBV study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Number of participants experiencing treatment-emergent adverse events (AEs).
研究概览
简要总结
The main objective of the study is to determine the safety and tolerability of a sequential dose escalation regimen of TAF (25mg, 50mg, and 100mg) in healthy individuals
研究设计
- 分配方式
- Na
- 主要目的
- Delta-ebv
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 to ≤ 65 years, both male and female participants.
- •Positive serological testing for EBNA1 or VCA IgG.
- •Creatinine clearance (CrCL) >= 80 mL/min.
- •EBV-positive otherwise healthy individuals
- •Women of childbearing potential (WOCBP) able and willing to use highly effective methods of birth control3 that result in a low failure rate of less than 1% per year when used consistently for the duration of the study + 7 days after last dose to comply with CTCG Contraception guidance Version 1.2 (CTCG 07.03.2024).
- •Able and willing to perform all study procedures, including at-home saliva collection, for the duration of the study
- •Negative hepatitis B serology defined as hepatitis B surface antigen (HBsAg) negative and Hepatitis B core antibody (anti-HBc) negative.
排除标准
- •Known hypersensitivity or severe adverse reactions to the study medication’s active agent or other component.
- •Platelet (thrombocyte) count < 100 x 10^9/L.
- •ALAT over the upper normal reference limit.
- •Serum creatinine over the upper normal reference limit.
- •Serum bilirubin over the upper normal reference limit.
- •Any other disease that can influence participant safety and compliance or the evaluation of the outcome.
- •Currently enrolled in another investigational drug trial, or within 30 days of completing one. Participants are excluded until systemic exposure has cleared, defined as 5.5 half-lives or 30 days, whichever is longer
- •Women who are pregnant, as verified by a serum pregnancy test at screening and during follow-up, or lactating.
- •Any known ongoing infection with HIV, chronic active hepatitis, hepatitis C, or hepatitis B surface antigen positivity.
- •Participants with any evidence of current or prior hepatitis B infection (including anti-HBc positivity) will be excluded to eliminate the risk of viral reactivation or flare following discontinuation of study treatment
- •History of pancreatitis.
- •Prior or current disorders influence the participant’s ability to give 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).
- •Participants previously treated with hematopoietic stem cell transplantation (HSCT).
- •Participants who previously have been treated with any chemotherapeutic medication.
- •WBC < 1.5 x 10^9/L if not caused by a reversible effect of documented ongoing medication. If WBC < 1.5 x 10^9/L is caused by a reversible effect of documented ongoing medication the WBC count must be > 1.5 x 10^9/L before start of study treatment.
- •History of liver disease
- •History of kidney disease
研究组 & 干预措施
Vemlidy 25 mg film-coated tablets
Test
干预措施: Vemlidy 25 mg film-coated tablets (Drug)
结局指标
主要结局
Number of participants experiencing treatment-emergent adverse events (AEs).
Number of participants experiencing treatment-emergent adverse events (AEs).
次要结局
- Within-participants changes in EBV shedding frequency in saliva, defined as number of samples with detectable levels of EBV during sequential dose escalation.
- Within-participant changes in EBV viral load in saliva during sequential dose escalation.
- Within-participant changes in EBV specific CD4 T cells by ELISPOT assay during sequential dose escalation.
- Within-participant changes in IgG antibodies to EBNA1 and VCA during sequential dose escalation.
- Secondary safety endpoints related to the IMP
研究者
Andrea Kyvik Habbestad
Scientific
Helse Bergen HF
研究点 (2)
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