EUCTR2015-000570-35-IT进行中（未招募）1 期
Prophylaxis of Hepatitis B reactivation in patients with HBV occult infection and rheumatological diseases candidates to immune suppressive treatments of finite duration. - Prophylaxis of OBI reactivation
DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UNIVERSITÀ DEGLI STUDI DI NAPOLI FEDERICO II0 个研究点目标入组 40 人开始时间: 2021年1月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age > 18 years;
- •- Patient affected by rheumatois arthrits and psoriasic arthrits, non responders to DMARDs (AR) or FANS/DMARDs (AP), candidates to immunesuppressive treatment with etanercept or adalimubab (finite therapy of 18 months)
- •- Written informed consent
- •- HBsAg negativity, anti-HBc positivity (with/without anti-HBs)
- •- HBV-DNA negativity (by Polymerase Chain Reaction)
- •- Normal liver tests (AST ed ALT <1,5 i valori max normali; PCHE, serum Albumin and Total Bilirubin levels within normal range)
- •- anti-HIV negativity
- •- anti-HCV negativity
- •- no Latent Tubercolosis infection (through IGRA test and skin test)
- •- Absence of controindications to Tenofovir
- •- Normal kidney function (ClCr > 80 ml/min, serum phospate > 2 mg/dl)
- •- No previous treatment with HBV drugs
- •- Adoption of adequate contraceptive measures in childbearing wowen
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •- Age < 18 years;
- •- Patient not affected by rheumatois arthrits and psoriasic arthrits and not candidate to immunesuppressive treatment including
- •etanercept or adalimubab (finite therapy of 18 months)
- •- No written informed consent
- •- Previous succesfull HBV vaccination
- •- HBsAg positivity
- •- Anti-HBc negativity
- •- Abnormal liver tests (AST ed ALT >1,5 max normal values; PCHE, serum Albumin and Total Bilirubin levels outside normal range)
- •- anti-HIV positivity
- •- anti-HCV positivity
- •- Latent Tubercolosis infection
- •- Controindications to Tenofovir
- •- Abnormal kidney function ( creatinine clearance < 80 ml/min, serum phosphate < 2 mg/dl)
- •- Previous treatment with HBV drugs
- •- Refusal of adoption of adequate contraceptive measures in childbearing wowen
- •- Pregnancy
- •- Breastfeeding
研究者
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