EUCTR2008-007027-11-IT进行中（未招募）不适用
OTTIMIZZAZIONE DELLA PROFILASSI CON IMMUNOGLOBULINE ANTIEPATITE B (HBIG) IN PAZIENTI SOTTOPOSTI A TRAPIANTO DI FEGATO PER EPATOPATIA CORRELATA AL VIRUS DELL`EPATITE B (HBV) - ND
AZIENDA OSPEDALIERA CARDARELLI0 个研究点开始时间: 2008年12月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Pazienti sottoposti a trapianto ortotopico di fegato per malattia epatica correlata alla epatite da virus B (HBV)
- •-Adulti (eta` > 18 anni)
- •-Di entrambi i sessi
- •-Sottoposti a trapianto da almeno 12 mesi
- •-in profilassi stabile con HBIG a somministrazione endovenosa
- •-che abbiano firmato consenso informato all?arruolamento allo studio
- •-negativita` all? HBV DNA determinata con analisi genomica (PCR per HBV DNA, viremia < 102 copie/ml)
- •-con titolo anti-HBs ≥ 300 U.I./L all?arruolamento
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Recidiva di epatite da virus B
- •-Confezione con virus C (HCV) o HIV
- •-Reinfezione da virus B (HBV DNA > 102 copie/ml)
- •-Documentata incapacita` al mantenimento di un titolo anti HBs stabile in immunoprofilassi con HBIG (almeno 2 evidenze di titolo pre-somministrazione < 100 U.I./L nell?anno precedente)
- •-Ipersensibilita` o storia di manifestazioni allergiche a derivati del plasma
- •-Disturbi della coagulazione: piastrinopenia (plts< 50.000/µl), coagulopatie acquisite o congenite
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