EUCTR2015-002401-10-IT进行中（未招募）1 期
Pilot multicenter open label study on treatment with Sofosbuvir/Ledipasvir FDC for patients with thalassemia major and HCV infection. - Pilot multicenter open label study on treatment with Sofosbuvir/Ledipasvir FDC for patients with tha
FONDAZIONE CASA SOLLIEVO DELLA SOFFERENZA OPERA DI SAN PIO DA PIETRELCINA OSPEDALE IRCCS0 个研究点目标入组 100 人开始时间: 2021年9月10日最近更新:
适应症
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
- 100
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
- •oPatients >18 years; HCV RNA-positive and HCV Ab positive, HBsAg negative, genotype 1 or 4 infected; Naïve or prior treatment failure.
- •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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •oHIV co-infected patients;
- •oHBsAg /HDV co-infected
- •oCreatinine clearance 50 ml/min
- •oPLT < 90.000/mm3;
- •oHCC and other neoplasia;
- •oPregnancy;
- •oBreastfeeding
- •oPatients with Child Pugh > B7;
- •oPatients with AFP levels higher than 40.
- •oChronic liver diseases other than HCV such as but not limited to: hemocromatosis, autoimmune hepatitis, metabolic liver diseases, alcoholic liver diseases, toxin exposure),
- •oPatients with severe or uncontrolled cardiac disease during the previous 24 weeks,
- •oPatients with debilitating diseases.
研究者
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