EUCTR2011-000905-30-ES进行中(未招募)1 期
CLINICAL TRIAL WITH PROPHYLACTIC TENOFOVIR FOR HAEMATOLOGICAL CANCER PATIENTS SHOWING A HBc-Ab POSITIVE AND HBs-Ag PATTERN AND TO BE TREATED WITH RITUXIMAB (PREBLIN STUDY) - PREBLI
Rafael Esteban Mur0 个研究点目标入组 61 人开始时间: 2012年1月24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
- 61
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
- •Male and female patients over 18 years of age
- •Patients diagnosed with haematological cancer scheduled to receive treatment with rituximab alone or in combination with other chemotherapy
- •Evidence of previous exposure to HBV: HBcAb-positive patients
- •HBsAg negative patients
- •Signed Informed consent
- •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 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Intolerance to any treatment component.
- •Co-infection with HIV.
- •Presence of hepatocellular carcinoma
- •Patients with severe or moderate renal failure
- •Liver or kidney transplant or severe renal, lung or neurological diseases that under investigator criteria may interfere in the patient’s participation during the clinical trial.
- •Pregnancy or breastfeeding.
- •Treatment within the last 30 days with any experimental (non-authorised) drug.
- •Any other disease or condition that might render the patient ineligible for the trial.
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