NCT01987791Unknown不适用
Comparison of Prednisone and Cyclosporine in the Treatment of Thrombocytopenia in Patients With Cirrhosis Associated With Hepatitis B in China: a Collaborative, Open-label, Real World Observational Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 主要终点
- treatment failure
研究概览
简要总结
To compare the safety and efficacy of 12 months of low dose prednisone with low dose cyclosporine combined with entecavir in patients with thrombocytopenia associated with HBV-related cirrhosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed HBV-associated cirrhosis
- •had an serum HBV DNA level of more than 500 IU per milliliter
- •have compensated liver cirrhosis
- •thrombocytopenia (defined as a platelet count of <30,000 per cubic millimeter)
- •accompanied with bleed tendency (including petechial, episxias, ecchymosis, hemoptysis, hematemesis and hematochezia)
- •have a liver-biopsy specimen indicative of cirrhosis, ultrasonography and/or computed tomographic imaging evidence of cirrhosis, or endoscopic evidence of portal hypertension(splenomegaly, ascites, and esophageal varicose)
排除标准
- •hepatocellular carcinoma
- •decompensated cirrhosis
- •coagulation function abnormal
- •had a history of other disease (e.g. aplastic anemia, autoimmune disease, idiopathic thrombocytopenia et al) that could induced thrombocytopenia
- •co-infected with the human immunodeficiency virus
- •co-infected with hepatitis C virus
- •co-infected with hepatitis D virus
- •had a coexisting serious medical or psychiatric illness
- •serum creatinine level was more than 1.5 times the upper limit of the normal range
结局指标
主要结局
treatment failure
时间窗: 12 months
The primary efficacy outcome was treatment failure, defined as the composite of (1) any platelet count below 50×109/L after four weeks treatment; (2) significant bleeding, defined as grade 2 severity from any anatomical site as per the ITP bleeding scale that defines bleed grades (0, none; 1, mild; or 2, marked) by objective criteria of 9, based on events that occurred since the last study visit; or (3) rescue treatment administered because of severe thrombocytopenia, bleeding, or a planned invasive procedure.
次要结局
- proportion of patients with a complete platelet count response(at 4 weeks, at 6 months , and at 12 months)
- proportion of patients with an overall platelet count response(at 4 weeks, at 6 months , and at 12 months)
研究者
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