JPRN-jRCT2080220087未知3 期
A phase 3, open-label, parallel-group study to evaluate the dosing regimens of human lymphoblastoid interferon (HLBI) in hepatitis C patients with compensated cirrhosis.
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研究概览
简要总结
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研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 69age old（—）
- 性别
- All
入选标准
- •-Patients aged 20 to less than 70.
- •-Documented cirrhosis, defined by either i) or ii):
- •i) Liver biopsy or laparoscopy within 3 years prior to enrollment.
- •ii) Formula for prediction of cirrhosis using latest laboratory data obtained on the same day within 90 days prior to enrollment.
- •-Compensated patients without either jaundice, ascites, edema, hepatic encephalopathy or gastrointestinal hemorrhage.
- •-Patients with HCV serogroup 1 or patients with serogroup other than 1 whose serum HCV RNA level is less than 4 Meq/mL or 500 KIU/mL.
- •-Patients who are able to admit to the hospital for 2 weeks or more.
- •-Patients with autoimmune hepatitis.
- •-Patients with chronic liver diseases except chronic hepatitis C with compensated cirrhosis, such as alcoholic hepatitis.
- •-Patients with a history of decompensated cirrhosis or hepatic carcinoma.
- •-Patients with central nervous system or psychiatric disorder or patients with a history of these disorders.
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- 未提供
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