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.
- Conditions
- Chronic hepatitis C with compensated cirrhosis
- Registration Number
- JPRN-jRCT2080220087
- Lead Sponsor
- Dainippon Sumitomo Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
-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.
etc.
-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.
etc.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: Sustained viral response rates, defined as undetectable HCV RNA at 24 weeks after the end of treatment, etc.
- Secondary Outcome Measures
Name Time Method