Chronic hepatitis C with compensated cirrhosis
Conditions
Interventions
investigational material(s)
Generic name etc : HLBI (Interferon Alfa (NAMALWA))
INN of investigational material :
Therapeutic category code : 639 Other biological preparations
Dosage and Administrati
Sponsors
Dainippon Sumitomo Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Sustained viral response rates, defined as undetectable HCV RNA at 24 weeks after the end of treatment, etc. | — |
Outcome results
None listed