NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Chronic hepatitis C with compensated cirrhosis
Date of first enrollment	12/09/2005
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : HLBI (Interferon Alfa (NAMALWA)) INN of investigational material : Therapeutic category code : 639 Other biological preparations Dosage and Administration for Investigational material : Injection

Outcome(s)

Primary Outcome	Efficacy: Sustained viral response rates, defined as undetectable HCV RNA at 24 weeks after the end of treatment, etc.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 69age old
Gender	Both
Include 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. <Exclusion criteria> -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.
Exclude criteria