NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Patients with following chronic hepatitis C (1)Patients with high blood HCV-RNA level (2)Patients who had no efficacy or had relapse after previous monotherapy of interferon preparation
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 Alpha (NAMALWA))|SMP-275 (Ribavirin) INN of investigational material : Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material : Injection and oral

Outcome(s)

Primary Outcome	Efficacy: The rate of undetectable HCV-RNA etc.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	<Inclusion criteria> -Patients aged 20 or older -A willingness by all patients (without distinctive of sex) to utilized adequate contraception -Patients with hepatitis C which HCV sero-group or genotype has been identified, and who are classified in following criteria by quantitative HCV-RNA analysis within 90 days prior to administration in this study. (1)Patients with high blood HCV-RNA level and its genotype 1b. (2)Patients with high blood HCV-RNA level and its genotype non-1b. Or patients who are blood HCV-RNA positive, and have no efficacy or had relapse after previous mono therapy of interferon. -Patients, who are diagnosed as chronic hepatitis based on the criteria defined by the study protocol. -Patients who are able to admit to the hospital for 2 weeks or more. etc. <Exclusion criteria> -Patients with HBs antigen positive within 180 days prior to administration in this study. -Patients with autoimmune disease or patients who are suspected of having autoimmune disease. -Patients with hepatic cirrhosis, hepatic carcinoma and hepatic failure, or patients with a history of this disease. -Patients with autoimmune hepatitis. -Patients with chronic hepatitis except C type viral hepatitis, such as alcoholic hepatitis. -Patients with serious depression or serious psychiatric disorder or patients with a history of these disorders. -Patients with desire to commit suicide and suicide attempt, or patients with a history of these disorders. -Patients with both hypertension and diabetes mellitus. etc.
Exclude criteria