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Clinical study of combination therapy of HLBI plus SMP-275 ribavirin in patients with chronic hepatitis C

Clinical study of combination therapy of HLBI plus SMP-275 ribavirin in patients with chronic hepatitis C

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220092
Enrollment
Unknown
Registered
2005-09-12
Start date
2005-09-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 Adm

Sponsors

Dainippon Sumitomo Pharma Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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. -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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Efficacy: The rate of undetectable HCV-RNA etc.—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026