Efficasy of combination therapy PEG-IFN-alpha-2b and Ribavirin for patients with Serogroup1 and high titer HCV.

Efficasy of combination therapy PEG-IFN-alpha-2b and Ribavirin for patients with Serogroup1 and high titer HCV. - Combination therapy of PEG-IFN-alpha-2b and Ribavirin.(Serogoup1 and high titer)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000197

Enrollment

500

Registered

2008-12-31

Start date

2004-12-01

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

Hepatitis C

Interventions

48weeks treatment with PEG-IFN-alpha-2b plus ribavirin 48 or 72weeks treatment with PEG-IFN-alpha-2b plus ribavirin 48weeks treatment with PEG-IFN-alpha-2b plus ribavirin 24weeks treatment with PEG-IF

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: CHC(Serogroup1 and high titer) Initial or retreatment with interferon

Exclusion criteria

Exclusion criteria: Pregnant or lactating women and women who may be pregnant Female patients or male patients with partners who may become pregnant who cannot practice contraception during treatment and 6 months after end of treatment Male patients with pregnant partners who cannot comply with condom use during treatment and 6 months after end of treatment History of hypersensitivity to ribavirin or other nucleoside analogs Inadequately controlled cardiac disease Hemoglobinopathy Chronic renal failure or renal function disorder with creatinine clearance of 50 ml/min or less With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. Serious hepatic function disorder Autoimmune hepatitis History of hypersensitivity to PEG-IFN alfa-2b or other interferons History of hypersensitivity to biological products such as vaccine Patients receiving shosaikoto Judged by investigator to be not appropriate for inclusion in study

Design outcomes

Primary

Measure	Time frame
Efficacy of combination therapy of PEG-IFN-alpha-2b and Ribavirin for CHC Efficacy of additional IFN therapy for intractable CHC Efficacy of combination therapy of 48 weeks PEG-IFN-alpha-2b and Ribavirin for ASC Efficacy of combination therapy of PEG-IFN-alpha-2b and Ribavirin for CHC with advanced fibrosis Efficacy of low-dose IFN therapy for intractable CHC Efficacy of ribavirin early dose down reguration for CHC Analysis of DC function and HCV specific CTL	—

Measure

Time frame

Efficacy of combination therapy of PEG-IFN-alpha-2b and Ribavirin for CHC Efficacy of additional IFN therapy for intractable CHC Efficacy of combination therapy of 48 weeks PEG-IFN-alpha-2b and Ribavirin for ASC Efficacy of combination therapy of PEG-IFN-alpha-2b and Ribavirin for CHC with advanced fibrosis Efficacy of low-dose IFN therapy for intractable CHC Efficacy of ribavirin early dose down reguration for CHC Analysis of DC function and HCV specific CTL

—

Countries

Japan

Contacts

Public ContactRyotaro Sakamori

Osaka university graduate school of medicine Gastroenterology and hepatology

sakamori@gh.med.osaka-u.ac.jp81-6-6879-3621

Outcome results

None listed

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