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Effectiveness of PEG-IFN alfa-2b + Ribavirin combination therapy in patients with chronic hepatitis C after partial splenic embolization(PSE) or splenectomy

Effectiveness of PEG-IFN alfa-2b + Ribavirin combination therapy in patients with chronic hepatitis C after partial splenic embolization(PSE) or splenectomy - PEG-IFN alfa-2b + Ribavirin combination therapy after PSE or splenectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001735
Enrollment
20
Registered
2009-06-01
Start date
2009-03-01
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

Chronic Hepatitis C

Interventions

All patients are treated with PEG-IFN alfa-2b 1.0-1.5 microgram/kg/week + Ribavirin 400-1000/day. Treatment duration is 48-72 weeks for HCV genotype1 with high viral load and up to 24 weeks for HCV g

Sponsors

Tokushima Municipal Hospital
Lead Sponsor
Musashino Red Cross Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Platelet count <80,000/mm3 before PSE or splenectomy 2)Platelet count 80,000/mm3 or more before initiation of PEG-IFN alfa-2b + Ribavirin treatment 3)High serum HCV levels of 5 log IU/ml or more(TaqMan) or previous IFN treatment failure

Exclusion criteria

Exclusion criteria: 1)History of hypersensitivity to PEG-IFN alpha-2b or other interferons 2)History of hypersensitivity to biological products such as vaccine 3)Patients receiving shosaiko-to 4)Autoimmune hepatitis 5)Pregnant or lactating women and women who may be pregnant 6)History of hypersensitivity to ribavirin or other nucleoside analogs 7)Inadequately controlled cardiac disease 8)Hemoglobinopathy 9)Chronic renal failure or renal function disorder with creatinine clearance of 50 ml/min or less 10)With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. 11)Serious hepatic function disorder 12)Judged by investigator not to be appropriate for inclusion in this study

Design outcomes

Primary

MeasureTime frame
Sustained virological response(SVR)

Countries

Japan

Contacts

Public ContactAkemi Tsutsui

Tokushima Municipal Hospital Department of Internal Medicine

amitsu6557@yahoo.co.jp09075718249

Outcome results

None listed

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