Efficacy of switching therapy to interferon beta plus ribavirin combination therapy for patients with chronic hepatitis C who discontinues triple therapy with protease inhibitor or dual therapy with Peg-IFN plus RBV combination therapy

Efficacy of switching therapy to interferon beta plus ribavirin combination therapy for patients with chronic hepatitis C who discontinues triple therapy with protease inhibitor or dual therapy with Peg-IFN plus RBV combination therapy - Efficacy of switching therapy to interferon beta plus ribavirin combination therapy for patients with chronic hepatitis C who discontinues dual therapy with Peg-IFN plus RBV combination therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011246

Enrollment

Registered

2013-08-01

Start date

2013-06-13

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

&lt

Regimen for patients who discontinued triple therapy with protease inhibiter, Peg-IFN plus RBV &gt

- HCV-RNA disappeared within 12 treatment weeks Interferon beta: 6M IU thrice a week, total of 24weeks Ribavirin: Body weight

less than 60kg, 600mg/day p.o., total of 24weeks, 60kg - 80kg, 800mg/day p.o., total of 24 weeks, more than 80kg, 1000mg/day p.o., total of 24weeks - HCV-RNA did not disappear at the point of disco

less than 60kg, 600mg/day p.o., total of 24weeks, 60kg - 80kg, 800mg/day p.o., total of 24 weeks, more than 80kg, 1000mg/day p.o., total of 24weeks &lt

Regimen for patients who discontinued dual therapy with Peg-IFN plus RBV &gt

- HCV-RNA disappeared within 12 treatment weeks Interferon beta: 6M IU thrice a week, total of 48weeks Ribavirin: Body weight

less than 60kg, 600mg/day p.o., total of48weeks, 60kg - 80kg, 800mg/day p.o., total of 48weeks, more than 80kg, 1000mg/day p.o., total of 48weeks - HCV-RNA disappeared during 12 - 36 treatment week

less than 60kg, 600mg/day p.o., total of 72weeks, 60kg - 80kg, 800mg/day p.o., total of 72 weeks, more than 80kg, 1000mg/day p.o., total of 72weeks Patients without switching therapy to interferon bet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients over 20 years old 2) Patients with chronic hepatitis C who discontinues triple therapy with protease inhibitor, Peg-IFN plus RBV or dual therapy with i Peg-IFN plus RBV 3) - Patients who discontinued triple therapy within 12 treatment weeks - Patients who discontinued triple therapy with disappearance of HCV-RNA after 12 treatment weeks 4) - Patients who discontinued dual therapy within 36 treatment weeks regardless of disappearance of HCV-RNA - Patients who discontinued dual therapy with disappearance of HCV-RNA after 36 treatment weeks 5) Reasons for discontinuing case is as below 1. depression 2. insomnia 3. severe fatigue 4. rash caused by pegylated interferon 5. platelet counts are less than 50,000/microL

Exclusion criteria

Exclusion criteria: 1) Patients with co-infection with hepatitis B virus 2) Patients with co-infection with human immunodeficiency virus 3) Patients with alcoholic liver disorder or autoimmune hepatitis 4) Patients with uncompensated cirrhosis or hepatic failure 5) Patients with multiple organ failure or immunological deficiency 6) Patients with severe depression or past history of psychiatric disorder 7) Patients with chronic renal failure 8) Patients in pregnancy or lactating or patients who expect to become pregnant 9) Patients whose hemoglobin levels are less than 8.5g/dL 10) Patients whose platelet counts are less than 25,000/microL 11) Patients whose neutrophil counts are less than 500 /microL 12) Patients whom investigator disqualified

Design outcomes

Primary

Measure	Time frame
- The rate of patients completing treatment -Sustained virological response rate; the rate of undetectable HCV RNA at end of treatment and at 24 weeks after completion of treatment	—

Countries

Japan

Contacts

Public ContactNaoki Hiramatsu

Osaka University Graduate School of Medicine The department of Gastroenterology and Hepatology

hiramatsu@gh.med.osaka-u.ac.jp06-6879-3621

Outcome results

None listed

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