A randomised comparison of safety and efficacy of triple therapy for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa 2b and ribavirin in HCV patients

A randomised comparison of safety and efficacy of triple therapy for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa 2b and ribavirin in HCV patients - Study of 12 or 36 additional weeks of peginterferon alfa 2b and ribavirin

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006952

Enrollment

230

Registered

2011-12-26

Start date

2011-12-01

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

Chronic hepatitis C

Interventions

telaprevir plus peginterferon alfa-2b/ribavirin for 12 weeks, followed by 12 additional weeks of peginterferon alfa 2b and ribavirin telaprevir plus peginterferon alfa-2b/ribavirin for 12 weeks,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Genotype 1 and high virus load(5 logIU/ml < or=) IL28BSNP (rs8099917) nonTT

Exclusion criteria

Exclusion criteria: 1) Transient response to prior treatment 2) Patients receiving shosaiko-to 3) Autoimmune hepatitis 4) History of hypersensitivity to PEG-IFN alpha-2b and telaprevir 5) History of hypersensitivity to biological products such as vaccine 6) Decompenstated liver cirrhosis 7) HCC, malignat tumor 8) With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. 9) Pregnant or lactating women and women who may be pregnant 10) Judged by investigator not to be appropriate for inclusion in this study

Design outcomes

Primary

Measure	Time frame
sustend virologic response	—

Secondary

Measure	Time frame
virologic response at4,8,12,24 ,36,48 weeks Safety ( moniterd clinical and laboratory evaluation)	—

Countries

Japan

Contacts

Public ContactYoshiiku Kawakami

graduate school of biomedical science, Hiroshima university Department and medicine and molecular science

kamy4419@hiroshima-u.ac.jp082-257-5190

Outcome results

None listed

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