Randomised study assessing efficacy and safety of telaprevir evey 8 or 12 hours with peginterferon alfa 2b and ribavirin in HCV patients

Randomised study assessing efficacy and safety of telaprevir evey 8 or 12 hours with peginterferon alfa 2b and ribavirin in HCV patients - Study of telaprevir evey 8 or 12 hours

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006758

Enrollment

Registered

2011-12-01

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 750 mg q8h plus peginterferon alfa-2b/ribavirin telaprevir 750 mg q12h plus peginterferon alfa-2b/ribavirin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Genotype 1 and high virus load IL28BSNP (rs8099917) TT or IL28BSNP (rs8099917) nonTT with transient response to prior treatment

Exclusion criteria

Exclusion criteria: 1) Patients receiving shosaiko-to 2) Autoimmune hepatitis 3) History of hypersensitivity to PEG-IFN alpha-2b and telaprevir 4) History of hypersensitivity to biological products such as vaccine 5) Decompenstated liver cirrhosis 6) HCC, malignat tumor 7) With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. 8) Pregnant or lactating women and women who may be pregnant 9) 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 weeks Safety ( moniterd clinical and laboratory evaluation) pharmacokinetics	—

Countries

Japan

Contacts

Public ContactYoshiiku Kawakami

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

082-257-5190

Outcome results

None listed

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