Telaprevir therapy in Japanese patients infected with HCV

Telaprevir therapy in Japanese patients infected with HCV - Teraprevir in Japanese CH-C

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000007912

Enrollment

200

Registered

2012-05-08

Start date

2012-05-01

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 patients

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: HCV genotype 1 (subtype 1a or 1b) infected patients

Exclusion criteria

Exclusion criteria: 1) Hemoglobin <12g/dl, Neutrophil < 1500/mm3, or Platelet count <100000/mm3 2) Drug allergy to telaprevir, interferon, ribavirin or nucleoside analogues 3) Past-history of dermatological reaction of teraprevir 4) Pregnant women, etc. 5) Women cannot prevent conception. 6) Men cannot prevent conception. 7) Severe heart diseases 8) Abnormal hemoglobinemia 9) Severe renal dysfunction 10) Uncontrolable mental illness 11) Severe liver diseases 12) Uncontrolable autoimmune diseases 13) Past-history of hypersensitivity against vaccination, etc. 14) Patients take prohibited drugs, which interacts with telaprevir. 15) Doctors judged patients as inappropriate persons in this trial

Design outcomes

Primary

Measure	Time frame
Anti-viral effects against HCV	—

Secondary

Measure	Time frame
1) Association between IL28SNP and treatment response 2) Treatment response and HCV RNA dynamics 3) HCV genome and treatment response	—

Countries

Japan

Contacts

Public ContactTatsuo Kanda, M.D.

Chiba University, Graduate School of Medicine Department of Gastroenterology and Nephrology

kandat-cib@umin.ac.jp+81-43-226-2083

Outcome results