Therapeutic drug monitoring of telaprevir in chronic hepatitis C patients receiving telaprevir -based triple therapy is useful for predicting virological response.

Therapeutic drug monitoring of telaprevir in chronic hepatitis C patients receiving telaprevir -based triple therapy is useful for predicting virological response. - Plasma telaprevir concentrations in chronic hepatitis C patients receiving telaprevir -based triple therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009656

Enrollment

Registered

2012-12-28

Start date

2012-04-01

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 of genotype 1

Interventions

Patients receive 12-week triple therapy that included TVR (2250mg/day), pegylated interferon alpha-2b (PEG-IFN alpha2b) (60-150micro-g/week) and ribavirin (RBV) (600-1000mg/day) followed by a 12-week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with chronic hepatitis C patients of genotype 1

Exclusion criteria

Exclusion criteria: Exclusion criteria were: (1) positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen; (2) clinical or biochemical evidence of hepatic decompensation (ascites, bleeding varices, or encephalopathy); (3) other causes of liver disease (autoimmune hepatitis, primary biliary cirrhosis, or steatohepatitis); (4) excessive active alcohol consumption (a daily intake of more than 40 g of ethanol) or drug abuse; (5) suspected HCC at entry; or (6) treatment with antiviral or immunosuppressive agents prior to enrollment.

Design outcomes

Primary

Measure	Time frame
To investigate the impact of telaprevir (TVR) plasma trough concentrations (C-trough) on the response of TVR-based triple therapy in chronic hepatitis C patients	—

Countries

Japan

Contacts

Public ContactNorihiro Furusyo

Kyushu University Hospital Department of General Internal Medicine

092-642-5909

Outcome results

None listed

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