Treatment adherence in patients treated with telaprevir for a chronic hepatitis C genotype 1 infection: an observational study

Treatment adherence in patients treated with telaprevir for a chronic hepatitis C genotype 1 infection: an observational study - treatment adherence telaprevir

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39839

Enrollment

Registered

2012-11-12

Start date

2013-05-27

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatitis C

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age 18 to 70 years - BMI 18-38 kg/m2 - Treatment-naïve for HCV, virological relapse or partial virological response (> 2log10 decline at week 12) after previous treatment with peg/RBV - HCV genotype 1a or 1b - Clinical and laboratory findings consistent with a clinical diagnosis of chronic hepatitis C - Serum HCV RNA >10.000 IU/mL at baseline

Exclusion criteria

Exclusion criteria: History or symptoms of decompensated liver disease: Child-Pugh Class B or C, including ascites, hepatic encephalopathy, esophageal variceal bleeding or other signs of hepatic insufficiency or portal hypertension ;Positive results on the following screening laboratory tests: urine or serum pregnancy test (for women of childbearing potential), hepatitis B surface antigen and human immunodeficiency virus (HIV) antibody.

Design outcomes

Primary

Measure	Time frame
treatment adherence measured by MEMScaps and questionaire	—

Secondary

Measure	Time frame
virological outcome (ie RVR/SVR) plasma concentrations telaprevir/ ribavirine outcome Hospital Anxiety and Depression scale questionnaire	—

Countries

Netherlands

Outcome results