IMProving Adherence in chronic hepatitis C patients on peg-interferon - ribavirin combination Therapy.

• Conditions: Hepatitis C; non-adherence

• Registration Number: NL-OMON28744
• Lead Sponsor: niversity Medical Center Utrecht (UMCU)

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. CHC patients eligible for antiviral treatment with PEG-interferon and ribavirin (PegIntron®/ Rebetol®);

2. 18 years of age or older;

Exclusion Criteria

Contra-indications for antiviral treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence (<80% vs. &#8805;80%), measured by pill counts.

Secondary Outcome Measures

Name	Time	Method
1. Adherence data in intervention group:<br /><br>A. No. of missed doses;<br /><br>B. No. of days without any dose;<br /><br>C. % of doses in prespecified time frame (2hrs in morning and evening).<br /><br>2. Plasma ribavirin concentrations (week 8 and 24);<br /><br>3. Virological response: RVR, EVR, week-24 response;<br /><br>4. Food composition (in subgroup of patients).