Effect of Telaprevir in triple therapy for chronic hepatitis C patients on Intrahepatic immunological Mechanisms

Completed

• Conditions: Hepatitis C; 10019654; 10047438

• Registration Number: NL-OMON39260
• Lead Sponsor: Stichting Maag-, Darm- en Leveronderzoek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

• Patients between 18 and 70 years of age, with a chronic hepatitis C - genotype 1 infection.
• Patients are naive, non-responders or relapsers to previous treatment with peginterferon or conventional interferon plus ribavirin combination therapy.
• High viral load (>400,000 IU/ml)
• Indication for antiviral therapy of hepatitis C according to current clinical guidelines.
• Written informed consent.

Exclusion Criteria

• Signs of progressive liver disease, beyond generally accepted criteria for HCV antiviral therapy
• History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study
• Co-infections with human immunodeficiency virus (HIV) or Hepatitis B virus (HBV).
• Presence of contra-indications for antiviral therapy with telaprevir, peginterferon or ribavirin.
• Interfering substance abuse, such as alcohol (indicator: 28 drinks/ week).
• Earlier treatment with a protease/polymerase inhibitor or treatment with peginterferon/ ribavirin within 6 months before start of therapy
•Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating and completing in the study.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in immunological parameters between patients with a high and a low<br /><br>viral load. (indirect to compare the patients who respond to the therapy and<br /><br>patients who stay infected)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>