NL-OMON39260CompletedNot Applicable
Effect of Telaprevir in triple therapy for chronic hepatitis C patients on Intrahepatic immunological Mechanisms - ETIM
Stichting Maag-, Darm- en Leveronderzoek0 sites25 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
Investigators
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