ACTRN12615001167550
Completed
Phase 4
In adults with chronic hepatitis C infection, does treating the HCV infection with 12 weeks of a direct acting antiviral combination (Vikera Pak) result in an improvement of endothelial function as measured by reactive hyperaemia peripheral arterial tonometry?
ConditionsHepatitis C virus infectionEndothelial functionInfection - Other infectious diseasesCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hepatitis C virus infection
- Sponsor
- John Hunter Hospital
- Enrollment
- 16
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age \>\= 18 years
- •2\.Chronic HCV infection (HCV PCR positive for at least 6 months)
- •3\.HCV Genotype 1a or 1b
- •4\.HCV viral load at screening of \>\=10,000 IU/ml
- •5\.Absence of advanced fibrosis as defined by fibroscan within 12months prior to randomisation of \< 9\.6 kPa
- •6\.Females who are potentially fertile must agree to use 2 forms of reliable contraception
Exclusion Criteria
- •1\. Cirrhosis as defined by any one of
- •a.Fibroscan in past 12 months \>\=12kPa
- •b.Liver biopsy in past 5 years showing F4 fibrosis
- •c.Clinical or radiological evidence of portal hypertension (any of varices, splenomegaly, reversal of flow in portal vein, ascites, encephalopathy)
- •2\.Receiving prescribed medication which has a significant interaction with the AbbVie 3D\+R regimen which cannot be ceased or substituted
- •3\.Previous treatment with HCV protease\-inhibitor based therapy. (Previous treatment with interferon \+/\- ribavirin, including both relapsers and null responders is allowed).
- •4\.Screening laboratory values showing any of:
- •a.ALT or AST \> 10x ULN
- •b.eGFR \<60ml/min
- •c.Albumin \<\=30 g/dL
Outcomes
Primary Outcomes
Not specified
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