CHESS - Curing Hepatitis C: Effect on the Endothelium and cardiovaScular riSk - a pilot single arm trial, assessing the effect of hepatitis C virus (HCV) treatment with 12 weeks of paritaprevir/ritonavir/ombitasvir, dasabuvir +/- ribavirin on endothelial function.

Phase 4

Completed

• Conditions: Hepatitis C virus infection; Endothelial function; Infection - Other infectious diseases; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12615001167550
• Lead Sponsor: John Hunter Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

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
d.INR >1.3
e.Haemaglobin <110 g/dL
f.Platelet count<140 cells/mm3
g.Total serum bilirubin >2 x ULN
5.Known latex allergy
6.Receiving nitrates that cannot be ceased (isosorbide mononitrate, GTN patch)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in RH-PAT index over 12 weeks of HCV treatment compared with a 4 week baseline period [3 baseline time points (Week 0, 2 and 4), 4 time points whilst receiving HCV treatment (study weeks 5, 6, 8, 16, which is treatment weeks 1,2,4 and 12)]