Study of Hepatic Responses in Patients Receiving Direct-acting Anti-HCV Drugs

Completed

Conditions studied: Hepatitis C

In brief

This study is designed to obtain and store samples of serum and liver tissue in HCV (HepC Virus)-infected patients being treated with direct-acting antiviral (DAA) therapy, and to determine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood. The introduction of new DAAs regimens that do not include IFN provides unique and novel opportunities to examine whether successful treatment-induced eradication of viral antigen results in reconstitution of T cell immunity. serum and liver tissue samples will be collected and stored in hopes of improving treatment and outcomes for future patients.

Key facts

Study ID

NCT02532907

Run by

University of Colorado, Denver

People needed

5

Starts

2015-08-01

Expected to finish

2018-07-10

Last updated by the study team

2018-09-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• Ages 18-70
• HCV-infected patients being treated with direct-acting antiviral (DAA) therapy.

You may not qualify if…

• Pregnant women or females of childbearing potential that are not on contraception
• Institutionalized or mentally disabled persons
• Prisoners
• Unwilling or unable to provide informed consent
• Subjects who are HIV positive
• Anticipated inability to follow up
• Chronic anemia
• Platelet count < 100 for liver biopsy patients who have documented fatty liver disease by ultrasound prior to enrollment
• Any patient with bleeding disorders or prolonged INR
• Abstinent or consuming less than two drinks of alcohol per day.
• Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).

Where it is running

• Sandra Boimbo — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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