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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532907
• Other study ID #: 14-1794
• Secondary ID: UL1TR001082
• Status: Completed
• Start date: August 2015
• Est. completion date: July 10, 2018

Study information

• Verified date: September 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This study is designed to obtain and store samples of serum and liver tissue in HCV-infected patients being treated with DAA therapy.

A liver biopsy will be performed pre-treatment for research reasons. A small liver sample that is not required for pathologic analysis will also be stored. Patients will undergo another liver biopsy at either 4 or 12 weeks after initiation of DAA therapy.

Any patients with HCV-related liver disease (age > 18) will be considered for this study.

Patients will have a 120 ml blood draw for research purposes at baseline and 12 weeks after stopping DAA treatment along with a 60 ml blood draw at 2, 4, 8, and 12 weeks of treatment.

The liver biopsy at baseline and then either at 4 or 12 weeks will be examined using molecular techniques to measure transcription of key genes involved in the antiviral response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 10, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria

• Signed informed consent

• Ages 18-70

• HCV-infected patients being treated with direct-acting antiviral (DAA) therapy.

Exclusion Criteria

• 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).

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Procedure:
• Liver Biopsy
patients will get a research liver biopsy pre-DAA treatment and either 4 or the standard 12 week time point. The liver biopsy is performed using standard protocol with ultrasound guidance.

Locations

Country	Name	City	State
United States	Sandra Boimbo	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (1)

Golden-Mason L, Palmer B, Klarquist J, Mengshol JA, Castelblanco N, Rosen HR. Upregulation of PD-1 expression on circulating and intrahepatic hepatitis C virus-specific CD8+ T cells associated with reversible immune dysfunction. J Virol. 2007 Sep;81(17):9249-58. Epub 2007 Jun 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gene array from baseline to either 4 or 12 weeks after treatment.	To examine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood.	1 year