Study of Hepatic Responses in Patients Receiving Direct-acting Anti-HCV Drugs
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 9/21/2018 |
| Start Date: | August 2015 |
| End Date: | July 10, 2018 |
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.
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.
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.
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.
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).
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