Hepatitis C
Conditions
Keywords
Hepatitis C, Interferon, Ribavirin, Efficacy, Viral load, Genetics, Cytokines, Immunology
Brief summary
This study is designed to test the hypothesis that African-Americans respond less well to combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not previously treated with either interferon or ribavirin. Reasons for differences in response, regardless of race, will be studied.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion: * Age between 18 and 70 years at screening * Black/African American or White/Caucasian * Born in the United States * Quantifiable Serum HCV RNA * Hepatitis C genotype 1 * Liver biopsy consistent with chronic hepatitis C * Negative urine pregnancy test * Males and Females must be using two reliable forms of effective contraception while on drug and during follow-up. Exclusion: * Previous treatment with interferon or ribavirin * Positive test at screening for anti-HIV * Positive test for HBsAg * Alcohol consumption of more than two drinks/day * History of other chronic liver disease * Pregnant or breast-feeding women * Male partners of women who are pregnant or contemplating pregnancy * Neutrophil count \<1000 cells/mm3 * Hgb \<11 g/dl in women or 12 g/dl in men * Platelet count \<75,000 cells/mm3. * Thalassemia, spherocytosis, history of GI bleeding or those at increased risk of anemia * Serum creatinine level \>1.5 times the upper limit of normal at screening or CrCl \< 75cc/min * Current dialysis * Alcohol or drug abuse within 6 months * Current (\<6 months)severe psychiatric disorder * History of immunologically mediated disease * Decompensated liver disease * High risk cardiovascular/coronary artery disease * Severe seizure disorder or anticonvulsant use * Solid organ or bone marrow transplantation * Thyroid disease poorly controlled on prescribed medications * History or other evidence of retinopathy * Chronic use of oral steroids * Inability or unwillingness to provide informed consent or abide by the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virologic Response (SVR) | 24 weeks after therapy is discontinued | The primary end point of therapy was an SVR that was definied as the absences of detectable HCV RNA in serum 24 weeks after therapy was stopped. |
Countries
United States