Hepatitis C Antiviral Resistance in African-Americans

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborators: Hoffmann-La Roche; National Cancer Institute (NCI); National Center for Advancing Translational Science (NCATS); National Institute on Minority Health and Health Disparities (NIMHD)
• Treatments: Antiviral Agents; Interferons; Peginterferon alfa-2a; Ribavirin

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