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Hepatitis C Antiviral Resistance in African-Americans

Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00038974
Enrollment
401
Registered
2002-06-10
Start date
2002-08-31
Completion date
2005-11-30
Last updated
2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

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

DRUGpeginterferon alfa-2a
DRUGRibavirin

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
National Cancer Institute (NCI)
CollaboratorNIH
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
Hoffmann-La Roche
CollaboratorINDUSTRY
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Sustained Virologic Response (SVR)24 weeks after therapy is discontinuedThe 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026