Hepatitis C Antiviral Resistance in African-Americans

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038974
• Other study ID #: Virahep-C (completed)
• Secondary ID: U01DK060329U01DK
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2002
• Last updated: August 2, 2017
• Start date: August 2002
• Est. completion date: November 2005

Study information

• Verified date: August 2017
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: November 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• peginterferon alfa-2a

• Ribavirin

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Rush University	Chicago	Illinois
United States	University of Miami School of Medicine	Miami	Florida
United States	New York-Presbyterian Medical Center	New York	New York
United States	University of California, San Francisco	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Hoffmann-La Roche, National Cancer Institute (NCI), National Center for Advancing Translational Science (NCATS), National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Conjeevaram HS, Fried MW, Jeffers LJ, Terrault NA, Wiley-Lucas TE, Afdhal N, Brown RS, Belle SH, Hoofnagle JH, Kleiner DE, Howell CD; Virahep-C Study Group. Peginterferon and ribavirin treatment in African American and Caucasian American patients with hep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virologic Response (SVR)	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.	24 weeks after therapy is discontinued