Hepatitis C Antiviral Resistance in African-Americans - Tabular View

Tracking Information
First Received Date ^ICMJE	June 5, 2002
Last Updated Date	October 11, 2005
Start Date ^ICMJE	August 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00038974 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Hepatitis C Antiviral Resistance in African-Americans
Official Title ^ICMJE	Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C)
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Condition ^ICMJE	Hepatitis C
Intervention ^ICMJE	Drug: Pegylated interferon Drug: Ribavirin
Study Arms / Comparison Groups
Publications *	Dove LM, Rosen RC, Ramcharran D, Wahed AS, Belle SH, Brown RS, Hoofnagle JH; Virahep-C Study Group. Decline in male sexual desire, function, and satisfaction during and after antiviral therapy for chronic hepatitis C. Gastroenterology. 2009 Sep;137(3):873-84, 884.e1. Epub 2009 Jun 13. Hoofnagle JH, Wahed AS, Brown RS Jr, Howell CD, Belle SH; Virahep-C Study Group. Early changes in hepatitis C virus (HCV) levels in response to peginterferon and ribavirin treatment in patients with chronic HCV genotype 1 infection. J Infect Dis. 2009 Apr 15;199(8):1112-20. Cannon NA, Donlin MJ, Fan X, Aurora R, Tavis JE; Virahep-C Study Group. Hepatitis C virus diversity and evolution in the full open-reading frame during antiviral therapy. PLoS ONE. 2008 May 7;3(5):e2123.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	400
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00038974
Responsible Party
Study ID Numbers ^ICMJE	Virahep-C, U01 DK60329
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	October 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP