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Hepatitis C Antiviral Resistance in African-Americans Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Hepatitis C Antiviral Resistance in African-Americans conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Hepatitis C Antiviral Resistance in African-Americans Clinical research trials and Hepatitis C Antiviral Resistance in African-Americans healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Hepatitis C Antiviral Resistance in African-Americans. Hepatitis C Antiviral Resistance in African-Americans Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Hepatitis C Antiviral Resistance in African-Americans clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Hepatitis C Antiviral Resistance in African-Americans condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Hepatitis C Antiviral Resistance in African-Americans  Hepatitis C Antiviral Resistance in African-Americans
Hepatitis C Antiviral Resistance in African-Americans
For Condition: Hepatitis C
Status: No longer recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 400
Location and Contact Information:
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
United States
University of Miami School of Medicine
Miami, Florida, 33136
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Rush University
Chicago, Illinois, 60612
United States
New York-Presbyterian Medical Center
New York City, New York, 10032
United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Additional Information:
Study ID Numbers: Virahep-C; U01 DK60329
Study Start Date: August 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038974
Other Hepatitis C Studies:
1. Effect of a Change in HIV Therapy on Liver Steatosis, Inflammation, and Fibrosis
2. A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection
3. Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV
4. Treatment of Cholestatic Pruritus With Sertraline
5. To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI).
Related Studies:
Other Hepatitis C Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
Hepatitis C Antiviral Resistance in African-Americans
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