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Racial Differences in Hepatitis C Virus (HCV)/Host Interactions



Racial Differences in Hepatitis C Virus (HCV)/Host Interactions

For Condition: Hepatitis C
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of the research study is to evaluate a group of African Americans and Caucasians with hepatitis C virus (HCV) infection and compare their response rates to treatment with a combination of pegylated interferon and ribavirin.
Details: The purpose of this study is to identify causes for racial differences in response to therapy for treatment of HCV. This will involve examining differences between racial groups in the hepatitis virus, how the body processes the medications and the genetic makeup of persons. The patients will be taking standard treatment - a combination of pegylated interferon alpha 2b and ribavirin for either 24 or 48 weeks. Clinic visits and blood samples will be at study entry and 1, 2, 4 and 8 weeks after beginning treatment and then once a month until medication is stopped. Subjects will have clinic visits for 6 months after completion of therapy.
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Uncontrolled, Single Group Assignment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Adult, male or female, African American or Caucasian, age of 18 or older and never been treated wtih interferon or ribavirin. - Serum positive for hepatitis C virus by PCR or other assays (e.g., bDNA). - Liver biopsy within 2 years of entry to protocol. - Compensated liver disease with the laboratory parameters: Hemoglobin values of >= 12gm/dL for females OR >= 13gm/dL for males; Neutrophil count >= 1500/mm3; platelets >= 85000/mm3; Albumin > 3.0 mg/dL; serum creatinine <=1.4 mg/dL; Thyroid stimulating hormone within normal limits of thyroid disease under control. EXCLUSION CRITERIA: - Hypersensitivity to alpha interferon or ribavirin. - Hemoglobinopathies. - Evidence of advanced liver disease. - Patients with evidence of ischemia. - Patients wtih clinically significant retinal abnormalities. - Active substance abuse, such as alcohol, intravenous (IV) and inhaled drugs. - Patients with history of organ transplantation. - Patients infected with HIV. - Preexisting severe psychiatric conditions.
Total Enrollment: 125

Location and Contact Information:

University of Tennessee Helath Science Ctr. *Recruiting*
Memphis,  Tennessee,  38163
United States
Recruiting  


Additional Information:
Study ID Numbers:  00-091; 
Study Start Date: March 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071916

Other Hepatitis C Studies:
1. 12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.

2. Treatment of Cholestatic Pruritus With Sertraline

3. Effects of Ribavirin on Zidovudine or Stavudine

4. Thymosin Plus PEG-Interferon in Hepatitis C Patients with Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin

5. Study of FK788 in Subjects with Chronic Hepatitis C Virus Infection

Related Studies:

Other Hepatitis C Clinical Trials
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