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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00071916 |
Purpose
The purpose of the research study is to evaluate a group of African Americans and Caucasians with hepatitis C virus infection, compare their response rates to treatment with a combination of pegylated interferon and ribavirin, and to identify possible causes for racial differences in response to therapy.
| Condition | Intervention |
|---|---|
|
Hepatitis C |
Biological: Interferon Drug: Ribavirin |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | African American Response to Therapy for Hepatitis C |
| Estimated Enrollment: | 125 |
| Study Start Date: | March 2001 |
The purpose of this study is to identify causes for racial differences in response to therapy for treatment of the hepatitis C virus. This will involve examining differences between racial groups in the hepatitis virus, how the body processes the medications and the genetic make-up of persons. The patients will be taking standard treatment of hepatitis C - 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Compensated liver disease with the following laboratory parameters at the Entry visit:
Exclusion Criteria:
Contacts and Locations| Contact: Jacquelyn Fleckenstein | (901) 448-4384 | jffleckenste@utmem.edu |
| United States, Tennessee | |
| University of Tennessee Health Science Center | Recruiting |
| Memphis, Tennessee, United States, 38163 | |
More Information
| Study ID Numbers: | 00-091 |
| Study First Received: | November 4, 2003 |
| Last Updated: | September 13, 2005 |
| ClinicalTrials.gov Identifier: | NCT00071916 History of Changes |
| Health Authority: | United States: Federal Government |
|
Hepatitis C, African Americans |
|
Antimetabolites Anti-Infective Agents Liver Diseases RNA Virus Infections Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Antineoplastic Agents Interferons Ribavirin |
Hepatitis, Viral, Human Antiviral Agents Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Therapeutic Uses Hepatitis C |