Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071916
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2003-11-04
Brief Title:
Racial Difference in HCVHost Interactions
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
African American Response to Therapy for Hepatitis C
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate a group of African Americans and Caucasians with hepatitis C virus HCV compare their response rates to combination treatment with pegylated interferon alfa-2b and ribavirin and identify possible causes for racial differences in response to therapy The study will enroll a total of 260 participants age 18 or older over a 10 period In the next 5 years 132 subjects will be studied locally including 112 African Americans and 20 Caucasians Participants will be recruited from the clinical practices of the hepatologists liver doctors at the University of Tennessee Health Science Center and will also be selected from referrals at local hepatology clinics and the Memphis VA Hospital Volunteers will be treated with pegylated interferon alfa-2b injections once weekly and oral ribavirin 2 times a day for up to 72 weeks Study procedures include multiple blood draws Participants may be involved in study related procedures for up to 72 weeks
Detailed Description:
The University of Tennessee Health Science Center UTHSC Memphis Hepatitis C Cooperative Research Center was established in 2000 to support clinical and basic research in understanding the basis for chronic disease in hepatitis C HCV infection and response to therapy in clinically infected patients The primary research goal is to understand why African American AA patients with chronic hepatitis C are more susceptible to chronic infection and why their response rate to combination therapy is only 50 percent or less of that for non AA patients The present study will support this ongoing work by continuing to provide clinical samples from patients with chronic hepatitis C who are undergoing treatment The specific aims for the 2005-2010 Hepatitis C Cooperative Research Center are to determine how human leukocyte antigen HLA class II-dependent immune regulation and T cell specificities affect differences in immune responses to HCV and response to therapy in AA patients compared to non AA patients to determine if there is a difference in interferon-induced signaling between patients that respond to therapy and those that do not and to measure and compare the sustained virologic response to standard treatment for hepatitis C between AA and non AA patients Researchers plan to continue enrollment of patients to the African American Response to Therapy for Hepatitis C study 112 African American patients and 20 Caucasian patients in order to meet the current specific aims Participants will include adult African American and Caucasian patients with compensated chronic hepatitis C who have not been previously treated with interferon andor ribavirin Patients meeting the entry criteria will be enrolled The total number of patients to be enrolled is 260 over a 10-year period In the next 5 years 132 subjects 112 African American 20 Caucasian will be studied locally Patients will be recruited primarily from the clinical practices of the hepatologists at UTHSC Patients will also be selected from referrals at local Gastroenterology Hepatology clinics and the Memphis Department of Veterans Affairs VA Hospital Patients will be treated with weight based pegylated interferon alfa-2b once weekly and weight based ribavirin twice a day Duration of treatment with both pegylated interferon alfa-2b and ribavirin will be for up to 72 weeks Treatment will be discontinued at 24 weeks if there is persistent viremia and the patient wishes to discontinue therapy Ribavirin will be administered orally at a dose of 13 - 2 mgkg per day twice daily with 200 mg capsules Pegylated interferon alpha-2b will be administered by the subcutaneous route
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None