Trial intelligence / Profile preview

Interferon-Induced Gene Expression in HCV (Caucasian vs African American)

NCT00324389Phase 2

Key facts

Status
Completed
Start
May 2006
Countries
1
Sponsor
National Institute of Allergy and Infectious Diseases
Modality
rProtein (Recombinant Protein), Biologic
Conditions
hepatitis C (HCV)
01

Overview

Phase 2, open-label trial of interferon alfa-2a in hepatitis C (HCV), sponsored by National Institute of Allergy and Infectious Diseases. Started May 2006; status: completed.

02

Design

Study design
Non-randomizedOpen-label
03

Registry description

This proposal seeks to use DNA analyses to understand how racial and genetic factors influence interferon (treatment) response in HCV infection in African Americans. A better understanding should allow rational design of new therapies or better use of existing therapies. Patients will provide medical history and undergo a physical exam, blood draws, electrocardiogram, possible chest x-ray, and abdominal ultrasound. Patients will be admitted to the hospital for 5 days and undergo 2 liver biopsies, sedation, and multiple blood draws. Twenty adult male volunteers (10 Caucasians,10 African…

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