Status:
COMPLETED
Study of the Immune Response to Hepatitis C Virus
Lead Sponsor:
Rockefeller University
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to investigate the mechanism of a successful immune response to hepatitis C virus (HCV) infection. Currently, it is believed that the immune system is involved in respondi...
Detailed Description
Hepatitis C virus (HCV) infects approximately 200 million people worldwide. About 30% of infected individuals do not require treatment to clear the virus, but the remainder can become chronically infe...
Eligibility Criteria
Inclusion
- Patients with confirmed HCV infection based on serologic studies and/or plasma HCV titers
- Individuals who have recovered from toxicity of any prior therapy and who have not had IFN-α and/or ribavirin therapy in the last 6 months
- Performance status: Karnofsky 70-100%
- Life expectancy of at least 12 months
- Hematology laboratory results of:
- WBC greater than 3,800/mm3
- Absolute lymphocytes greater than 1,500/mm3
- Platelets greater than 120,000/mm3
- Hb at least 9.5 g/dl
- INR \< 1.5 IU
Exclusion
- Patients who are currently on immunotherapy
- Individuals who are currently on antibiotics
- Individuals who have had chemotherapy within the last year for other medical conditions
- Individuals who have had corticosteroid treatment or radiotherapy within the last 4 weeks
- Individuals infected with HIV, syphilis or hepatitis B or with other serious uncontrolled medical illness
- People with currently active second malignancy other than non-melanoma skin cancer
- No history of vasculitis
- No alcohol or drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- No patients with decompensated cirrhosis
- No NYHA class III/IV status
- No severe debilitating pulmonary disease
- No psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements
Key Trial Info
Start Date :
April 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00237432
Start Date
April 1 2003
End Date
February 1 2008
Last Update
December 10 2010
Active Locations (1)
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1
Rockefeller University Hospital
New York, New York, United States, 10021