Study of the Immune Response to Hepatitis C Virus

Completed

Conditions studied: Hepatitis C

In brief

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 responding to HCV infection, but how it is involved is not known. It is estimated that 30% of individuals infected with HCV are able to clear the virus without treatment, while 70% progress to chronic infectious. By studying the immune responses in these two populations, we, the researchers at Rockefeller University, hope to gain insight into the mechanisms of the immune response and develop new strategies for HCV therapy.

Key facts

Study ID

NCT00237432

Run by

Rockefeller University

People needed

11

Starts

2003-04-01

Expected to finish

2008-02-01

Last updated by the study team

2010-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rockefeller University Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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