Study of the Immune Response to Hepatitis C Virus
HCV Pathogenesis and Dendritic Cell Immunobiology
1 other identifier
observational
11
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 10, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedDecember 10, 2010
December 1, 2010
October 10, 2005
December 9, 2010
Conditions
Eligibility Criteria
Subjects with confirmed HCV infection recruited from the NYC metropolitan area
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rockefeller University Hospital
New York, New York, 10021, United States
Biospecimen
White blood cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles M. Rice, PHD
Rockefeller University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 10, 2005
First Posted
October 12, 2005
Study Start
April 1, 2003
Study Completion
February 1, 2008
Last Updated
December 10, 2010
Record last verified: 2010-12