- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00237432
Study of the Immune Response to Hepatitis C Virus
HCV Pathogenesis and Dendritic Cell Immunobiology
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 infected with HCV. Both resolution and protection correlate with the presence of HCV-specific T cells responses. The researchers believe that dendritic cells (DCs) play a role in determining how T-cells respond to the virus. They believe that the virus is able to modify the function of these cells causing the inactivation of T cells that would otherwise react with the virus. By characterizing the phenotype and function of DCs in both the patients who spontaneously resolve the infection and patients who become chronically infected the investigators hope to learn more about the pathogenesis of HCV.
People interested in participating in this study will have a complete history and general medical examinations before beginning the study. Testing for communicable diseases, including hepatitis B, syphilis and HIV will be done. If a disease is found you will be informed and offered counseling.
Following the screening, you will have a procedure called leukapheresis, in which white blood cells are removed, but your own red blood cells are returned. The procedure takes approximately 3 hours and is similar to blood donation. The leukapheresis is done during a same day admission to the hospital by an outside blood collection company with trained nurses and certified equipment.
Some aspects of this study are experimental which means the fluid and cells collected will be studied and analyzed to determine more precisely how your body's immune system is responding to the virus. These tests are experimental in that they are not part of the usual routine care of patients.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10021
- Rockefeller University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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 Criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Charles M. Rice, PHD, Rockefeller University
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Inizio studio
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CRI-0505
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .