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The Role of Dendritic Cells in Hepatitis C Infection

Primary Purpose

Chronic Hepatitis C Infection

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Viraferon-peg and Rebetol
Sponsored by
University College, London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Hepatitis C Infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • anti-HCV positive
  • HCV RNA positive

Exclusion Criteria:

  • contraindications for antiviral treatment
  • concurrent chronic viral infections

Sites / Locations

  • University College Hospital

Outcomes

Primary Outcome Measures

Basic science research (immunology of hepatitis C)in hepatitis c patients receiving established, standard antiviral treatment (pegylated Interferon+Ribavirin)

Secondary Outcome Measures

Full Information

First Posted
July 24, 2008
Last Updated
July 24, 2008
Sponsor
University College, London
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00723242
Brief Title
The Role of Dendritic Cells in Hepatitis C Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University College, London
Collaborators
Schering-Plough

4. Oversight

5. Study Description

Brief Summary
The role of the dendritic cells, the most potent antigen presenting cells, in the establishment of chronic hepatitis C is not established. The study aims to define whether the dendritic cells are affected by the hepatitis C virus and whether that bears an impact on the antiviral immune response they generate. The hypothesis is explored by investigating a group of patients prior to and after the initiation of standard treatment for hepatitis C with pegylated Interferon and Ribavirin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Infection

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Viraferon-peg and Rebetol
Primary Outcome Measure Information:
Title
Basic science research (immunology of hepatitis C)in hepatitis c patients receiving established, standard antiviral treatment (pegylated Interferon+Ribavirin)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: anti-HCV positive HCV RNA positive Exclusion Criteria: contraindications for antiviral treatment concurrent chronic viral infections
Facility Information:
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom

12. IPD Sharing Statement

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The Role of Dendritic Cells in Hepatitis C Infection

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