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Phase I-II Vaccination of Autologous Dendritic Cells Transduced With Adenoviral Vector Encoding NS3 in Hepatitis C Encoding NS3 in Hepatitis C

Primary Purpose

Hepatitis C, Chronic

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Autologous dendritic cells transduced with Ad encoding NS3
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Chronic hepatitis C (genotype 1b) that had previously failed Interferon/Ribavirin-based treatment

Exclusion Criteria:

Liver cirrhosis HBV-coinfection Bilirubin >1.5 times ULN or ALT >7 ULN Hepatocellular carcinoma Immunodeficiency

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single arm

    Arm Description

    Autologous dendritic cells transduced with Ad encoding NS3

    Outcomes

    Primary Outcome Measures

    Safety and tolerability determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound.
    Safety assessment will be determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound.

    Secondary Outcome Measures

    Efficacy on viral load and immune response

    Full Information

    First Posted
    November 18, 2014
    Last Updated
    October 23, 2017
    Sponsor
    Clinica Universidad de Navarra, Universidad de Navarra
    Collaborators
    Centro de Investigación Médica Aplicada (CIMA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02309086
    Brief Title
    Phase I-II Vaccination of Autologous Dendritic Cells Transduced With Adenoviral Vector Encoding NS3 in Hepatitis C Encoding NS3 in Hepatitis C
    Official Title
    Phase I-II Vaccination Clinical Trial in Patients With Chronic Hepatitis C by Administration of Autologous Dendritic Cells Transduced With an Adenoviral Vector Encoding NS3 Protein
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Terminated
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    May 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Clinica Universidad de Navarra, Universidad de Navarra
    Collaborators
    Centro de Investigación Médica Aplicada (CIMA)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Dendritic cells (DC) play a central role in the activation of T-cell responses and have shown to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this study is to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype 1 HCV patients using autologous DC transduced with a recombinant adenovirus encoding NS3

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single arm
    Arm Type
    Experimental
    Arm Description
    Autologous dendritic cells transduced with Ad encoding NS3
    Intervention Type
    Biological
    Intervention Name(s)
    Autologous dendritic cells transduced with Ad encoding NS3
    Intervention Description
    Patients will receive 3 different dosis of the vaccine via subcutaneous injection
    Primary Outcome Measure Information:
    Title
    Safety and tolerability determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound.
    Description
    Safety assessment will be determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Efficacy on viral load and immune response
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic hepatitis C (genotype 1b) that had previously failed Interferon/Ribavirin-based treatment Exclusion Criteria: Liver cirrhosis HBV-coinfection Bilirubin >1.5 times ULN or ALT >7 ULN Hepatocellular carcinoma Immunodeficiency

    12. IPD Sharing Statement

    Learn more about this trial

    Phase I-II Vaccination of Autologous Dendritic Cells Transduced With Adenoviral Vector Encoding NS3 in Hepatitis C Encoding NS3 in Hepatitis C

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