NCT02309086

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2011

Typical duration for phase_1

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

November 18, 2014

Last Update Submit

October 23, 2017

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • Efficacy on viral load and immune response

    6 months

Study Arms (1)

Single arm

EXPERIMENTAL

Autologous dendritic cells transduced with Ad encoding NS3

Biological: Autologous dendritic cells transduced with Ad encoding NS3

Interventions

Autologous dendritic cells transduced with Ad encoding NS3BIOLOGICAL

Patients will receive 3 different dosis of the vaccine via subcutaneous injection

Single arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

December 5, 2014

Study Start

May 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2014

Last Updated

October 24, 2017

Record last verified: 2017-10