Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001134910
Ethics application status
Approved
Date submitted
31/10/2011
Date registered
31/10/2011
Date last updated
31/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dendritic cell immunotherapy in hepatitis C virus (HCV)-infected individuals.
Scientific title
Safety and efficacy of dendritic cell immunotherapy in patients with hepatitis C virus infection.
Secondary ID [1] 273296 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C virus infection. 279067 0
Condition category
Condition code
Oral and Gastrointestinal 279256 279256 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 279258 279258 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dendritic cell immunotherapy to elicit HCV-specific cell mediated immunity in patients who have previously failed interferon-based therapy. The dose will vary from 1 dose unit (DU) representing 10 million, HCV-specific peptide pulsed monocyte-derived dendritic cells, to 5 DU on 1, 2 or 3 occasions at weekly intervals.
As this trial was a first in man, the dose variation was decided after consultation with the Therapeutic Goods Administration and was based on previous dendritic cell therapy cancer trials as follows:

Patient #1-1 DU by the intravenous route and 1DU by the intradermal route.

Patient #2-1DU by the intravenous route on 2 occasions, two weeks apart, accompanied by 1DU by the intradermal route on both occasions.

Patient #3-1DU followed by 2DU and 5DU at 2 weekly intervals by the intravenous route, accompanied by 1DU by the intradermal route at each time point.

Patient #4-1DU followed by 5DU at 2 weekly intervals by the intravenous route, accompanied by 1DU by the intradermal route at each time point.

Patient #5-2DU on 3 occasions, 2 weeks apart by the intravenous route, accompanied by 1DU by the intradermal route at each time point.

Patient #6-2DU on 3 occasions, 2 weeks apart by the intradermal route.
Intervention code [1] 283643 0
Treatment: Other
Comparator / control treatment
Patients will represent their own control as the viral load and immunological measures will be studied before and after intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279878 0
Product safety, as determined by:
*Clinical examination.
*Full blood examination.
*Clinical chemistry including liver function tests.
Timepoint [1] 279878 0
Weekly during intervention and for 6 weeks after final dose.
Secondary outcome [1] 294664 0
Viral load will be assessed by reverse-transcriptase polymerase chain reaction (RT-PCR).
Timepoint [1] 294664 0
Weekly during intervention and for 6 weeks after final dose.

Eligibility
Key inclusion criteria
HCV RNA positive for >6 months.
Previously failed interferon-based therapy.
Infected with genotype 1.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of liver infection with other hepatitis agents, viz. HAV, HBV.
HIV infection.
Evidence of autoimmunity.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be enrolled by the clinician who provides care on a routine basis. The trial will be discussed during a normal appointment in the liver clinic, and the patient will be provided with a patient information and consent form. The consent form must be signed in the clinic in the presence of the liver specialist.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The trial is a dose escalation trial.
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4668 0
3001

Funding & Sponsors
Funding source category [1] 284124 0
Government body
Name [1] 284124 0
National Institutes of Health
Country [1] 284124 0
United States of America
Primary sponsor type
Individual
Name
Eric J Gowans
Address
Burnet Institute
GPO Box 2284
Melbourne, VIC 3001
Country
Australia
Secondary sponsor category [1] 269086 0
None
Name [1] 269086 0
Address [1] 269086 0
Country [1] 269086 0
Other collaborator category [1] 252320 0
Hospital
Name [1] 252320 0
Alfred Hospital
Address [1] 252320 0
Commercial Road
Melbourne, VIC 3001
Country [1] 252320 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272083 0
AMREP (Alfred Medical Research and Education Precinct.
Ethics committee address [1] 272083 0
Ethics committee country [1] 272083 0
Australia
Date submitted for ethics approval [1] 272083 0
31/01/2005
Approval date [1] 272083 0
30/06/2007
Ethics approval number [1] 272083 0
1/05/0227

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33329 0
Address 33329 0
Country 33329 0
Phone 33329 0
Fax 33329 0
Email 33329 0
Contact person for public queries
Name 16576 0
Bruce Loveland
Address 16576 0
Burnet Institute
GPO Box 2284
Melbourne, VIC 3001
Country 16576 0
Australia
Phone 16576 0
613 9282 2221
Fax 16576 0
613 9282 2111
Email 16576 0
[email protected]
Contact person for scientific queries
Name 7504 0
Eric J Gowans
Address 7504 0
Burnet Institute
GPO Box 2284
Melbourne. VIC 3001
Country 7504 0
Australia
Phone 7504 0
61 422 928 906
Fax 7504 0
613 9282 2111
Email 7504 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.