Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000067077
Ethics application status
Approved
Date submitted
15/01/2010
Date registered
20/01/2010
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel cell therapy to treat patients with hepatitis C virus (HCV)infection.
Scientific title
Safety and efficacy of cell immunotherapy to treat hepatitis C virus (HCV) infection
Secondary ID [1] 1299 0
NIL
Universal Trial Number (UTN)
U1111-1113-3407
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C virus infection 256555 0
Condition category
Condition code
Oral and Gastrointestinal 256723 256723 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 256772 256772 0 0
Other infectious diseases
Inflammatory and Immune System 256773 256773 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cell immunotherapy to elicit HCV-specific immune responses in patients who have previously failed interferon-based therapy.
The dose will vary from 10,000 to 100 million HCV antigen positive cells, administered by the intradermal route. Patients will receive these cell numbers in 1, 2 or 3 doses with one week between doses.
Intervention code [1] 255825 0
Treatment: Other
Intervention code [2] 255846 0
Other interventions
Comparator / control treatment
Patients will represent their own control as the viral load and immunological parameters will be studied before and after intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257610 0
Safety.
Clinical examination.
Haematology-full blood examination
Clinical chemistry-full study, including liver function tests (LFT).
HCV viral load.
Timepoint [1] 257610 0
Weekly during intervention and weekly for 6 weeks after intervention.
Secondary outcome [1] 262881 0
Induction of HCV-specific cell mediated immunity.
This will be assessed by Enzyme-linked immunosorbent spot (ELIspot) examination of peripheral blood mononuclear cells (PBMC) using HCV peptide pools as the stimulating antigen.
The viral load will be assessed by reverse transcriptase-polymerase chain reaction (RT-PCR).
Timepoint [1] 262881 0
Weekly during intervention and weekly for 6 weeks after intervention.

Eligibility
Key inclusion criteria
HCV ribonuclei acid (RNA) positive for >6 months.
Previously failed interferon-based therapy
Infected with genotype 1 virus.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hepatitis B virus (HBV)-positive
Human immunodeficiency virus (HIV)-positive
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)
The patients will be enrolled by a clinician who normally provides care. The trial will be discussed during a normal appointment in the liver clinic, the patient provided with a patient information and consent form (PICF) which he/she is encouraged to read and discuss with family/friends and/or their general practitioner. The consent form will be signed in the clinic in the presence of their liver specialist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be enrolled essentially as they appear in the clinic.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The trial will be 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
1/07/2010
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
30/12/2011
Date of last data collection
Anticipated
Actual
30/06/2012
Sample size
Target
15
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256319 0
Government body
Name [1] 256319 0
National Health and Medical Research Council (NHMRC)
Country [1] 256319 0
Australia
Primary sponsor type
Individual
Name
Eric J Gowans
Address
Burnet Institute
GPO Box 2284
Melbourne
VIC 3001
Country
Australia
Secondary sponsor category [1] 251636 0
None
Name [1] 251636 0
Address [1] 251636 0
Country [1] 251636 0
Other collaborator category [1] 1034 0
Hospital
Name [1] 1034 0
Alfred Hospital
Address [1] 1034 0
Dr Stuart Roberts
Dept of Gastroenterology
Commercial Road
Melbourne
VIC 3004
Country [1] 1034 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258403 0
Alfred Medical Research and Education Precinct (AMREP).
Ethics committee address [1] 258403 0
Ethics committee country [1] 258403 0
Australia
Date submitted for ethics approval [1] 258403 0
18/01/2010
Approval date [1] 258403 0
01/12/2010
Ethics approval number [1] 258403 0

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

Contacts
Principal investigator
Name 30709 0
Address 30709 0
Country 30709 0
Phone 30709 0
Fax 30709 0
Email 30709 0
Contact person for public queries
Name 13956 0
Bruce Loveland
Address 13956 0
Burnet Institute
GPO Box 2284
Melbourne
VIC 3001
Country 13956 0
Australia
Phone 13956 0
61 3 9282 2111
Fax 13956 0
61 3 9282 2100
Email 13956 0
[email protected]
Contact person for scientific queries
Name 4884 0
Eric Gowans
Address 4884 0
Burnet Institute
GPO Box 2284
Melbourne, VIC 3001
Country 4884 0
Australia
Phone 4884 0
61 8 8161 8541/61 422928906
Fax 4884 0
61 8 8239 0267
Email 4884 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.