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Dendritic cell immunotherapy in hepatitis C virus (HCV)-infected individuals.

Safety and efficacy of dendritic cell immunotherapy in patients with hepatitis C virus infection.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001134910
Enrollment
6
Registered
2011-10-31
Start date
2008-01-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study will examine the possibility that dendritic cell immunotherapy might increase HCV-specific cell mediated immunity with a concomitant decrease in the viral load, or even viral clearance.

Interventions

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 canc

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.

Sponsors

Eric J Gowans
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

HCV RNA positive for >6 months. Previously failed interferon-based therapy. Infected with genotype 1.

Exclusion criteria

Evidence of liver infection with other hepatitis agents, viz. HAV, HBV. HIV infection. Evidence of autoimmunity.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026