A novel cell therapy to treat patients with hepatitis C virus (HCV)infection.

Safety and efficacy of cell immunotherapy to treat hepatitis C virus (HCV) infection

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000067077

Enrollment

Registered

2010-01-20

Start date

2011-01-01

Completion date

2011-12-30

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 is designed to examine the hypothesis that increasing the level of specific immunity to the proteins of hepatitis C virus will result in a reduction in the viral load and/or clearance of the virus.

Interventions

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.

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 70 Years

Healthy volunteers

Inclusion criteria

HCV ribonuclei acid (RNA) positive for >6 months. Previously failed interferon-based therapy Infected with genotype 1 virus.

Exclusion criteria

Hepatitis B virus (HBV)-positive Human immunodeficiency virus (HIV)-positive Evidence of autoimmunity

Outcome results