Impact of Immune Responses in Chronic Hepatitis C Genotype 1 Virus Infected Patients during Treatment with Peg-Interferon-alpha-2b and Ribavirin.

Impact of Immune Responses in Chronic Hepatitis C Genotype 1 Virus Infected Patients during Treatment with Peg-Interferon-alpha-2b and Ribavirin. - CIRES = hCv Immune RESponses

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30088

Enrollment

Registered

2006-09-12

Start date

2007-02-07

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

HCV hepatitis C

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Male and female patients between 18-70 years of age, with evidence of a chronic hepatitis C Genotype 1 infection. -No previous treatment with, peginterferon or conventional interferon plus ribavirin combination therapy. -Indication for antiviral therapy of hepatitis C according to current clinical guidelines. -Written informed consent.

Exclusion criteria

Exclusion criteria: •History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigator, unsuitable for the study. •Presence of contra-indications for antiviral therapy with interferon or antiviral therapy.

Design outcomes

Primary

Measure	Time frame
Outcome measurements Peripheral blood -Frequency, phenotype and function of HCV specific T cells. -Frequency, phenotype and function of Treg and DCs. -Determination of immunoregulatory cytokines in blood (Elispot or ELISA). Intrahepatic -Frequency, phenotype and function of intrahepatic Treg. -Determination of immuneregulatory cytokines in the liver (Elispot or ELISA).	—

Secondary

Measure	Time frame
No extra secundary outcome variables	—

Countries

Netherlands

Outcome results