Immune Monitoring of Hepatitis C Under DAA Therapy

Prospective Monitoring of Immune Parameters in Patients With Hepatitis C Under Treatment With Direct Acting Antivirals

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02904603

Acronym

IMHC

Enrollment

100

Registered

2016-09-19

Start date

2014-11-30

Completion date

2017-01-31

Last updated

2016-09-21

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

Conditions

Hepatitis C

Brief summary

Direct acting antivirals offer a new opportunity to monitor the immune response in Hepatitis C infection. In this study cytokine markers will be measured during therapy up to time point SVR 12 an correlated to clinical Parameters and regular laboratory findings.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* written consent, age, HCV-RNA positive, DAA therapy

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Change of IP10 and related cytokines during treatment (ng/ml)	24 weeks (observation time under and after DAA therapy)	Screening for Biomarkers under DAA Therapy until timepoint SVR 12 (12 weeks treatment plus control 12 weeks after end of Treatment = 24 weeks)

Secondary

Measure	Time frame	Description
SVR 12	24 weeks (12 weeks treatment plus control 12 weeks after end of treatment)	Eradication of HCV RNA 12 weeks after end of Treatment (Treatment 12 weeks)
Change of inflammatory markers (ferritin ng/ml, CRP mg/l, PCT ng/ml) during treatment	24 weeks (observation time under DAA therapy)	—

Countries

Germany

Contacts

Primary ContactGeorg Peschel

georg.peschel@ukr.de00499419447012

Backup ContactKilian Weigand

kilian.weigand@ukr.de00499419447012

Outcome results