Immune Monitoring of Hepatitis C Under DAA Therapy

Hepatitis C Clinical Trial

— IMHC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02904603
• Other study ID #: IM-HC-1516
• Status: Recruiting
• Phase: N/A
• First received: September 6, 2016
• Last updated: September 20, 2016
• Start date: November 2014
• Est. completion date: January 2017

Study information

• Verified date: September 2016
• Source: University of Regensburg
• Contact: Georg Peschel
• Phone: 00499419447012
• Email: georg.peschel[@]ukr.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
Germany	University of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of IP10 and related cytokines during treatment (ng/ml)	Screening for Biomarkers under DAA Therapy until timepoint SVR 12 (12 weeks treatment plus control 12 weeks after end of Treatment = 24 weeks)	24 weeks (observation time under and after DAA therapy)	No
Secondary	SVR 12	Eradication of HCV RNA 12 weeks after end of Treatment (Treatment 12 weeks)	24 weeks (12 weeks treatment plus control 12 weeks after end of treatment)	No
Secondary	Change of inflammatory markers (ferritin ng/ml, CRP mg/l, PCT ng/ml) during treatment		24 weeks (observation time under DAA therapy)