Immune Monitoring of Hepatitis C Under DAA Therapy
IMHC
Prospective Monitoring of Immune Parameters in Patients With Hepatitis C Under Treatment With Direct Acting Antivirals
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 6, 2016
CompletedFirst Posted
Study publicly available on registry
September 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedSeptember 21, 2016
September 1, 2016
2 years
September 6, 2016
September 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (2)
SVR 12
24 weeks (12 weeks treatment plus control 12 weeks after end of treatment)
Change of inflammatory markers (ferritin ng/ml, CRP mg/l, PCT ng/ml) during treatment
24 weeks (observation time under DAA therapy)
Eligibility Criteria
Patients under DAA therapy \> 18 years monocentral.
You may qualify if:
- written consent, age, HCV-RNA positive, DAA therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Regensburg
Regensburg, 93047, Germany
Related Publications (2)
Adenugba A, Hornung M, Weigand K, Peschel G, Junger H, Kupke P, Lang H, Marquardt JU, Zimmermann T, Geissler EK, Schlitt HJ, Werner JM. Ribavirin Improves NK Cell IFNgamma Response During Sofosbuvir-based DAA Therapy in HCV-infected Liver Transplant Recipients. Transplantation. 2021 Oct 1;105(10):2226-2238. doi: 10.1097/TP.0000000000003612.
PMID: 33587435DERIVEDHutchinson JA, Weigand K, Adenugba A, Kronenberg K, Haarer J, Zeman F, Riquelme P, Hornung M, Ahrens N, Schlitt HJ, Geissler EK, Werner JM. Predicting Early Viral Control under Direct-Acting Antiviral Therapy for Chronic Hepatitis C Virus Using Pretreatment Immunological Markers. Front Immunol. 2018 Feb 7;9:146. doi: 10.3389/fimmu.2018.00146. eCollection 2018.
PMID: 29467758DERIVED
Biospecimen
Serum probes
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kilian Weigand
Uiversity of Regensburg
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med.
Study Record Dates
First Submitted
September 6, 2016
First Posted
September 19, 2016
Study Start
November 1, 2014
Primary Completion
November 1, 2016
Study Completion
January 1, 2017
Last Updated
September 21, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share