Hepatitis CIMHCNCT02904603
Immune Monitoring of Hepatitis C Under DAA Therapy
An observational study of Hepatitis C, run by University of Regensburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatitis C
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients under DAA therapy > 18 years monocentral.
Who may be able to join
- written consent, age, HCV-RNA positive, DAA therapy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Regensburg
Regensburg, 93047
Georg Peschel, 00499419447012, georg.peschel@ukr.de
Kilian Weigand, 00499419447012, kilian.weigand@ukr.de
About this study
Official title: Prospective Monitoring of Immune Parameters in Patients With Hepatitis C Under Treatment With Direct Acting Antivirals
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.
- Conditions
- Hepatitis C
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 weeks (observation time under and after DAA therapy)
Secondary outcomes (2)
SVR 12
Eradication of HCV RNA 12 weeks after end of Treatment (Treatment 12 weeks)
Measured: 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
Measured: 24 weeks (observation time under DAA therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startNov 2014
- Primary completionNov 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Georg Peschel, University of Regensburg
- Investigators
- Kilian Weigand, Study chair, Uiversity of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904603
- Sponsor's protocol ID
- IM-HC-1516
- Acronym
- IMHC
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33587435Hutchinson 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.
PubMed 29467758
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monitoring of Immune Parameters in Patients With Hepatitis C Under Treatment With Direct Acting Antivirals
- ClinicalTrials.gov ID
- NCT02904603
- Acronym / sponsor ID
- IMHC / IM-HC-1516
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under DAA therapy > 18 years monocentral.
Key inclusion criteria (1 listed)
- written consent, age, HCV-RNA positive, DAA therapy
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of IP10 and related cytokines during treatment (ng/ml)
Time frame: 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)
2 secondary outcomes
SVR 12
Time frame: 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
Time frame: 24 weeks (observation time under DAA therapy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Derived from this study: PubMed 33587435Adenugba 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.
- Derived from this study: PubMed 29467758Hutchinson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kilian Weigand study chair
Uiversity of Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georg Peschel (00499419447012, georg.peschel@ukr.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of IP10 and related cytokines during treatment (ng/ml) (time frame: 24 weeks (observation time under and after DAA therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02904603, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016.