Hepatitis C, ChronicNCT01062659
Cellular Immune Responses in the Liver in Chronic Hepatitis C (CHC) Patients
An observational study of Hepatitis C, Chronic and Liver Diseases, run by University of Ulm at 1 site in Germany.
Trial summary
In order to persist in the liver, HCV has numerous nonspecific and specific strategies to overcome the immunity of the host. The crucial step in the establishment of viral persistence and chronic hepatitis is the avoidance of specific antiviral cellular immune response in the liver. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic, Liver Diseases, Virus Diseases
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Mar 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patient with established chronic hepatitis C presented to the liver unit of the outpatient clinic how are eligible to antiviral therapy.
Who may be able to join
- proven chronic hepatitis C
- aged between 18 and 65
- willingness to give written informed consent to the study protocol
Who cannot join
- history of having received any IFN, PEG-IFN or RBV
- not eligible for antiviral treatment with peginterferon and ribavirin by standard of care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Cellular Immune Responses in the Liver in Patients With Chronic Hepatitis C Virus Infection
In order to persist in the liver, HCV has numerous nonspecific and specific strategies to overcome the immunity of the host. The crucial step in the establishment of viral persistence and chronic hepatitis is the avoidance of specific antiviral cellular immune response in the liver. Treatment with pegylated interferon alpha (IFNα) in combination with ribavirin (RBV) is the standard therapy for chronic hepatitis C is. The response to IFNα / RBV therapy depends on the effective cellular antiviral immune response in the liver. The understanding of the interaction between HCV and cellular immune response is important for the effective use of existing diagnostic techniques, the Individual control and adjustment of the current therapeutic approaches and the development of future therapeutic and immunization strategies. In this study, the investigators want to investigate cellular Immune responses in the liver of HCV infected patients and characterize the influence of these immune responses to the response to IFNα / RBV therapy.
- Conditions
- Hepatitis C, Chronic, Liver Diseases, Virus Diseases
- Keywords
- HCV, hepatitis C virus, CHC, chronic hepatitis c, interferon, ribavirin, Hepatitis, Viral, Human, Anti-Infective Agents, peginterferon alfa-2a, peginterferon alfa-2b
- Medical subject headings
- Hepatitis C, Chronic, Liver Diseases, Virus Diseases, Hepatitis C, Hepatitis, Viral, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic Hepatitis C | Patients with chronic Hepatitis C (CHC) Genotype 1-4 who are naive to antiviral treatment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dietmar M. Klass, University of Ulm
- Investigators
- Dietmar M Klass, MD, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062659
- Sponsor's protocol ID
- TCell
- Status last verified
- Mar 2014
- First submitted
- 3 Feb 2010
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Cellular Immune Responses in the Liver in Patients With Chronic Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT01062659
- Acronym / sponsor ID
- TCell
- Conditions
- Hepatitis C, Chronic, Liver Diseases, Virus Diseases
- Keywords
- HCV, hepatitis C virus, CHC, chronic hepatitis c, interferon, ribavirin, Hepatitis, Viral, Human, Anti-Infective Agents
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 4 Feb 2010 (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.
In order to persist in the liver, HCV has numerous nonspecific and specific strategies to overcome the immunity of the host. The crucial step in the establishment of viral persistence and chronic hepatitis is the avoidance of specific antiviral cellular immune response in the liver. Treatment with pegylated interferon alpha (IFNα) in combination with ribavirin (RBV) is the standard therapy for chronic hepatitis C is. The response to IFNα / RBV therapy depends on the effective cellular antiviral immune response in the liver. The understanding of the interaction between HCV and cellular immune response is important for the effective use of existing diagnostic techniques, the Individual control and adjustment of the current therapeutic approaches and the development of future therapeutic and immunization strategies. In this study, the investigators want to investigate cellular Immune responses in the liver of HCV infected patients and characterize the influence of these immune responses to the response to IFNα / RBV therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic Hepatitis C | – | –Patients with chronic Hepatitis C (CHC) Genotype 1-4 who are naive to antiviral treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient with established chronic hepatitis C presented to the liver unit of the outpatient clinic how are eligible to antiviral therapy.
Key inclusion criteria (3 listed)
- proven chronic hepatitis C
- aged between 18 and 65
- willingness to give written informed consent to the study protocol
Key exclusion criteria (2 listed)
- history of having received any IFN, PEG-IFN or RBV
- not eligible for antiviral treatment with peginterferon and ribavirin by standard of care
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
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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.
Dietmar M Klass, MD principal investigator
University of Ulm
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, Chronic and Liver Diseases, run by University of Ulm 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 1 Apr 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 1 Apr 2014.