Chronic Hepatitis CNCT00876174
Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C
An observational study of Chronic Hepatitis C, run by University of Nebraska.
Trial summary
The objective of this pilot project is to investigate the prognostic criteria for sensitivity of Chronic Hepatitis C (CHC) Genotype 1, patients to IFNa treatment. Signal transduction in peripheral blood mononuclear cell (PBMC) of control groups will be compared with that of CHC patients. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Blood sampling of peripheral blood mononuclear cells and Blood draw, 20ml peripheral blood mononuclear cells
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2009to 8 Jan 2010
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with genotype 1, chronic hepatitis C who are to undergo antiviral therapy and their healthy family member or significant other
Who may be able to join
- 19 years of age or older, of either gender
- History of chronic hepatitis C documented by HCVRNA or healthy family member/significant other
- Documented genotype 1 for hepatitis participants or no hepatitis infection for healthy control
- Subject prescribed antiviral therapy for hepatitis participants or none for healthy control
- Able to give informed consent
Who cannot join
- Under 19 years of age
- Unable to give informed consent
About this study
The objective of this pilot project is to investigate the prognostic criteria for sensitivity of Chronic Hepatitis C (CHC) Genotype 1, patients to IFNa treatment. Signal transduction in peripheral blood mononuclear cell (PBMC) of control groups will be compared with that of CHC patients. For this study, 20 patients with Hepatitis C virus (HCV) infection who are to undergo standard antiviral therapy and 10 healthy donors (significant others of the HCV subject) will be enrolled. Signal transduction will be studied in peripheral blood of CHC subjects before the treatment, after 1 and 3 months of treatment, and 4-6 months following the completion of treatment.
Read the detailed description
In addition, the mechanism of non-responsiveness of HCV patients to IFNa will be studied. For this purpose, formation of complexes between STAT1 and its negative regulator, PIAS1 (immunoprecipitation, Western blot) will be examined. In comparing subjects on standard therapy vs the addition of betaine, (under separate studies) we will assess whether the formation of STAT1-PIAS1 complexes is due to impaired methylation on STAT1 on arginine residues which may be over come by the addition of betaine.
- Conditions
- Chronic Hepatitis C
- Being tested
- Blood sampling of peripheral blood mononuclear cells, Blood draw, 20ml peripheral blood mononuclear cells
- Keywords
- Chronic hepatitis C, Genotype 1
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling of peripheral blood mononuclear cellsProcedure or surgery
Group 1, (Patients): PMBC (20 ml blood) to be drawn at baseline, weeks 4 and 12 during antiviral therapy and 24 weeks following the end of antiviral therapy
Blood draw, 20ml peripheral blood mononuclear cellsProcedure or surgery
One time blood draw of 20 ml
| Study group | Role | What they receive |
|---|---|---|
| Patients | 20 patients with genotype 1, chronic hepatitis C who are to undergo standard antiviral therapy Receives: Procedure: Blood sampling of peripheral blood mononuclear cells | |
| control | Group 2, (control): 10 healthy family members or significant others of patients who are to undergo standard antiviral therapy Receives: Procedure: Blood draw, 20ml peripheral blood mononuclear cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment
To investigate the prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment
Measured: 3 years
Secondary outcomes (1)
Effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells
To determine the effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study start15 Apr 2009
- Primary completion8 Jan 2010
- Study completion8 Jan 2010
Why it stopped: no accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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 Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark E Mailliard, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876174
- Sponsor's protocol ID
- 0143-09-EP
- Status last verified
- Aug 2023
- First submitted
- 2 Apr 2009
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00876174
- Acronym / sponsor ID
- 0143-09-EP
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic hepatitis C, Genotype 1
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 15 Apr 2009 (actual)
- Primary completion
- 8 Jan 2010 (actual)
- Study completion
- 8 Jan 2010 (actual)
- First posted
- 6 Apr 2009 (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.
The objective of this pilot project is to investigate the prognostic criteria for sensitivity of Chronic Hepatitis C (CHC) Genotype 1, patients to IFNa treatment. Signal transduction in peripheral blood mononuclear cell (PBMC) of control groups will be compared with that of CHC patients. For this study, 20 patients with Hepatitis C virus (HCV) infection who are to undergo standard antiviral therapy and 10 healthy donors (significant others of the HCV subject) will be enrolled. Signal transduction will be studied in peripheral blood of CHC subjects before the treatment, after 1 and 3 months of treatment, and 4-6 months following the completion of treatment.
Detailed description
In addition, the mechanism of non-responsiveness of HCV patients to IFNa will be studied. For this purpose, formation of complexes between STAT1 and its negative regulator, PIAS1 (immunoprecipitation, Western blot) will be examined. In comparing subjects on standard therapy vs the addition of betaine, (under separate studies) we will assess whether the formation of STAT1-PIAS1 complexes is due to impaired methylation on STAT1 on arginine residues which may be over come by the addition of betaine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Blood sampling of peripheral blood mononuclear cells20 patients with genotype 1, chronic hepatitis C who are to undergo standard antiviral therapy |
| control | – | Procedure: Blood draw, 20ml peripheral blood mononuclear cellsGroup 2, (control): 10 healthy family members or significant others of patients who are to undergo standard antiviral therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with genotype 1, chronic hepatitis C who are to undergo antiviral therapy and their healthy family member or significant other
Key inclusion criteria (5 listed)
- 19 years of age or older, of either gender
- History of chronic hepatitis C documented by HCVRNA or healthy family member/significant other
- Documented genotype 1 for hepatitis participants or no hepatitis infection for healthy control
- Subject prescribed antiviral therapy for hepatitis participants or none for healthy control
- Able to give informed consent
Key exclusion criteria (2 listed)
- Under 19 years of age
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling of peripheral blood mononuclear cellsGroup 1, (Patients): PMBC (20 ml blood) to be drawn at baseline, weeks 4 and 12 during antiviral therapy and 24 weeks following the end of antiviral therapy | Procedure or surgery | Patients |
| Blood draw, 20ml peripheral blood mononuclear cellsOne time blood draw of 20 ml | Procedure or surgery | control |
Primary outcome
Prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment
Time frame: 3 years
To investigate the prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment
1 secondary outcome
Effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells
Time frame: 3 years
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 16 Aug 2023.
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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.
Mark E Mailliard, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by University of Nebraska.
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 5 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 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment (time frame: 3 years). It is what the study was designed to measure, not a finding.
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 16 Aug 2023.