Hepatitis CNCT02532907
Study of Hepatic Responses in Patients Receiving Direct-acting Anti-HCV Drugs
An observational study of Hepatitis C, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study is designed to obtain and store samples of serum and liver tissue in HCV (HepC Virus)-infected patients being treated with direct-acting antiviral (DAA) therapy, and to determine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Liver Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 10 Jul 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recruitment of patients will primarily occur through the Hepatology clinic, so non-veterans will be recruited. A total of 20 HCV-positive patients who will be treated with FDA-approved treatments as covered by the patient's insurance. Half of the patients will be treatment-naïve prior to enrollment and half will be treatment-experienced with either null response or relapse, i.e., persistent viremia. An equal proportion in each group will be biopsied at 4 versus 12 weeks after first dosing of DAA. Patients will be subjected to two biopsies during the life of the study.
Who may be able to join
- Signed informed consent
- Ages 18-70
- HCV-infected patients being treated with direct-acting antiviral (DAA) therapy.
Who cannot join
- Pregnant women or females of childbearing potential that are not on contraception
- Institutionalized or mentally disabled persons
- Prisoners
- Unwilling or unable to provide informed consent
- Subjects who are HIV positive
- Anticipated inability to follow up
Show all 11Show fewer
- Chronic anemia
- Platelet count < 100 for liver biopsy patients who have documented fatty liver disease by ultrasound prior to enrollment
- Any patient with bleeding disorders or prolonged INR
- Abstinent or consuming less than two drinks of alcohol per day.
- Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to obtain and store samples of serum and liver tissue in HCV (HepC Virus)-infected patients being treated with direct-acting antiviral (DAA) therapy, and to determine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood.
The introduction of new DAAs regimens that do not include IFN provides unique and novel opportunities to examine whether successful treatment-induced eradication of viral antigen results in reconstitution of T cell immunity. serum and liver tissue samples will be collected and stored in hopes of improving treatment and outcomes for future patients.
Read the detailed description
This study is designed to obtain and store samples of serum and liver tissue in HCV-infected patients being treated with DAA therapy.
A liver biopsy will be performed pre-treatment for research reasons. A small liver sample that is not required for pathologic analysis will also be stored. Patients will undergo another liver biopsy at either 4 or 12 weeks after initiation of DAA therapy.
Any patients with HCV-related liver disease (age > 18) will be considered for this study.
Patients will have a 120 ml blood draw for research purposes at baseline and 12 weeks after stopping DAA treatment along with a 60 ml blood draw at 2, 4, 8, and 12 weeks of treatment.
The liver biopsy at baseline and then either at 4 or 12 weeks will be examined using molecular techniques to measure transcription of key genes involved in the antiviral response.
- Conditions
- Hepatitis C
- Being tested
- Liver Biopsy
- Keywords
- HCV
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver BiopsyProcedure or surgery
patients will get a research liver biopsy pre-DAA treatment and either 4 or the standard 12 week time point. The liver biopsy is performed using standard protocol with ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who will have their second Liver biopsy at week 4 | The 4 week time point is performed in lieu of the 12 week and the purpose of this time point is to evaluate earlier responses and transcriptional changes that might predict viral clearance or treatment failure in a subset of patients. Receives: Procedure: Liver Biopsy | |
| Patients who will have their second Liver biopsy at week 12 | Liver biopsies will be obtained at week 12 when most DAA treatments end in order to compare the hepatic responses induced or reduced by clearance of HCV Receives: Procedure: Liver Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gene array from baseline to either 4 or 12 weeks after treatment.
To examine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo Rosen, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532907
- Sponsor's protocol ID
- 14-1794
- Other IDs
- UL1TR001082
- Status last verified
- Sep 2018
- First submitted
- 13 Aug 2015
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Golden-Mason L, Palmer B, Klarquist J, Mengshol JA, Castelblanco N, Rosen HR. Upregulation of PD-1 expression on circulating and intrahepatic hepatitis C virus-specific CD8+ T cells associated with reversible immune dysfunction. J Virol. 2007 Sep;81(17):9249-58. doi: 10.1128/JVI.00409-07. Epub 2007 Jun 13.
PubMed 17567698
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hepatic Responses in Patients Receiving Direct-acting Anti-HCV Drugs
- ClinicalTrials.gov ID
- NCT02532907
- Acronym / sponsor ID
- 14-1794
- Conditions
- Hepatitis C
- Keywords
- HCV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 26 Aug 2015 (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.
This study is designed to obtain and store samples of serum and liver tissue in HCV (HepC Virus)-infected patients being treated with direct-acting antiviral (DAA) therapy, and to determine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood.
The introduction of new DAAs regimens that do not include IFN provides unique and novel opportunities to examine whether successful treatment-induced eradication of viral antigen results in reconstitution of T cell immunity. serum and liver tissue samples will be collected and stored in hopes of improving treatment and outcomes for future patients.
Detailed description
This study is designed to obtain and store samples of serum and liver tissue in HCV-infected patients being treated with DAA therapy.
A liver biopsy will be performed pre-treatment for research reasons. A small liver sample that is not required for pathologic analysis will also be stored. Patients will undergo another liver biopsy at either 4 or 12 weeks after initiation of DAA therapy.
Any patients with HCV-related liver disease (age > 18) will be considered for this study.
Patients will have a 120 ml blood draw for research purposes at baseline and 12 weeks after stopping DAA treatment along with a 60 ml blood draw at 2, 4, 8, and 12 weeks of treatment.
The liver biopsy at baseline and then either at 4 or 12 weeks will be examined using molecular techniques to measure transcription of key genes involved in the antiviral response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who will have their second Liver biopsy at week 4 | – | Procedure: Liver BiopsyThe 4 week time point is performed in lieu of the 12 week and the purpose of this time point is to evaluate earlier responses and transcriptional changes that might predict viral clearance or treatment failure in a subset of patients. |
| Patients who will have their second Liver biopsy at week 12 | – | Procedure: Liver BiopsyLiver biopsies will be obtained at week 12 when most DAA treatments end in order to compare the hepatic responses induced or reduced by clearance of HCV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment of patients will primarily occur through the Hepatology clinic, so non-veterans will be recruited. A total of 20 HCV-positive patients who will be treated with FDA-approved treatments as covered by the patient's insurance. Half of the patients will be treatment-naïve prior to enrollment and half will be treatment-experienced with either null response or relapse, i.e., persistent viremia. An equal proportion in each group will be biopsied at 4 versus 12 weeks after first dosing of DAA. Patients will be subjected to two biopsies during the life of the study.
Key inclusion criteria (3 listed)
- Signed informed consent
- Ages 18-70
- HCV-infected patients being treated with direct-acting antiviral (DAA) therapy.
Key exclusion criteria (11 listed)
- Pregnant women or females of childbearing potential that are not on contraception
- Institutionalized or mentally disabled persons
- Prisoners
- Unwilling or unable to provide informed consent
- Subjects who are HIV positive
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 |
|---|---|---|
| Liver Biopsypatients will get a research liver biopsy pre-DAA treatment and either 4 or the standard 12 week time point. The liver biopsy is performed using standard protocol with ultrasound guidance. | Procedure or surgery | Patients who will have their second Liver biopsy at week 12, Patients who will have their second Liver biopsy at week 4 |
Primary outcome
Changes in gene array from baseline to either 4 or 12 weeks after treatment.
Time frame: 1 year
To examine the effect of new DAA therapies on HCV-related responses in the liver and peripheral blood.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Background: PubMed 17567698Golden-Mason L, Palmer B, Klarquist J, Mengshol JA, Castelblanco N, Rosen HR. Upregulation of PD-1 expression on circulating and intrahepatic hepatitis C virus-specific CD8+ T cells associated with reversible immune dysfunction. J Virol. 2007 Sep;81(17):9249-58. doi: 10.1128/JVI.00409-07. Epub 2007 Jun 13.
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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.
Hugo Rosen, MD principal investigator
University of Colorado, Denver
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 Colorado, Denver at 1 site in United States.
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 11 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: finished, as of the sponsor's last update on 19 Sep 2018. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in gene array from baseline to either 4 or 12 weeks after treatment. (time frame: 1 year). 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 NCT02532907, which also lists 1 linked publication.
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 19 Sep 2018.