Hepatitis CNCT01517529
Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations
An observational study of Hepatitis C, run by University of Cincinnati at 1 site in United States.
Trial summary
The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Investigators plan to enroll 20 human subjects with chronic hepatitis C virus infection from the outpatient clinic at the University of Cincinnati College of Medicine.
Who may be able to join
None listed.
Who cannot join
- Treatment naïve chronically HCV-infected patients.
- Patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases, including rheumatoid arthritis, and any patients on systemic immunomodulators.
- Pregnancy
- HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Role of the Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy
The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.
Read the detailed description
Objective 1: Evaluate the role of the immune responses in determining the emergence of HCV NS3 resistance mutation during protease inhibitor therapy
Hypothesis 1 (HT 1): Low HLA binding to peptides containing protease inhibitor resistance mutations is associated with the emergence of protease inhibitor mutants during therapy and failure of the treatment.
Hypothesis 2 (HT 2): A hole in T cell repertoire may allow emergence of protease inhibitor mutants during protease inhibitor therapy which leads to loss of the immune responses to these mutants and failure of treatment.
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, 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.
| Study group | Role | What they receive |
|---|---|---|
| 10 Hepatitis C infected subjects | 10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed Standard Treatment
Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.
Measured: 9 months
Secondary outcomes (1)
Number of Participants Who Cleared the Virus
Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 CincinnatiThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Mohamed Tarek Shata, University of Cincinnati
- Investigators
- Mohamed Tarek. M Shata, MD, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517529
- Sponsor's protocol ID
- UC 11101915
- Status last verified
- Oct 2015
- First submitted
- 20 Jan 2012
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Abdel-Hameed EA, Rouster SD, Ji H, Ulm A, Hetta HF, Anwar N, Sherman KE, Shata MT. Evaluating the Role of Cellular Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy. Viral Immunol. 2016 May;29(4):252-8. doi: 10.1089/vim.2015.0093. Epub 2016 Feb 17.
PubMed 26885675
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of the Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT01517529
- Acronym / sponsor ID
- UC 11101915
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, HCV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Posted 30 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.
Detailed description
Objective 1: Evaluate the role of the immune responses in determining the emergence of HCV NS3 resistance mutation during protease inhibitor therapy
Hypothesis 1 (HT 1): Low HLA binding to peptides containing protease inhibitor resistance mutations is associated with the emergence of protease inhibitor mutants during therapy and failure of the treatment.
Hypothesis 2 (HT 2): A hole in T cell repertoire may allow emergence of protease inhibitor mutants during protease inhibitor therapy which leads to loss of the immune responses to these mutants and failure of treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10 Hepatitis C infected subjects | – | –10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators plan to enroll 20 human subjects with chronic hepatitis C virus infection from the outpatient clinic at the University of Cincinnati College of Medicine.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Treatment naïve chronically HCV-infected patients.
- Patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases, including rheumatoid arthritis, and any patients on systemic immunomodulators.
- Pregnancy
- HIV
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
Number of Participants Who Completed Standard Treatment
Time frame: 9 months
Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.
1 secondary outcome
Number of Participants Who Cleared the Virus
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26885675Abdel-Hameed EA, Rouster SD, Ji H, Ulm A, Hetta HF, Anwar N, Sherman KE, Shata MT. Evaluating the Role of Cellular Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy. Viral Immunol. 2016 May;29(4):252-8. doi: 10.1089/vim.2015.0093. Epub 2016 Feb 17.
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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.
Mohamed Tarek. M Shata, MD, PhD principal investigator
University of Cincinnati
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 Cincinnati 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 0 inclusion and 4 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 20 Nov 2015. 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?
Yes. Results are posted in the registry (first posted 30 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Completed Standard Treatment (time frame: 9 months). 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 NCT01517529, 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 20 Nov 2015.