Hepatitis CPhase 1ITX5061NCT01292824
Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients
A Phase 1 study testing ITX 5061 in people with Hepatitis C and Evidence of Liver Transplantation, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
This is a phase I pilot study to determine the safety and preliminary efficacy of a novel hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Evidence of Liver Transplantation
- What is being tested?
- ITX 5061
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to May 2013
- Phase
- Phase 1
- 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
Who may be able to join
- Age ≥ 18 years old, ≤ 65 years old
- Plasma HCV RNA positive at time of listing for liver transplantation
- Accepted for liver transplantation for any of:
- End-stage liver disease due to HCV infection
- End-stage liver disease due to HCV infection and alcohol related liver disease (ALD)
- HCC due to HCV
Who cannot join
- Refusal or inability to give informed consent
- Viral co-infection with either hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Pregnancy or breastfeeding
- Women, of child-bearing potential, who are not willing to practice effective contraception
- Men, sexually active with women of child-bearing potential, who are not willing to practice effective contraception
- Any situation that in the Investigator's opinion may interfere with optimal study participation
- Participation in any clinical study of an investigational agent within 30 days of recruitment
- Transplantation with a donor organ from a HCV positive individual
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Birmingham
Birmingham, West Midlands, B15 2TH
About this study
Official title: Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection
This is a phase I pilot study to determine the safety and preliminary efficacy of a novel hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing liver transplantation.
Read the detailed description
Hepatitis C virus (HCV) infection is common and treatment options at present are limited. Recurrence of HCV infection after liver transplantation is inevitable and disease progression is rapid when compared with disease in the non-transplanted liver.
Studies of ITX 5061 in vitro have shown it to be a potent inhibitor of HCV entry into hepatocytes, through blocking the interaction of the virus with scavenger receptor BI suggesting it may reduce graft re-infection rates after liver transplant.
There are no studies of treatments to block host receptors for HCV and the investigators hypothesize that ITX 5061 will modulate HCV kinetics in the early phase post liver transplant.
- Conditions
- Hepatitis C, Evidence of Liver Transplantation
- Being tested
- ITX 5061
- Keywords
- Hepatitis C virus, Entry, Scavenger receptor-BI, High density lipoprotein, Liver transplantation
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITX 5061Drug
ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Standard liver transplant care | No intervention | Liver Transplantation as per Standard of Care |
| ITX 5061 | Experimental | Liver Transplantation as per Standard of Care + ITX5061 Receives: Drug: ITX 5061 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of ITX 5061 in liver transplant recipients
Safety will be assessed by determination of the frequency of:
- perioperative events: including transfusion requirements and vasopressor requirements
- post-operative events: including primary graft non-function, hepatic artery thrombosis, acute cellular rejection and infective complications
Measured: 90 days
Secondary outcomes (2)
To determine whether treatment leads to an alteration in HCV RNA kinetics in the first week after liver transplantation
Hepatitis C virus titers will be measured at multiple times in the peri- and immediate post-operative period and kinetics assessed at 7 days after liver transplant.
Measured: One week
To determine whether any change in early viral kinetics is sustained
Hepatitis C virus titers will be measured at multiple times in the post-operative period and kinetics assessed at 90 days after liver transplant.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2013
- Study completionMay 2013
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- David J Mutimer, FRCP, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292824
- Sponsor's protocol ID
- RG_10-104
- Other IDs
- 2010-020358-32
- Acronym
- ITX5061
- Status last verified
- Dec 2015
- First submitted
- 9 Feb 2011
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Syder AJ, Lee H, Zeisel MB, Grove J, Soulier E, Macdonald J, Chow S, Chang J, Baumert TF, McKeating JA, McKelvy J, Wong-Staal F. Small molecule scavenger receptor BI antagonists are potent HCV entry inhibitors. J Hepatol. 2011 Jan;54(1):48-55. doi: 10.1016/j.jhep.2010.06.024. Epub 2010 Aug 21.
PubMed 20932595Rowe IA, Tully DC, Armstrong MJ, Parker R, Guo K, Barton D, Morse GD, Venuto CS, Ogilvie CB, Hedegaard DL, McKelvy JF, Wong-Staal F, Allen TM, Balfe P, McKeating JA, Mutimer DJ. Effect of scavenger receptor class B type I antagonist ITX5061 in patients with hepatitis C virus infection undergoing liver transplantation. Liver Transpl. 2016 Mar;22(3):287-97. doi: 10.1002/lt.24349.
PubMed 26437376
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Hepatitis C Virus (HCV) Entry Inhibitor (ITX 5061) in Liver Transplant Recipients With HCV Infection
- ClinicalTrials.gov ID
- NCT01292824
- Acronym / sponsor ID
- ITX5061 / RG_10-104
- Conditions
- Hepatitis C, Evidence of Liver Transplantation
- Keywords
- Hepatitis C virus, Entry, Scavenger receptor-BI, High density lipoprotein, Liver transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- University Hospital Birmingham, National Institute for Health Research, United Kingdom
- Study start
- Feb 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Feb 2011 (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 is a phase I pilot study to determine the safety and preliminary efficacy of a novel hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing liver transplantation.
Detailed description
Hepatitis C virus (HCV) infection is common and treatment options at present are limited. Recurrence of HCV infection after liver transplantation is inevitable and disease progression is rapid when compared with disease in the non-transplanted liver.
Studies of ITX 5061 in vitro have shown it to be a potent inhibitor of HCV entry into hepatocytes, through blocking the interaction of the virus with scavenger receptor BI suggesting it may reduce graft re-infection rates after liver transplant.
There are no studies of treatments to block host receptors for HCV and the investigators hypothesize that ITX 5061 will modulate HCV kinetics in the early phase post liver transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard liver transplant care | No intervention | –Liver Transplantation as per Standard of Care |
| ITX 5061 | Experimental | Drug: ITX 5061Liver Transplantation as per Standard of Care + ITX5061 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old, ≤ 65 years old
- Plasma HCV RNA positive at time of listing for liver transplantation
- Accepted for liver transplantation for any of:
- End-stage liver disease due to HCV infection
- End-stage liver disease due to HCV infection and alcohol related liver disease (ALD)
Key exclusion criteria (8 listed)
- Refusal or inability to give informed consent
- Viral co-infection with either hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Pregnancy or breastfeeding
- Women, of child-bearing potential, who are not willing to practice effective contraception
- Men, sexually active with women of child-bearing potential, who are not willing to practice effective contraception
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 |
|---|---|---|
| ITX 5061ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week. | Drug | ITX 5061 |
Primary outcome
To determine the safety of ITX 5061 in liver transplant recipients
Time frame: 90 days
Safety will be assessed by determination of the frequency of: * perioperative events: including transfusion requirements and vasopressor requirements * post-operative events: including primary graft non-function, hepatic artery thrombosis, acute cellular rejection and infective complications
2 secondary outcomes
To determine whether treatment leads to an alteration in HCV RNA kinetics in the first week after liver transplantation
Time frame: One week
To determine whether any change in early viral kinetics is sustained
Time frame: 90 days
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 3 Dec 2015.
- Background: PubMed 20932595Syder AJ, Lee H, Zeisel MB, Grove J, Soulier E, Macdonald J, Chow S, Chang J, Baumert TF, McKeating JA, McKelvy J, Wong-Staal F. Small molecule scavenger receptor BI antagonists are potent HCV entry inhibitors. J Hepatol. 2011 Jan;54(1):48-55. doi: 10.1016/j.jhep.2010.06.024. Epub 2010 Aug 21.
- Results publication: PubMed 26437376Rowe IA, Tully DC, Armstrong MJ, Parker R, Guo K, Barton D, Morse GD, Venuto CS, Ogilvie CB, Hedegaard DL, McKelvy JF, Wong-Staal F, Allen TM, Balfe P, McKeating JA, Mutimer DJ. Effect of scavenger receptor class B type I antagonist ITX5061 in patients with hepatitis C virus infection undergoing liver transplantation. Liver Transpl. 2016 Mar;22(3):287-97. doi: 10.1002/lt.24349.
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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.
David J Mutimer, FRCP principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITX 5061 in people with Hepatitis C and Evidence of Liver Transplantation, run by University of Birmingham at 1 site in United Kingdom.
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 6 inclusion and 8 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 3 Dec 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 Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To determine the safety of ITX 5061 in liver transplant recipients (time frame: 90 days). 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 NCT01292824, 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 3 Dec 2015.