Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients
NCT ID: NCT01292824
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2011-02-28
2013-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard liver transplant care
Liver Transplantation as per Standard of Care
No interventions assigned to this group
ITX 5061
Liver Transplantation as per Standard of Care + ITX5061
ITX 5061
ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.
Interventions
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ITX 5061
ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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University Hospital Birmingham
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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David J Mutimer, FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham
Locations
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University Hospital Birmingham
Birmingham, West Midlands, United Kingdom
Countries
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References
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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.
Rowe 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.
Other Identifiers
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2010-020358-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RG_10-104
Identifier Type: -
Identifier Source: org_study_id